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The Bone & Joint Journal
Vol. 97-B, Issue 3 | Pages 366 - 371
1 Mar 2015
Patel MS Newey M Sell P

Minimal clinically important differences (MCID) in the scores of patient-reported outcome measures allow clinicians to assess the outcome of intervention from the perspective of the patient. There has been significant variation in their absolute values in previous publications and a lack of consistency in their calculation.

The purpose of this study was first, to establish whether these values, following spinal surgery, vary depending on the surgical intervention and their method of calculation and secondly, to assess whether there is any correlation between the two external anchors most frequently used to calculate the MCID.

We carried out a retrospective analysis of prospectively gathered data of adult patients who underwent elective spinal surgery between 1994 and 2009. A total of 244 patients were included. There were 125 men and 119 women with a mean age of 54 years (16 to 84); the mean follow-up was 62 months (6 to 199) The MCID was calculated using three previously published methods.

Our results show that the value of the MCID varies considerably with the operation and its method of calculation. There was good correlation between the two external anchors. The global outcome tool correlated significantly better.

We conclude that consensus needs to be reached on the best method of calculating the MCID. This then needs to be defined for each spinal procedure. Using a blanket value for the MCID for all spinal procedures should be avoided.

Cite this article: Bone Joint J 2015;97-B:366–71.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_6 | Pages 22 - 22
1 Apr 2014
Soh R Sell P
Full Access

Aim:

The introduction of novel systems for correction of scoliosis should be subject to critical analysis and based on patient benefit.

Methods:

Retrospective analysis of prospective data from a single surgeon consecutive series of Lenke 1 type curves. The two cohorts compared K2M and AOUSS2. Pre and Post operation Cobb angle, flexibility, absolute correction rate, implant related correction, levels fused, implant density, implant cost and cost per Cobb improvement analysis were collected.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 11 - 11
1 Feb 2014
Lee KC Khan A Longworth S Sell P
Full Access

Introduction

There has been a recent surge in the interest of the role of vitamin D in chronic musculoskeletal pain however there are limited studies that have investigated the link of vitamin D hypovitaminosis with low back pain. The aim of our study was to determine the prevalence of low vitamin D levels in patients who present with low back pain in an outpatient setting in the UK.

Methods

Data was collected retrospectively from computerised databases of all patients who presented with low back pain from a single spinal consultant's outpatient clinic and have had serum levels of 25-hydroxycholecalciferol (25-OH vitamin D) requested. Data of these patients were collected from hospital electronic and paper records and analysed against their serum 25-OH vitamin D levels.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 25 - 25
1 Feb 2014
Lee KC Patel S Sell P
Full Access

Introduction

Yellow flags are psychosocial indicators which are associated with a greater likelihood of progression to persistent pain and disability and are referred to as obstacles to recovery. It is not known how effective clinicians are in detecting them. Our objective was to determine if clinicians were able to detect them in secondary care.

Methods

111 new referrals in a specialist spine clinic completed the Oswestry Disability Index (ODI) and a range of other validated questionnaires including the yellow flag questionnaire adapted from the psychosocial flags framework. Clinicians blinded to the patient data completed a standardized form to determine which and how many yellow flags they had identified.


The Bone & Joint Journal
Vol. 95-B, Issue 1 | Pages 90 - 94
1 Jan 2013
Patel MS Braybrooke J Newey M Sell P

The outcome of surgery for recurrent lumbar disc herniation is debatable. Some studies show results that are comparable with those of primary discectomy, whereas others report worse outcomes. The purpose of this study was to compare the outcome of revision lumbar discectomy with that of primary discectomy in the same cohort of patients who had both the primary and the recurrent herniation at the same level and side.

A retrospective analysis of prospectively gathered data was undertaken in 30 patients who had undergone both primary and revision surgery for late recurrent lumbar disc herniation. The outcome measures used were visual analogue scales for lower limb (VAL) and back (VAB) pain and the Oswestry Disability Index (ODI).

There was a significant improvement in the mean VAL and ODI scores (both p < 0.001) after primary discectomy. Revision surgery also resulted in improvements in the mean VAL (p < 0.001), VAB (p = 0.030) and ODI scores (p < 0.001). The changes were similar in the two groups (all p > 0.05).

Revision discectomy can give results that are as good as those seen after primary surgery.

Cite this article: Bone Joint J 2013;95-B:90–4.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 15 - 15
1 Jan 2013
Patel M Newey M Sell P
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Background

The majority of studies assessing minimal clinical important difference in outcome do so for management of chronic low back pain. Those that identify MCID following spinal surgical intervention fail to differentiate between the different pathologies and treatments or use variable methods and anchors in the calculation.

Aim

To identify the MCID in scores across the most common spinal surgical procedures using standardised methods of calculation.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 184 - 184
1 Jan 2013
Perianayagam G Newey M Sell P
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Background

In 2009, NICE CG 88 guideline on the management of non-specific low back pain was published. We looked at whether the introduction of these guidelines has had an impact on the management of back pain within primary care.

Methods

Patients with non-specific low back pain (> 6 weeks but < 12 months) attending spinal outpatient clinic in UHL between 2008 and 2011 were asked to complete questionnaires. Two groups were studied, the first prior to the publication of NICE guidelines, and the second afterwards. Patients with radicular, stenotic and red flag symptoms were excluded. Key audited treatment standards assessed included manual therapy, acupuncture, focused structured back exercise program, supervised group exercise program and lastly referral to a combined physical and psychological treatment program. Compliance with not using X-ray or MRI and treatment modalities such as injections, laser therapy, ultrasound therapy, lumbar supports, traction and TENS therapy was assessed. Secondary outcomes included VAS (back, leg pain), Oswestry Disability Index, MSP and MZD. Primary outcomes analyzed using 1-sided Fisher's exact test and secondary outcomes using two sample t tests.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 98 - 98
1 Sep 2012
Patel M Sell P
Full Access

Introduction

In all traumatic injury there is a clear relationship between the structural tissue damage and resultant disability after recovery. There are no publications that compare significant thoracolumbar osseous injury to non specific soft tissue injury.

Aim

To compare spinal outcome measures between patients with self reported back pain in the workplace perceived as injury to those having sustained structural injury in the form of an unstable thoracolumbar fracture requiring surgical stabilisation.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXI | Pages 6 - 6
1 Jul 2012
silmissä K Öga IB Øjnene der ser I Sell P Sell B
Full Access

It is not known how parents of children with scoliosis perceive cosmetic issues in their offspring. There is little clinical information regarding parental 'surrogate' assessment of a young persons' fears and beliefs regarding how a deformity affects the child and how that might influence the process of informed consent and surgical risk assessment.

Method

Patients and their parents had a structured interview involving SRS20 and Walter Reed Visual Assessment Scale. The parents were asked to complete an SRS20 as they expected their child to complete it. That is they were asked to anticipate how the child might score and grade the SRS 20.

Results

28 patients, 6 males, 22 females, 8 females were pre-menarche, mean age 14 (12-17), mean cobb angle 57, completed the study. Mean parental age 45. There were 6 fathers and 22 mothers.

The mean SRS scores for the domains for children were pain 2.49, self image 2.3 function 2.9 Mental health 2.9 Total 10.7.

The mean SRS scores for the domains for the parents were pain 2.38 self image 2.39 function 2.97 Mental health 2.87 Total 10.5

There was no significant difference between mean scores for the four domains of the SRS20


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 73 - 73
1 Jun 2012
Patel MS Young A Sell P
Full Access

Aim

To identify a means to reduce the duration and radiation dose coupled with fluoroscopic guided nerve root blocks (NRB).

Method

Consecutive prospective two cohort comparative study. A similar method performed during CT guided NRBs was employed to guide needle placement for transforaminal nerve root injections with the aid of static MR images and fluoroscopy.

Axial MR images at the level of the target nerve root were used. An angle of inclination of 60 degrees was created from the nerve root to the skin of the back, the apex of this to represent the site of needle introduction. Triangulation on the MRI enabled the lateral entry point to be determined.

The transforaminal injections were then performed with the simple expedient of a skin marker line at the appropriate lateral distance from the midline for needle entry. The radiation dose and fluoroscopic time as measured by the image intensifier were recorded. This method was performed for 20 patients and compared to the same parameters for 23 previous patients in whom the transforaminal injections were performed without such a technique.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 7 - 7
1 Jun 2012
Patel MS Braybrooke J Newey M Sell P
Full Access

Aim

To compare outcomes of revision lumbar discectomy to primary surgery in the same patient cohort.

