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The Bone & Joint Journal
Vol. 97-B, Issue 10 | Pages 1395 - 1404
1 Oct 2015
Lingutla KK Pollock R Benomran E Purushothaman B Kasis A Bhatia CK Krishna M Friesem T

The aim of this study was to determine whether obesity affects pain, surgical and functional outcomes following lumbar spinal fusion for low back pain (LBP).

A systematic literature review and meta-analysis was made of those studies that compared the outcome of lumbar spinal fusion for LBP in obese and non-obese patients. A total of 17 studies were included in the meta-analysis. There was no difference in the pain and functional outcomes. Lumbar spinal fusion in the obese patient resulted in a statistically significantly greater intra-operative blood loss (weighted mean difference: 54.04 ml; 95% confidence interval (CI) 15.08 to 93.00; n = 112; p = 0.007) more complications (odds ratio: 1.91; 95% CI 1.68 to 2.18; n = 43858; p < 0.001) and longer duration of surgery (25.75 mins; 95% CI 15.61 to 35.90; n = 258; p < 0.001). Obese patients have greater intra-operative blood loss, more complications and longer duration of surgery but pain and functional outcome are similar to non-obese patients. Based on these results, obesity is not a contraindication to lumbar spinal fusion.

Cite this article: Bone Joint J 2015;97-B:1395–1404.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 99 - 99
1 Sep 2012
Lakkol S Taranu R Reddy G Chandra B Friesem T
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Background

The factors that are considered to be associated with successful clinical outcome fallowing cervical arthroplasty surgery are patient selection, absence of facet joint changes and lack of pre-operative kyphosis. Even though many studies have cited the pre-operative demographic details of their patient groups, the effect of associated psychological co-morbidities (Depression/Anxiety), smoking history, gender, social benefits and employment status on the clinical outcome measures have not been reported. The aim of the study was to assess the influence of pre-operative patient characteristics on the clinical outcomes following cervical disc replacement.

Methods

We included 126 patients who underwent single or multiple level cervical arthroplasty in our unit were included in the study. The clinical outcome measures such as Visual Analogue Score for neck pain (VAS-NP) and arm pain (VAS-AP); Neck disability Index (NDI), Hospital depression and anxiety scale and Bodily pain component of Short Form 36 questionnaires (SF-36 P) were recorded pre and post operatively. Statistical analysis was completed using SPSS 16.0 statistical package (SPSS Inc, Chicago, IL).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 278 - 278
1 Sep 2012
Aranganathan S Aranganathan S Lakkol S Taranu R Reddy G Friesem T Kang J
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Introduction

The implantation of DIAM in interspinous space is believed to act as facet joints and provides stability to operated segment by shifting instantaneous axis of rotation forward in lordotic disorders. In this retrospective study, the patients who underwent lumbar surgery with DIAM (Medtronic Sofamor, Danek) spacer implants were followed up with an aim to evaluate the clinical outcomes. To our knowledge, this is the largest series with longest follow up.

Material Methods

Patients who underwent lumbar surgery (discectomy and decompression) with concomitant placement of DIAM spacer within a 36-months period were included. A total of 52 patients including equal number of male (n=26) and female (n=26), were followed up for 12 to 45 months (Mean: 22 months).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 100 - 100
1 Sep 2012
Lakkol S Aranganathan S Reddy G Taranu R Friesem T
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Introduction

In the last decade, single level cervical arthroplasty has proven its efficacy as one of the surgical treatment option for for patients suffering from cervical degenerative disc disease. Recent published reports on multilevel cervical arthroplasty using single implants have shown statistically significant results when compared to single level surgery. The aim of this study is to compare the clinical outcomes of multilevel cervical arthroplasty to single level cervical arthroplasty, when more than one type of implants were used.

Methods

This is a prospective study of consecutive patients who presented to our unit in between June 2006 and November 2009. The maximum follow-up period was 51 months (mean=18 months). Several types of cervical arthroplasty devices have been used in this study. The clinical outcome measures such as Visual Analogue Score for neck pain (VAS-NP) and arm pain (VAS-AP); Neck disability Index (NDI) and the Bodily pain component of Short Form 36 questionnaires were recorded pre and post operatively. After confirming the normality of the data appropriate parametric (paired t-test) were used to assess the statistical significance (p< 0.05) between pre and post-operative values. Two sample T-test was used to assess the significance between the differences in mean scores between each group.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 6 - 6
1 Jun 2012
Taranu R Lakkol S Aranganathan S Bhatia CK Reddy G Friesem T
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Introduction

This study aims to evaluate the impact of associated psychological co-morbidities (Depression/Anxiety), smoking history, gender, work benefits and employment status on the clinical outcome following anterior cervical disc replacement (ACDR).

Materials and Methods

We included in our study 100 patients who underwent ACDR in our Spinal Unit (between May 2006 – May 2010). We used as clinical outcome measures: Visual Analogue Score for neck pain (VAS-NP) and arm pain (VAS-AP), Neck Disability Index (NDI) and Bodily Pain (SF36-BP) component of the Short Form 36 questionnaire. Statistics were obtained using SPSS 16.0 for Windows (SPSS Inc, Chicago, IL). Independent sample t-test for normally distributed data and Man-Whitney U test for non-parametric data were used. Statistical significance was designated at p < 0.05.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 89 - 89
1 Jun 2012
Lakkol S Lingutla K Taranu R Kang J Reddy G Friesem T
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Background

We present the results of a single centre, prospective study to evaluate the clinical and radiographic outcomes of anterior cervical decompression and replacement (ACDR) using the NuNec(tm) Cervical Arthroplasty System (Pioneer Surgical Technology, Marquette, Mich., USA).

Methodology and Results

36 patients with radiculopathy/myelopathy, who failed to respond to conservative measures, were included. Pain and function were evaluated by Visual Analogue score for Neck pain (VAS-NP) and Arm pain (VAS-AP), Neck disability index (NDI) and SF-36 questionnaires. Radiological assessments include assessing overall range of movement (ROM) and at functional segment unit (FSU). Statistical analysis was completed using SPSS 16.0 statistical package (SPSS Inc, Chicago, IL). Appropriate parametric (A paired t-test) and non parametric tests (Wilcoxon signed-rank test) were used to assess the statistical significance (p<0.05).

The average age at operation was 51 years (range 35 - 77years). 8 patients received ACDR at one-level, 15 had 2-level surgery, 12 had 3-level surgery and 1 had a 4-level surgery. At the time of final follow-up (Mean 14.25 months, Range 12- 22.5 months) the mean NDI improved from 49.35; to 33.78 (p< 0.001). There statistically significant improvement note in VAS-NP (Post-op3.65, Pre-op:8.16, p<0.001), VAS-AP (Post-op:3.12, Pre-op:7.32, p<0.001) and SF-36BP (pre-op:29