Methods

Prospective outcome data in 36 patients who underwent primary and subsequent revision surgery for lumbar disc herniation between 1995 and 2009. Outcome measures used were Visual Analogue Scores for back (VAB) and leg pain (VAL), the Oswestry Disability Index (ODI) and Low Back Outcome Score (LBO). 5 early recurrences within 3 months were excluded.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 24 - 24
1 Jun 2012
Venkatesan M Fong A Sell P
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Background

Thoracolumbar fractures are the most common spinal injuries resulting from blunt trauma. Missed spinal injuries can have serious consequences.

Objective

Our objectives were to determine the utility of trauma series chest and abdomen computed tomographs for detecting clinically unrecognised vertebral fractures and to analyse those missed on clinical examination. The aim was to identify an ‘at-risk’ patient group with negative clinical examination warranting evaluation with CT screening.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 30 - 30
1 Jun 2012
Patel MS Sell P
Full Access

Aim

To compare spinal outcome measures between patients reviewed for medico-legal compensation claims relating to perceived injury at work to those having sustained serious structural injury in the form of unstable thoraco-lumbar fractures requiring internal fixation.

Method

Two consecutive cohorts of 23 patients with healed spinal fractures and 21 patients with a perception of work related soft tissue injury were compared. Patient demographics and a range of outcome measures including Oswestry Disability Index (ODI), Low Back Outcome score (LBOS), Modified Somatic Perception (MSP) and Modified Zung Depression (MZD) indices were measured.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 37 - 37
1 Apr 2012
Leung Y Sell P
Full Access

To prospectively determine the relationship between the two most commonly used generic spinal outcome measures, the Oswestry Disability Index (ODI) and the Low Back Outcome Score (LBOS).

Outcome measures inform audit and research. Few spine surgical specific outcome measures are in general use. Generic measures are used for a variety of spinal disorders it is not known which is best or exactly how they relate for different conditions. Pre-operatively and two years post surgical results were available in 240 patients. There were 125 males, 115 females. Sub groups numbering 82 discetomy, 78 decompression, 26 revision and 19 fusions were analysed.

Average age 55 years (range 23-88). The pre op average ODI was 55% and the LBOS was 29. Correlation was -0.73. The overall post operative score at 2 years was 34% ODI and 37 LBOS, the correlation was better at -0.87.

The correlation between the two scores post operatively was very good for Discectomy surgery (-0.916) and fusion surgery (-0.907) but not so close pre operatively with Discectomy (-0.786) and fusion correlation poor at (-0.302). Revision surgery and decompression surgery had similar good correlation post operatively. The correlation of both outcome measures to the Modified Zung depression index was poor.

The poor pre operative correlation suggests that thresholds for surgery cannot be compared within registries using different measures. The post operative scores and change in scores correlate better. This is important in comparative studies using different outcomes scores within the same spine registry.

No conflict of Interest. Registered database and audit of service standard


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 102 - 102
1 Apr 2012
Rasul Z Boreham B Sell P
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Clinical and radiological indicators of outcome in the use of X-Stops were sought by evaluating patient-centred outcomes alongside radiographic scrutiny of changes around implants with correlation to outcome.

Prospectively collated outcome scores were correlated to outcome, with retrospective analysis of pre-operative MRI scans and 117 post-operative radiographs.

Single surgeon series of 44 patients(52 implants).

Clinical - ODI, walking distance, Low Back Outcome Score, MZDI and MSP. Radiographic - lucency(anterior and cranio-caudal to implant), coronal rotation, dorsal migration of implant. Failure defined by persistent symptoms requiring removal+/−decompression.

Pre-operative features of success: lower ODI(p<0.05), higher LBOS(p<0.01), higher walking distance(p<0.01), lower MZDI(p<0.01).

Marked differences were noted in post-operative scores for the two cohorts. An eight-fold improvement in walking distance in success patients compared to an increase to 1.8 times the baseline in failures. ODI improved ten times more in the success group at 20 cf2(failure). MZDI improvement was greater in the revisions at 2.2 cf 0.9 in successes.

Ranking Pearson's coefficient of radiograph measurements in success and failure cohorts, revealed failure associated most to anterior lucency(R=0.93), rotation(R=-0.61), cranio-caudal lucency (R=-0.29) and migration (R=-0.25). Success most associated to rotation (R=-0.22). Failure radiographs revealed greater lucency cranio-caudal and ventral to the implant, more coronal rotation, and pronounced dorsal migration.

Clinical features of success are older patients with no co-morbidities, unilateral leg pain and multi-level insertion. Males, those with bilateral leg pain, and scoliosis or spondylolistheses are more likely to fail.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 11 - 11
1 Apr 2012
Newey M Sell P
Full Access

The use of interspinous distraction devices should remain the subject of audit and research. They are a relatively new addition to the armamentarium of surgical treatment of lumbar spinal stenosis. The reported results are variable and there are a number of different devices available. It is recognised that there is an early failure rate with interspinous distraction devices. This is a report of the clinical results after conversion to segmental lumbar decompression following a failure of interspinous distraction procedure.

18 patients had removal of device and conversion to a standard lumbar decompression at an average of 13 months after the index procedure. There were 7 females and 11 males. The average age was 68 years (range 49-85). The two youngest patients had a decompression and instrumented fusion, the others had decompression alone. Prior to the Index procedure of stand alone interspinous distraction device the average Oswestry Disability Index (ODI) was 42 and Visual Analogue Score (VAS) leg 7.2. Prior to revision the average ODI was 42 and VAS leg 6.7.

Complications: One intra operative myocardial infarction, one incidental durotomy and one post operative infection (pseudomonas isolated).

At a mean of 9 months follow up the average ODI was 23 and VAS leg 2.1. The VAS back was 1.9. The walking distance was subjectively reported as 246 yards pre op and 1100 yards post procedure. There was a clinically significant improvement in all patients.

A failed interspinous distraction device can be satisfactorily salvaged with a segmental lumbar decompression.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 6 - 6
1 Apr 2012
Rushton P Grevitt M Sell P
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Comparison of clinical, radiological & functional outcomes of corrective surgery for right thoracic AIS curves.

There is a paucity of data relating functional outcomes to the radiological and surface measurement results of either posterior or anterior surgery for right thoracic AIS.

Prospective, cohort study, mean follow up 35 months (range 9-115)

38 patients (6 males); 22 Lenke 2 posterior, 16 Lenke 1 anterior.

Primary= rib hump, radiological (frontal Cobb correction, apical vertebral translation AVT, sagittal profile), Modified SRS Outcomes Instrument (MSRSI). Secondary= estimated blood loss (EBL), operative time, complications

No significant difference at P<0.005 with student t-test unless indicated

Rib Hump: 16° posterior 17 ° anterior, corrected to 8 ° (50%) and 6 ° (60%) respectively.

Thoracic Cobb: 70° posterior 61 ° anterior, corrected to 27° (61%) and 22° (64%) respectively. No difference in preoperative curve flexibility or fulcrum bending correction index. Thoracic AVT 55% correction posterior, 70% anterior, Lumbar Cobb 59% correction posterior, 52% anterior. Thoracic kyphosis significantly reduced in posterior surgery (35 ° to 20 °) and significantly increased with anterior surgery (21° to 30°). Lumbar lordosis significantly reduced with posterior surgery (88° to 47°), no significant change with anterior surgery (60° to 53°).

MSRSI; Domain scores similar preoperatively between groups. Difference scores (postop-preop), higher scores=better. Pain: +1.21 posterior +0.73 anterior. Self image: +1.02 posterior +0.71 anterior. Function/activity: +0.28 posterior +0.21 anterior. Mental health: +0.66 posterior +0.45 anterior.

No significant difference in complication rate, operative time or estimated blood loss

Similar cohorts of AIS patients treated by either anterior or posterior surgery have no significant differences in radiological or functional outcomes. The different final sagittal profile in both groups did not affect the MSRSI outcomes. Both procedures deliver significant health gains as measured by the MSRSI.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 28 - 28
1 Apr 2012
Rasul Z Sell P
Full Access

Establish the prevalence of B12 deficiency in patients presenting for surgical assessment and to audit subsequent management.

Retrospective: The pathology database was interrogated for all B12 and folate requests under the name of a Spine sub-specialty Consultant over a four year period (2005-2008). 38 patients with B12 deficiency were identified.

Patient self reported symptoms, drug history, Global outcome score (Much better, better, same, worse) Visual Analogue Score (VAS) and Oswestry Disability Index(ODI).

458 tests occurred. 38(8.3%) were B12 deficient. Of these, 10 (26%) had received no treatment at review.

Average age 63 years. 23 males, 15 females. 6 patients were diabetic. At clinic attendance Mean ODI 46%; VAS(leg) 6.4. A sample from those with a normal B12 had ODI 45%; VAS(leg) of 5.9.

Of the three who were “worse”, one had been treated. 7 of the 12 patients who felt the “same” had received injections. 9 were “better” with 5 on supplements. Five were “much better” with all patients on supplements.

Less than half(47%) were prescribed analgesia, 11 out of 38 were taking paracetamol, 6 were prescribed NSAIDs, 6 opiates, and 10 were taking neuropathic painkillers.

Reversible causes of neuropathic pain can only be identified by testing. A high index of suspicion resulted in positive tests in 8% of the population studied. Administrative obstacles exist to treatment. Those that are treated do better. Sensory symptoms in a spine clinic patient should not be assumed to originate exclusively from the spine.

Audit/service standard registered in Trust No conflict of interest


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 5 - 5
1 Apr 2012
Rushton P Grevitt M Sell P
Full Access

To determine the factors that influences the clinical outcomes in surgical correction of thoracic AIS.

There are conflicting data regarding the effects of back shape and radiologic parameters on the self-reported outcomes of surgery in AIS.

Prospective, cohort study; mean follow-up 29 months (range 9-88)

30 patients (5 males);

Rib hump 17 ° corrected to 7 °.

Thoracic Cobb 66 ° corrected to 25 ° (63%). Lumbar Cobb 42 ° corrected to 17°. Thoracic apical vertebral translation (AVT) 48mm corrected to 18mm. Lumbar AVT 34mm corrected to 19mm. Thoracic kyphosis 29° preoperatively 23° postoperatively. Lumbo-sacral lordosis 57° preoperatively 49° postoperatively

Modified SRS Outcomes Instrument (MSRSI) filled out pre-operatively and at final follow up.

Primary= rib hump, radiological (frontal Cobb correction, lumbar & thoracic AVT, sagittal profile), Modified SRS Outcomes Instrument (MSRSI) domain scores.

The magnitude of the rib hump had a significant association with pain:

Rib hump vs. MSRSI pain r= -0.55 p<0.000

Similar correlations existed between rib hump and self-image (r=-0.64, p<0.0000), thoracic Cobb angle with pain (r=-0.48 p<0.0001) and self-image (r= -0.57, P<0.0000). The postoperative thoracic Cobb angle, and percentage thoracic Cobb correction had significant correlations with self-image (r=-0.55 p=0.003 & r=0.54 p0.004 respectively).

The size of the rib hump has a significant impact on pain & self-image. These domains are also significantly influenced by the residual thoracic Cobb angle and overall scoliosis correction.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 24 - 24
1 Apr 2012
Sell P Quereshi A Sell B
Full Access

There remains debate regarding which surgical approach gives the best outcome, anterior alone or posterior alone, in surgically relevant adolescent idiopathic scoliosis. The operation is mainly cosmetic in terms of health care advantage. This prospective study evaluated scar site preference and other relevant body image parameters prior to any intervention.

Patients and their parents had a structured interview involving SRS20 and Walter Reed Visual Assessment Scale as well as grading of nine AP and lateral clinical photographs specifically of anterior and posterior scoliosis surgery scars. Each clinical image was graded 1-10 on a scale of unsatisfactory and satisfactory. Parents completed assessments as well as the patients.

Results: 28 patients, 6 males, 22 females, 8 females were pre-menarche, mean age 14 (12-17), mean cobb angle 57, completed the study. Mean parental age 45.

There was no significant difference between mean scores for the four anterior scar (6.36) and the five posterior scar (6.35) images. p value 0.49. In parents the preferences were more apparent posterior 6.9, anterior 6.2 but this was not statistically significant (p=0.06)

There was no significant difference between all four domains of the SRS between parent and child. In terms of expressed preference the child had no preference in 7, thoracotomy in 7 and posterior midline in 14, whereas parents expressed no preference in 12, thoracotomy in 4 and posterior midline in 12.

In this prospective study there was no perceived difference in acceptability of anterior or posterior scars for scoliosis surgery approaches.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 2 - 2
1 Mar 2012
Tafazal S Ng L Chaudhary N Sell P
Full Access

Objectives

The main objective of our study was to determine the treatment effect of corticosteroids in peri-radicular infiltration for radicular pain. We also examined whether there was any effect on the need for subsequent interventions such as additional root blocks and/or surgery.

Subjects and Method

In a randomised, double blind controlled trial, 150 eligible patients with radicular pain and unilateral symptoms who failed conservative management were randomised for a single injection with bupivacaine and methylprednisolone (b+s) or bupivacaine (b) alone. The outcome measures used included the Oswestry Disability Index (ODI), Low Back Outcome Score (LBOS), Visual Analogue Score (VAS) for leg pain and back pain and patient's subjective level of satisfaction of the outcome.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 289 - 289
1 Jul 2011
Okoro T Qureshi A Sell B Sell P
Full Access

Purpose of study: Self reported walking distance is a clinically relevant measure of function. Our aim was to report patient accuracy and understand factors that might influence perceived walking distance.

Method: A prospective cohort study. 103 patients were asked to perform one test of distance estimation and 2 tests of functional distance perception using pre-measured landmarks. Standard spine specific outcomes included the patient reported claudication distance, Oswestry disability index (ODI), Low Back Outcome Score (LBOS), visual analogue score (VAS) for leg and back, and Modified Zung Depression index (MZD).

Results: There are over-estimators and under-estimators. Overall the accuracy to within 10 yards was only 5% for distance estimation and 40% for the two tests of functional distance perception. Distance: Actual distance 121.4 yds; mean response 268yds (95% CI 192.8–344.15), Functional test 1 actual distance 32 yards; mean response 78.4 yds (95% CI 58.6–97.3), Functional test 2 actual distance 21.4yds; mean response 51.9yds (95% CI 38.3–65.5). Surprisingly patients over 60 years of age (n=43) are twice as accurate with each test performed compared to those under 60 (n=60) (average 70% overestimation compared to 140%; p=0.06). Patients in social class I (n=18) were more accurate than those in classes II–V (n= 85) (59% vs 131% p=0.13). There was a positive correlation between poor accuracy and increasing MZD (Pearson’s correlation coefficient 0.250; p=0.012). ODI, LBOS and other parameters measured showed no correlation.

Conclusions: Subjective distance perception and estimation is poor in this population. Patients over 60 and those with a professional background are more accurate.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 380 - 380
1 Jul 2010
Sell P
Full Access

Purpose: To describe the clinical, biomechanical and radiological features of a spinal implant failure

Method: Over a two year period 45 patients had treatment of spinal stenosis with the X-stop device. 38 had a single level treated, 7 had two level implants. Average age 68. Pre op walking distance 120 meters, Pre op Oswestry Disability Index (ODI) 45%.

11 patients have had implants removed, a 24% implant failure rate. Clinical failure also occurred in two patients unfit for revision. Prospective data on standard spine outcomes were analysed as well as the radiological and biomechanical features of failure.

Results: One year survivorship was 71%. At 6 months the average walking distance improved to 1430 meters, and the average ODI improved to 26%. Some patients exhibit dramatic improvements which obscures the failures.

There were two modes of failure, early, with a failure to improve after the procedure, and late, with an initial improvement and subsequent deterioration.

A consistent feature of late failure is bone resorption around the implant. This is apparent on post operative radiographs and is a progressive. Scalloping and erosion of bone is seen at revision surgery with the implant within a fibrous capsule. Late spinous process fracture occurred in a two level implant as a result of erosion.

Retrieved implants demonstrate scouring of the PEEK surface which increases with time.

Conclusion: Long term surveillance should be mandatory. The implant should be withdrawn from clinical use until trials establish long term efficacy and safety.

Ethics approval: Registered with Hospital new procedures advisory group audit

Interest Statement: No commercial support


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 382 - 382
1 Jul 2010
Okoro T Sell B Sell P
Full Access

Purpose: Self reported walking distance is a clinically relevant measure of function, our aim was to report patient accuracy and understand factors that might influence perceived walking distance.

Method: A prospective cohort study. 103 patients were asked to perform one test of distance estimation and 2 tests of functional distance perception using pre-measured landmarks. Standard spine specific outcomes included the patient reported claudication distance, Oswestry disability index (ODI), Low Back Outcome Score (LBOS), visual analogue score (VAS) for leg and back, and other measures.

Results: There are over-estimators and under-estimators. Overall the accuracy to within 10 yards was only 5% for distance estimation and 40% for the two tests of functional distance perception. Distance: Actual distance 121.4 yds; mean response 268yds (95% CI 192.8–344.15), Functional test 1 actual distance 32 yards; mean response 78.4 yds (95% CI 58.6–97.3) Functional test 2 actual distance 21.4yds; mean response 51.9yds (95% CI 38.3–65.5). Surprisingly patients over 60 years of age (n=43) are twice as accurate with each test performed compared to those under 60 (n=60) (average 70% overestimation compared to 140%; p=0.06). Patients in social class I (n=18) were more accurate than those in classes II–V (n= 85): There was a positive correlation between poor accuracy and increasing MZD (Pearson’s correlation coefficient 0.250; p=0.012). ODI, LBOS and other parameters measured showed no correlation.

Conclusions: Subjective distance perception and estimation is poor in this population. Patients over 60 and those with a professional background are more accurate.

Ethics approval: not required

Interest Statement: none


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 380 - 380
1 Jul 2010
Sell P Newey M
Full Access

Purpose: To determine the clinical effectiveness of a stand alone interspinous distraction device

Method: Prospective consecutive longitudinal study in five hospital sites. Outcome measures Oswestry Disability Index (ODI), Visual Analogue score for leg and back (VAS Leg, VAS Back). Implant failure determined by removal and revision.

A cohort of 69 patients having clinical and radiological evidence of spinal stenosis. Selected according to recommendations of clinical trials groups for the x-stop, i.e. sitting tolerance of greater than 30 minutes.

Clinical outcome data at average of 10 month (6–24) available for 66 patients (95% FU).

Average age 67 years ( Range 49–84). The average outcomes were Pre op ODI 42, Post op ODI 27. A change from baseline of 15 points. Pre op VAS leg 7.2 post op 4.4, and VAS Back Pre 4.8, post op 3.6

Taking a 16 point change in ODI as representing a clinically significant improvement half the study group failed to achieve this. A small number (17 patients 25%) had a dramatic improvement of greater than 24 points, which significantly skews the average change from baseline.

17 Revisions have occurred so far (24% failure rate)

Conclusion: A small proportion of successful results occur, however implant failure and revision rate is high.

Ethics approval: NPIAG registered audit

Interest Statement: No commercial or grant support


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 231 - 232
1 Mar 2010
Sivan M Sell B Sell P
Full Access

Background and Objective: The influence of back pain on work status is normally implied from the severity of the functional limitations. The aim of this cross sectional study was to analyse whether functional assessment instruments correlate well with impact on work status.

Patients and Methods: 375 chronic low back pain patients attending back pain outpatient clinics of a University Hospital and a specialist rehabilitation centre over a period of one year were assessed. The three functional outcome scores measured were Oswestry Disability Index (ODI), Roland Morris disability questionnaire (RMQ) and Orebro Musculoskeletal Pain Questionnaire (OMPQ). The effect of back pain on patient’s work status was recorded in 6 options – work not affected, slightly affected, seriously affected, reduced number of hours, change job or give up job. The work status score was then correlated to the above three instrument values.

Results: There was good correlation among the three instrument values (rho > 0.70) suggesting they are interchangeable. However, there was only a modest correlation between the work status scale and the three functional scores; the rho values were 0.47 for OMPQ, 0.43 for ODI and 0.39 for RMQ. There was no influence of age, duration of pain or type of work on this correlation.

Conclusion: Back pain instruments (which measure pain and functional limitations) and work status are not interchangeable. The impact on work status cannot be implied from these functional scores and should be recorded as a separate outcome measure.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 235 - 235
1 Mar 2010
Okoro T Tafazal S Longworth S Sell P
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Introduction: Etanercept is a selective competitor of TNF alpha which is a pro-inflammatory cytokine. It is currently used alone or in combination with other medication for the treatment of chronic inflammatory disease.

Aim: To establish the treatment effect of etanercept in acute sciatica secondary to lumbar disc herniation.

Method: Triple blind randomised controlled study. Inclusion criteria were acute unilateral radicular leg pain secondary to herniated nucleus pulposus confirmed on MRI scan. Exclusions were previous back surgery, spinal stenosis and any contraindications to the use of etanercept such as immunosuppression. The patient, the injector and assessor were blinded to the agent being used. Follow up was at 6 weeks and 3 months post treatment. Oswestry Disability Index (ODI) and Visual analogue scores (VAS) were among the assessment criteria.

Results: 15 patients were recruited in a 4 year period with a 3 month follow up of 80%. The Etanercept group had 8 patients whilst the placebo group had 7. The average ODI for the Etanercept group pre-intervention was higher than that in the placebo group (56.1 vs. 50.4) and this remained the same after 6 weeks (50.5 vs 31) and 3 months of follow up (39.2 vs. 27.3). VAS was also higher in the Etanercept group vs. placebo; pre-injection (8.5 vs. 7.4), 6 weeks (5.6 vs. 3.8), and 3 months (7.0 vs. 4.5).

Conclusion: Small numbers of trial participants limited statistical analysis. The trend appears to show no benefit to the use of Etanercept over placebo in the pharmacological treatment of sciatica.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 481 - 481
1 Sep 2009
Sell P
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Aim: To compare the outcomes and complications of an interspinous distraction device and decompression for single level spinal stenosis in the lumbar spine

Study type: Prospective comparative cohort audit of a new procedure.

Method: Prospective data was gathered on two cohorts of consecutive patients undergoing surgery for single level symptomatic lumbar spinal stenosis. The cohorts were matched for age, level of surgery and follow up. The X-Stop interspinous distraction device was compared to a standard non instrumented decompression.

There were 36 patients, 18 patients in each group, average age 66, average follow up 8 months. There was no commercial support or funding of any sort. Outcome measures were the Oswestry Disability Index (ODI), visual analogue for pain (VAS), and self perceived walking distance in yards. N.I.C.E. guidance IPG 165 was given to all interspinous distraction device patients.

Results: Pre op patient assessed walking distance in the lumbar decompression group was 152 yards; there was a 6-fold improvement to 925 yards. The interspinous distraction device had a 7 fold improvement on average, from 181 yards to 1313 yards. The improvement in ODI was most marked in the decompression group, pre surgery 61%, post surgery 29%. The interspinous group improved from 45% to 32%.

This was a clinically significant and statistically significant difference P=0.002 in favour of simple decompression. The VAS was 7.88 improving to 3.05 in the decompression group, whereas the interspinous distraction group the change was from 7.3 to 4. Complications were 3 spinous process fractures and one late migration of implant in the distraction group. There were 2 incidental durotomies and one epidural bleed greater than a litre in the decompression group. Six of the interspinous distraction devices already demonstrate lucent zones around the implant at post op follow up the significance of which is not clear.

Conclusion: There is a clinical and statistical significant difference in favour of the established procedure of lumbar decompression in terms of improvement in Oswestry Disability Index in this study. Caution with, and scrutiny of new implants and procedures is an essential component of clinical judgement and governance.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 478 - 478
1 Sep 2009
Okoro T Sell P
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Aim: To assess surgical outcomes between discectomy at the L4/5 level and L5/S1.

Introduction: There is sound biomechanical reasoning to suspect a difference might exist between spinal levels. The L4/5 disc is more susceptible to axial torsion and is the most common site of lumbar instability. The L5/S1 motion segment is protected from torsional strain by extensive iliolumbar ligaments but more exposed to axial compressive forces.1 There appears to be a difference between the L4/L5 motion segment and the L5/S1 in outcomes of disc replacement surgery. The available literature implies a difference but does not include studies with accepted standard outcome measures.

Method: 130 patients from a single centre undergoing a single level discectomy at L4/L5 or L5/S1 for radicular pain with prospectively gathered data. Oswestry disability index (ODI), subjective walking distance, Modified Somatic Perception (MSP), Modified Zung Depression Index (MZD), Low Back Outcome Score (LBOS) and visual analogue score (VAS) were collected over an average of 56 months of follow up. Comparisons between L4/5 vs. L5/S1 levels were made with these outcome measures using student’s t-testing.

Results: There were 78 L5/S1 and 52 L4/5 discectomies identified. Pre-operative walking distance for L5/S1 patients was higher at L4/5 (455m vs. 278m; p=0.027). At 6 months a small clinical difference exists with the back function scores that achieves statistical difference (47.11 (L4/5) vs. 39.47 (L5/S1); p=0.0229). Across all other parameters, no significant difference was found to exist between both groups. There was no difference in the recurrence rate or re-operation rate. There was no difference in early and late outcomes.

Conclusions: No statistically significant difference exists between surgery at the L4/5 level and the L5/S1 level in terms of post-operative outcome. There is no clinically significant difference in outcome. Planned surgical treatment strategies should not be altered by perceptions of difference in outcome when none exists.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 478 - 478
1 Sep 2009
Sell P Okoro T
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Aims: To determine outcomes in somatised patients and identify factors of clinical utility that help predict favourable and unfavourable results.

Introduction: Somatisation is a tendency to experience and express somatic distress and symptoms unaccounted for by pathological findings and to attribute them to physical illness, often with excess seeking of medical help for them. Somatised patients undergoing spinal surgery have less favourable outcomes than the normal surgical population. However a range of outcomes occur.

Methods: Prospective data from a single centre was obtained. Pre-operative modified somatic perception (MSP) and modified Zung depression (MZD) scores were available on 993 patients. The 46 patients with high somatic scores were identified as a discrete sub-group. Some patients did extremely well some patients had poor outcomes. Quantification of the number of consultants seen, outpatient clinic (OPD) reviews and duration of symptoms were compared to indicators of poor outcome (unchanged or increased visual analogue score (VAS), increased or < 10 point decrease in Oswestry disability index (ODI)) at 6 and 12 months of follow up.

Results: In the 46 patients the mean pre surgical scores were ODI 64.9 (SD 12.75) MSP 16 (SD 7.74); MZD 38 (SD 10.4); Prior to surgery they had a mean of 9.6 OPD attendances, the average number of consultants seen was 3.28 (SD 2.83). Overall the post-operative mean ODI was 36.81 (SD 24.58) a clinically satisfactory improvement. At 6 months patients who have a good outcome (ODI) had had an increased number of orthopaedic consultations (60% vs. 39.7%) but this was not statistically significant; p=0.16. At 12 months patients with a good outcome (ODI) had waited a lower number of months before surgery (5.5 vs. 11; p=0.026). Across all other parameters, including gender, age, surgical procedure undertaken, no other significant correlation exists between OPD, consultants seen and the changes in VAS, ODI at 6 and 12 months of follow up.

Conclusions: Dramatic differences exist between somatised patients who have good and poor outcome following spinal surgery. The number of months from decision to operate to surgery appears to predict good outcome at 12 months. No other identifiable pre-op factors were found.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 279 - 280
1 May 2009
Sell P Tafazal S Ng L Chaudhary N
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Objectives: To determine the treatment effect of corticosteroids in peri-radicular infiltration for radicular pain. Secondary investigations were on the requirement for subsequent interventions such as root blocks and/or surgery. A sub group analysis between sciatica and stenosis was undertaken.

Study Design: A randomised, double blind controlled trial.

Subjects: 150 eligible patients with radicular pain and unilateral chronic symptoms were randomised for a single injection with bupivacaine and methylprednisolone (b+s) or bupivacaine (b) alone.

Outcome measures: The outcome measures included the Oswestry Disability Index (ODI), Low Back Outcome Score (LBOS), Visual Analogue Score (VAS) for leg pain and back pain and patient’s subjective level of satisfaction of the outcome.

Results: 76 patients in the b only group and 74 patients in the b+s group.

Clinically useful improvements of greater than 10 points on the ODI occurred in 54%, deterioration of 10 points or more occurred in 17%. Visual analogue for leg improved by 2 or more in 63%.

There was no statistically significant difference between the groups at 3 months (change in ODI [p=0.2], change in VAS [back pain, p=0.28; leg pain, p=0.67]. Subgroup analysis revealed no statistically significant difference in the change in scores between the stenotic group and disc herniation group at 3 months. At 1 year follow-up data was available for 86% of the patients. There was no statistically significant difference in the rate of further interventions.

Conclusion: Clinical improvement occurs in both groups of patients. Corticosteroids did not provide additional benefit. There is no difference in the need for further root blocks or surgery.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 4 | Pages 517 - 521
1 Apr 2009
Okoro T Sell P

We compared a group of 46 somatised patients with a control group of 41 non-somatised patients who had undergone elective surgery to the lumbar spine in an attempt to identify pre-operative factors which could predict the outcome. In a prospective single-centre study, the Distress and Risk Assessment method consisting of a modified somatic perception questionnaire and modified Zung depression index was used pre-operatively to identify somatised patients. The type and number of consultations were correlated with functional indicators of outcome, such as the Oswestry disability index and a visual analogue score for pain in the leg after follow-up for six and 12 months.

Similar improvements in the Oswestry disability index were found in the somatised and non-somatised groups. Somatised patients who had a good outcome on the Oswestry disability index had an increased number of orthopaedic consultations (50 of 83 patients (60%) vs 29 of 73 patients (39.7%); p = 0.16) and waited less time for their surgery (5.5 months) (sd 5.26) vs 10.1 months (sd 6.29); p = 0.026). No other identifiable factors were found. A shorter wait for surgery appeared to predict a good outcome. Early review by a spinal surgeon and a reduced waiting time to surgery appear to be of particular benefit to somatised patients.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 452 - 452
1 Aug 2008
Tafazal S Ng L Sell P
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Purpose: To assess the effectiveness of nasal salmon cal-citonin in the treatment of lumbar spinal stenosis

Methods: Forty patients with symptoms of neurogenic claudication and MRI proven lumbar spinal stenosis were enrolled into the study. They were randomly assigned to either nasal salmon calcitonin 200 i.u or placebo nasal spray (sodium chloride) for the first 4 weeks. At the end of the 4 weeks of initial treatment the patients were given a 6 weeks washout period, during which they received no further nasal spray and were instructed to continue with their normal analgesics. At the end of this period all patients received a further 6 weeks of active nasal salmon calcitonin.

Outcome measures: Oswestry Disability Index (ODI), Low Back Outcome Score (LBOS), Visual Analogue Score (VAS) for leg and back pain, Shuttle Walking Test Distance in metres.

Results: In the 4 weeks during which patients received active/placebo nasal salmon calcitonin there was no statistically significant difference in the change in outcome scores between the two groups (change in ODI [p=0.51], change in VAS for leg pain [p=0.51] and change in shuttle walking distance [p=0.78]) There is a minimal improvement in the mean ODI at the end of only 3.7 points in the calcitonin group and 3.8 points in the placebo group [p=0.44]. The VAS for leg pain deteriorated in both groups. There was a minimal improvement in the VAS for back pain in the calcitonin group of 5 mm, it deteriorated in the placebo group by 11mm [p=0.03]. At the end of the trial 9 patients (23%) reported either an excellent or good outcome, 6 reported a fair outcome (15%) and 17 patients (43%) reported a poor outcome.

Conclusion: This dose of Nasal salmon calcitonin is not effective in the treatment of patients with lumbar spinal stenosis.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 490 - 490
1 Aug 2008
Sell P Buchanan E Hailey L
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Background and Purpose: There is evidence that biospychosocial information imparted to patients can be effective in reducing pain, increasing function, shifting unhelpful beliefs, and reducing healthcare utilization. The effectiveness of this information is enhanced if it is addresses the individuals concerns. Qualitative studies have identified common patient concerns, but these studies have typically been small sample sizes. The purpose of this study is to identify FAQ’s of patients presenting to secondary care in the UK, and to explore differences with regard to diagnostic category, disability, employment status and level of distress.

Methods: In excess of 500 consecutive new patients presenting to secondary care, for a specialist opinion were invited to write up to 3 questions which they would like answered in their consultation that day. In addition patients completed the battery of questionnaires normally used in these clinics (VAS (pain), ODI HAD, employment status). Post consultation each patient was assigned to a diagnostic category including non-specific LBP.

Themes from the questions were identified and discussed by two of the authors (blind to each other) using the first 50 questionnaires. The most frequently asked questions were then identified for the whole group and for subgroups determined by diagnosis, disability, employment status and distress and age.

Results: Although the most FAQ’s have been identified, there were differences between subgroups and the range of questions was large. The key themes and relationships identified will be presented.

Conclusion: Although addressing FAQ’s in patient information is to be encouraged. The findings of this study emphasize the importance of exploring and addressing individual patient concerns.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 529 - 529
1 Aug 2008
Sivan M Ashok N Tafazal S Sell P
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Aim: This study aimed at investigating the diagnostic value of local anaesthetic hip injection test to differentiate between hip and spinal pain in patients presenting with symptoms attributable to both hip and spine pathology.

Study design: Prospective cohort.

Materials and Methods: 48 patients with such diagnostic dilemma under one the care of one spinal surgeon in one centre were carefully selected. All patients had radiographs of the hip joint confirming varying degrees of osteoarthritis. Most of the patients also had different types of spinal imaging showing degenerative spinal changes. The hip injection test involved intraarticular injection of 0.5% Bupivacaine under strict aseptic precautions in a laminar airflow theatre under fluoroscopic control.

Results: 37 patients had a significant relief of pain to the injection. Of these, 33 (89%) underwent successful total hip replacement with relief of pain. The patients with a negative response to the test responded satisfactorily to treatment directed towards their spinal pathology. The sensitivity of this test is at least 97% and specificity 90%. These results are similar to those of previous studies on this topic.

Conclusion: Local anaesthetic hip injection test is a safe, inexpensive and reliable diagnostic tool in identifying the source of the pain in patients with attributable dual pathology.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 453 - 453
1 Aug 2008
Sell P Sivan M Sell B
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Purpose: To establish the results of a three week functional restoration program in terms of commonly used surgical outcome measures

Method: 135 patients ( 57 male 78 female) undertook a three week functional restoration program consisting of hydrotherapy, gymnasium work, education and cognitive behavioral therapy. They completed pre-program standard questionnaires including the Oswestry Disability Index and the Roland Morris. Follow up was at an average of 26 months (std dev 7) The patient global assessment of worse, unchanged, better and much better were completed as well as the pre-program outcome measures.

Results: Oswestry; Roland Morris

Pre program 34 average: s.d. 158.8; s.d. 4.5

Post program 19 average: s.d. 174.3; s.d. 4.8

Patient Global assessment:

Much better 64; 47%

Excellent 62; 49.6%

Better: 52; 38%

Good: 43; 34.4%

Unchanged: 2; 9%

Fair: 16 ; 2.8%

Worse: 7; 5%

Poor: 4; 3.2%

Data on the impact upon work was available for 121 of the patients. Pre program 71 of the 121 had been seriously affected in the workplace. Work follow up was 79% and at follow up only 22 out of 96 were seriously affected in the workplace. A significant improvement.

43 had an injury at work, RTA or similar significant event, 89 did not. The ODI improved by 18 points in the attributable event group and 13 in the non event group. Similar results were found for the Roland score. There was no significant difference between the two groups.

Conclusion: A very favourable results in the treatment of chronic back pain can be achieved, despite including adverse patient groups. Over 80% of patients were in the ‘success’ treatment groups at follow up using the Scandinavian Spine stabilization study group global assessment tool. Surgeons, patients and health care purchasers need to be aware of what can occur with non surgical treatment.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 525 - 525
1 Aug 2008
Spiteri V Sell P
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Purpose: A descriptive cohort study of the surgical treatment of spinal tuberculosis in a single unit in the United Kingdom

Tuberculosis is a common disorder and may be increasing in prevalence. 83 cases of spinal involvement with TB occurred and of these 40 patients had a total of 61 interventional procedures.

Indications for intervention were:

Progressive neurological deterioration

Failure to respond to treatment

Doubt about the diagnosis

Progressive deformity.

Results: The age range was from 12 to 73. Sixteen patients had 17 closed biopsies to assist in establishing the diagnosis, of these four went on require further surgical procedures. There were five intermediate level procedures such as application of halo or removal of hardware.

Two patients were Caucasian with no predisposing factors and delays occurred in the initial diagnosis. Diabetes was a significant associated co-morbidity particularly in Asian patients.

Multiple procedures were required usually for staged stabilisation after anterior decompression. 2 patients had four procedures, 2 had three procedures and 10 had two procedures 27 had a single procedure.

Nine patients that underwent anterior decompression and strut grafting for neurological deterioration went on to have a second stage extra focal fixation and became ambulant. One death occurred from mesenteric infarction at 4 months post op in this group. Significant neurological recovery occurred after surgery in the neurologically impaired patients.

Two revision procedures were required in the cervical spine for inadequate primary stabilisation.

Conclusion: About half of the spinal TB cases come to interventional procedures.

Surgery when required is often a complex decompression and staged reconstruction


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 459 - 459
1 Aug 2008
McGregor A Kerr J Burton A Waddell G Sell P
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Clinical outcomes of surgery for disc herniation and spinal stenosis are variable. Surveys show that postoperative management is inconsistent; spinal surgeons and their patients are uncertain about what best to do post-operatively. Following a focused literature review, a patient-centred, evidence-based booklet was developed, which aims to reduce uncertainty, guide post-operative management and facilitate recovery. Initial peer and patient evaluations were encouraging and the booklet Your back operation (www.tso.co.uk/bookshop) is currently factored into a trial investigating the post-operative management of spinal patients.

To date, 80 patients have been recruited into the study of which 34 have been randomised to receive the booklet. At 6 months post-surgery all of these patients are requested to complete a questionnaire on the booklet. This questionnaire contained forced-choice questions on readability, style, information level, believability, length, content and helpfulness. Further open questions concern the booklet’s messages, giving patients the opportunity to identify anything they did not like or understand, voice any concerns that were not covered, and say if they thought the booklet would change what they did after surgery. Finally, they were asked their overall rating of the booklet on a scale from 1 to 10.

Feedback is very positive. The average overall rating of the booklet was 8.6/10. Over 80% found it easy to read, interesting, and of appropriate length. Over 80% also stated they had learnt new and helpful information. All subjects stated that they would recommend the booklet to a friend, and the majority stated that they frequently referred to the booklet. The predominant messages received and understood by the patients were related to the safe benefits of early activation and return to normal activities.

The results show that spinal surgery patients appreciate evidence-based information in booklet form, and suggest that this booklet may be an important adjunct to post-operative management of spinal patients.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 525 - 525
1 Aug 2008
Braybrooke J Sell P
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Revision discetomy is a procedure often assumed to give similar results to primary discectomy. There is no level one or level two evidence to support this view and no publications with pre and post surgical spine specific outcome measures.

This aim of this study was to evaluate the surgical outcomes of revision discectomies using standard spine instruments and to identify factors which influence the outcome. A prospective cohort study was performed between 1996 and 2004. A revision discectomy was defined as surgery at the same lumbar level as a previous discectomy with a minimum three month interval from the index surgery. Outcome measures were available for all 20 patients from the index primary discectomy. Questionnaires were given to the patients preoperatively and at 2 year follow-up. Among the outcomes measures used were the Oswestry Disability Index (ODI), the Low Back Outcome(LBO), and a Visual Analogue Score(VAS). 20 revision discectomies were performed on 11 males and 9 females, 7 at L4/5 and 13 at L5/S1. The mean age was 41(30–56) and the mean follow-up was 27(24–36) months. The preoperative ODI, LBO and VAS at the index primary discectomy averaged 54(22–82), 19(7–42) and 8(5–10) respectively. The preoperative ODI, LBO and VAS at the revision discectomy averaged 63(34–82), 18(1–46) and 8(1–10) respectively. The ODI, LBO and VAS all improved significantly at follow-up. The ODI averaged 27(2–66) (p< 0.05), the LBO averaged 47 (14–70) (p< 0.05) and the VAS 4(3–9) (p< 0.05). The outcome of revision discectomies is favourable, in this series the average improvement in ODI was 36 points, a clinically significant change. The risk factors which influence the outcome are preoperative ODI, preoperative VAS and Age (p< 0.05). Sex, preoperative LBO, duration between recurrent disc herniation, level of disc herniation and incidental durotomies were not predictive of outcome.


Objective: To determine if there was any difference in standard spine outcome measures for single level degenerative lumbar spondylolisthesis treated by decompression and intertransverse fusion alone or with pedicle screw instrumentation.

Methods: A prospective longitudinal cohort study was undertaken looking at 23 patients undergoing surgery for L4/5 degenerative spondylolisthesis with symptomatic spinal stenosis. Clinical outcome was assessed through specific outcome measures of walking distance(yards), Oswestry disability index (ODI), Back Functional Assessment (BFA) and Visual analogue score for pain(VAS).

Results: Follow up was achieved in 21 patients (91%) and the mean length of follow up was 29 months (range 12–60 months). The mean age at operation was 66 years. In the uninstrumented group (n=12), the mean pre and post operative outcome scores were: walking distance (pre-122, post-950), ODI (pre-45, post-29), BFA (pre-23, post-31) and VAS (pre-83, post 49). In the instrumented group (n=11), the mean pre- and post operative outcome scores were: walking distance (pre-143, post-763), ODI (pre-54, post-33), BFA (pre-14, post 33) and VAS (pre-77, post-49). There was no statistically significant difference in improvement in each outcome measure between the two groups.

Conclusion: Surgical decompression in degenerative spondylolisthesis aims to relieve symptoms of radicular pain and neurogenic claudication. However, the indications for instrumentation are controversial. Previous studies have shown an improved fusion rate with instrumentation but no difference in subjective patient satisfaction scores. We have used validated patient based outcome measures to assess clinical outcome. Our results show no statistically significant difference between single level L4/5 degenerative spondylolisthesis treated with decompression with or without instrumentation.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 476 - 476
1 Aug 2008
Grevitt M Fagan D Al-Khayer A Sell P
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Type of study: Case-series comparison.

Patients: 20 patients (2 males); average age 15.5 years; mean follow-up 22 months. 10 patients (Lenke type 1) had anterior correction and instrumentation; 10 patients (Lenke type 2) had posterior operations. All patients had a selective thoracic fusion (with the type 2 curves having instrumentation incorporating the proximal thoracic curve).

Outcome measures: Complications, radiological parameters (Cobb correction of major & compensatory curves); trunk shape (rib hump / scoliometer), and SRS-22 questionnaires.

SRS-22 outcomes: There was no significant difference in the pre-operative individual domain scores (pain, self-image, function, mental health, satisfaction) between the two groups. There were no differences in the postoperative results (including self-image) apart from pain. The anterior surgery group had more persistent pain, but at a similar level than preoperatively (3.2 [0.8] vs 4.6 [0.3], p~0.03).

Conclusion: For right thoracic (Lenke curve types 1& 2) late-onset idiopathic scoliosis both types of surgery deliver similar radiological and trunk-shape results. SRS-22 self-image and function post-operative results are also similar. The anterior procedure did not however improve the pre-operative pain score.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_II | Pages 217 - 217
1 Jul 2008
McGregor A Burton A Waddell G Sell P
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Background/purpose: Clinical outcomes of surgery for disc herniation and spinal stenosis are variable. Surveys show that post-operative management is inconsistent, and spinal surgeons and their patients are uncertain about what best to do during the recovery phase. The aim of this study was to develop a patient-centred, evidence-based booklet that spinal surgeons can give to their patients to reduce uncertainty, guide post-operative management and facilitate recovery.

Methods: A systematic literature search led to a best-evidence synthesis of appropriate information and advice on post-operative activation, restrictions, rehabilitation, and expectations about surgical and functional outcomes. Data were extracted into evidence statements which were graded by consensus for consistency and practicality so as to inform and prioritise the booklet’s messages. Following peer review (n = 16), a sample of patients (n = 11) gave a structured evaluation of the draft text.

Results: The review found scant evidence in favour of post-operative activity restriction, yet an early active approach to post-operative rehabilitation can improve clinical, functional and occupational outcomes. Thus, the text of the booklet presents carefully selected messages to reduce uncertainty, promote positive beliefs, encourage early reactivation, and provide practical advice to aid self-management. Peer reviewers’ comments were incorporated into the text; all the spinal surgeons (n = 7) said they would find the booklet useful. Patients found it readable, interesting and helpful; they understood and accepted the intended messages.

Conclusions: Following careful development, an evidence-based booklet to aid post-operative management in spinal surgery is now available, and is factored into a RCT of post-surgical rehabilitation.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 15 - 15
1 Mar 2008
Ng L Sell P
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To evaluate prognostic factors that influence outcome particularly those related to duration of symptoms in surgery for lumbar radiculopathy, #2

In primary care 75% of patients are pain free after the onset of sciatica within 28 days. The optimum timing of surgery for unresolved leg pain secondary to herniated lumbar disc is unclear.

#2 We prospectively recruited 113 patients in this study and at one year, the follow up was available on 103 (91%). We investigated the prognostic value of a number of variables. These included the duration of sciatic symptoms, age at operation, Modified Zung Depression Score (MZD) and Modified Somatic Perception Score (MSP) using multiple regression analysis. The outcome was measured by the change of the Oswestry Disability Index (ODI), Low Back Outcome Score (LBOS) and of the Visual Analogue Scale (VAS). Patients with contained and non-contained herniated disc were compared.

The change in ODI is statistically significantly associated with the duration of sciatica symptoms (p=0.05) with a one-month increase in the duration of symptoms being associated with a decrease in the change of ODI of 0.6% (95% CI, −1.014 to −0.187). The duration of sciatica and the MZD are associated with significant reduction in LBOS (p=0.034 and 0.028 respectively). VAS was not significantly associated with all the prognostic factors investigated.

A shorter duration of sciatic symptoms was associated with a greater degree of patients’ outcome satisfaction. Non-contained herniated disc had a shorter duration of symptoms and a better functional outcome compared to contained herniated disc. Unemployment and smoking were not risk factors for poor surgical outcome.

Conclusion: Our study indicates that the duration of radicular pain of more than 12 months has a less favourable outcome. Patient’s satisfaction is greatest if surgery occurs within one year.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 220 - 220
1 May 2006
Tafazal S Sell P
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Introduction: Lumbar spinal stenosis commonly affects elderly patients with multiple co-morbidities. They are at increased risk of complications following surgical interventions. Non-operative strategies for treating them are desirable and previous studies have shown some benefit of subcutaneous salmon calcitonin for the treatment of spinal stenosis.

Objectives: To assess the effectiveness of nasal salmon calcitonin for the treatment of lumbar spinal stenosis in a cohort of patients.

Study design: Prospective cohort study

Methods: 34 patients with MRI proven lumbar spinal stenosis were enrolled into the trial. They received salmon calcitonin in the form of a nasal spray for 6 weeks. All the patients had multiple co-morbidities making them high risk for any surgical intervention. They were followed up at 6 weeks and at 12 weeks. The main outcome measures were oswestry disability index (ODI), low back outcome score (LBOS) and visual analogue scale (VAS). The patient’s were also subjectively asked to rate the treatment excellent, good, fair or poor.

Results: The mean age was 73.5 years (range 51–92 years). The mean duration of symptoms was 32.6 months (range 3–120 months) The mean ODI pre-treatment was 50 and after 6 weeks of treatment decreased to 47 (p=0.14). The mean LBOS was 18 pre-treatment and increased to 21 (p=0.02) after 6 weeks of treatment. The mean VAS for leg pain was 76mm pre-treatment and decreased to 64mm (p=0.001) after treatment and the mean VAS for back pain only decreased from 64mm to 61mm (p=0.5). 11 patients (32%) had a minimum 20mm change in VAS scores after treatment and 7 patients (21%) improved their ODI score by a minimum of 10 points. All results remained stable at 12 weeks follow-up, suggesting a longer effect than the duration of treatment. With regards to patient’s subjective outcome 9 patients (27%) rated the treatment as fair, 3 rated it as good (9%) and 17 reported no change (50%).

Conclusion: Our results suggest the benefits of nasal salmon calcitonin treatment are marginal, with a minimal improvement in symptoms of patients with lumbar spinal stenosis.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 221 - 221
1 May 2006
Tafazal S Sell P
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Objectives: To assess the outcome of patients undergoing anterior lumbar interbody fusion with the Hartshill Horseshoe cage device.

Study Design: Prospective cohort of patients from a single centre in the UK

Methods: 20 patients underwent anterior lumbar inter-body fusion from September 1994 to November 2002. All patients underwent primary anterior fusion alone. The diagnosis was back pain alone in 10 patients, instability and back pain post discectomy in 9 patients and pseudoarthrosis in the remaining patient. The main outcome measures were oswestry disability index, low back outcome score, visual analogue scale for back and leg pain, modified somatic perception and modified zung depression score.

Results: Follow-up data was available for 17 patients at two years (85%). There were 11 females and 9 males and there average age at operation was 39 years (range 30–50 years). The mean ODI pre-op was 56 and this improved to 30 post-op (p=0.004). The mean LBOS pre-op was 21 and this improved to 41 post-op (p=0.005). The VAS pre-op was 83mm and improved to 48mm postop (p=0.01). Overall 13 of the patients (76%) improved their ODI by a minimum of 10 points. When comparing the groups according to diagnosis, the patients with back pain alone had a 17 point improvement in ODI whereas the patients with back pain post discectomy had a 29 point improvement in ODI (p=0.33). The main complication of surgery was common iliac vein tear occurring in two patients which was repaired intra-operatively.

Conclusion: Anterior lumbar interbody fusion using the Hartshill horseshoe cage device is a safe and effective method of achieving spine stabilisation in patients with back pain. It seems to be particularly effective for those patients who have instability and back pain post-discectomy.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 11 - 11
1 Mar 2006
Sell P
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Whiplash associated Disorder is a clinical entity that is well recognised by doctors patients and the legal profession. It is however a clinical syndrome that has few of the characteristics that are normally associated with the epidemiology and pathology of injury.

The dilemma of Whiplash is the absence of hard evidence of any pathological process that would normally be considered evidence of a disease process.

Epidemiology exposes some of the gaps in the current models of whiplash. There are unexplained cultural variations. The different legal mechanisms of claim should not influence a physical traumatic disorder.

There is normally a clear relationship between the kinetic energy involved in injury and the tissue disruption that occurs. Experimental models using crash tests produce conflicting results. Studies of polytrauma reveal a very low incidence of post traumatic neck pain.

A range of opinions are available in the literature on pathology and biomechanical factors. Systematic analysis reveals the level of evidence for the establishment of the disease of whiplash in the 1960’s to be level two or three, while the evidence for discarding whiplash as a physical disease in the modern literature is level one or two. It is much harder for physicians to discard a cultural fixed belief in a disease that may never have existed rather than to accept the verifiable logic of modern models of disease.

Various historical arguments that have been used to support a physical basis for whiplash associated disorder have a flawed logic. The current best evidence would suggest that the acute phase of a whiplash disorder may be the result of a minor soft tissue injury, the natural history of which is recovery. There is little or no evidence to support a physical basis for chronic symptoms, which on the balance of probability are due to psychosocial factors. Whiplash is a ‘convenient’ model of illness which results in ‘gain’ for all those involved in its manifestations. It is a convenient disease.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 242 - 242
1 Sep 2005
Fafaxal S Sell P
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Study design: Prospective longitudinal cohort study with two-year follow up.

Objective: To define the standard outcome measures that describe a patient’s subjective outcome following elective spinal surgery. What constitutes a clinically important change in outcome is not well understood and few studies have addressed this issue.

Subjects: 193 patients undergoing elective spinal surgery (110 discectomy, 72 spinal decompressions and 11 other procedures) Average age 48 years.

Outcome measures: Oswestry disability index (ODI), Low back outcome score (LBO), Visual analogue score (VAS) and patient subjective assessment of outcome as Excellent, Good, Fair and Poor.

Results: There were 100 Excellent results, ODI 54 pre and 19 post. 62 Good results ODI 53 pre and 29 post. The 18 Fair results started with an ODI of 63 and improved to 51. The 13 Poor results started with an ODI of 66 and ended with 61. Similar changes occurred in VAS and Low back outcome score. An excellent outcome for discetomy, ODI reducing from 57 to 13 was different to an excellent outcome for a decompression, where the ODI changed from 54 to 26.

Conclusion: Generic spinal outcome scores are the current measurement tool of clinical change. Clinically significant change as perceived by the patient may be different for different conditions. Only a Poor outcome was associated with an ODI change of less than 10 points.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 243 - 243
1 Sep 2005
Sell P
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Study design: Prospective longitudinal cohort study with three month and one year follow up.

Objective: To determine what factors influence standard spine and urinary outcome measures at 3 months in cauda equine syndrome with particular attention being given to timing of onset of symptoms and timing of surgery.

Subjects: There were 31 cases submitted from the membership of BASS who underwent urgent surgery for cauda equina syndrome. Three month follow up was achieved in 25 (80%).

Outcome measures: Oswestry disability index (ODI), Visual analogue score for leg pain, Visual analogue score for back pain and incontinence questionnaire using a short form MRC outcome tool.

Results: The average age was 43 years. Ten patients had surgery within 48 hours of onset of symptoms, the remainder had more than 48 hours to surgery. Most patients received prompt attention after reaching secondary care with only four waiting more than 24 hours for surgery after scanning. There was no difference in ODI. VAS leg and back were better in the less than 48 hours group. Urinary symptoms and satisfaction did not appear to be influenced by surgery within 48 hours.

Conclusion: The duration of symptoms prior to surgery does not appear to influence the short-term outcome as measured by the Oswestry Disability Index and specific questions related to satisfaction with urinary outcome measures.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 243 - 243
1 Sep 2005
Ng L Chaudhary N Sell P
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Study Design: A randomized, double blind controlled trial.

Objectives: Various studies have examined the therapeutic value of peri-radicular infiltration using treatment agents consisting of local anaesthetic and corticosteroids for radicular pain. The main objective is to determine the treatment effect of corticosteroids in peri-radicular infiltration for radicular pain. We also examined prognostic factors in relation to the outcome of the procedure.

Subjects: Eligible patients with radicular pain who had unilateral symptoms who failed conservative management were randomised for a single injection with bupivicaine and methylprednisolone (b+s) or bupivicaine (b) only.

Outcome measures: Oswestry Disability Index (ODI), Visual Analogue Score (VAS) for back pain and leg pain, claudication walking distance and patient’s subjective level of satisfaction of the outcome.

Results: We recruited 43 patients in the b+s group and 43 patients in the b only group. The follow up rate is 100%. There is no statistically significant difference in the outcome measures between the groups at 3 months (change of the ODI [p=0.7], change in VAS [back pain, p=0.68; leg pain, p=0.94], change in walking distance [p=0.7]). No statistical difference in the change in VAS score between stenotic group and disc herniation group at 3 months. Further subgroup analysis also showed no difference in the outcome between contained and non-contained herniation group.

Conclusion: Clinical improvement occurs in both groups of patients. Corticosteroid did not provide additional benefit.


Study design: Prospective cohort study.

Objective: Despite wide acceptance of decompression surgery for spinal stenosis, the reported success rates remain variable. Our aim is to investigate the value of various predictors of functional outcome in patients undergoing primary lumbar decompression surgery secondary to degenerative spinal stenosis.

Subjects: Eligible patients who had primary posterior lumbar decompression surgery for degenerative spinal stenosis with follow up for 2 years.

Outcome measures: Oswestry Disability index (ODI), Low Back Outcome Score (LBOS), Visual Analogue Score (VAS), claudication walking distance and patient’s subjective assessment of the outcome of the surgery.

Results: Ninety-nine patients who had primary lumbar decompression surgery were recruited between July 1994 and December 2001. The follow up rate was 100% at one year and 76% at two years. There is a statistical significant association between duration of symptoms and the change in ODI, change in LBOS, change in VAS and change in walking distance both at one year and two years follow up. One-way analysis of variance also showed that the groups of patients with symptoms less than 33 months have a much better functional outcome at two years follow up. We have not found modified somatic perception score, modified zung depression score and gender to influence the outcome of the surgery.

Conclusion: This study indicates that patients with a prolonged duration of symptoms have a less favourable functional outcome. Patient’s satisfaction is greatest if surgery occurs within 33 months.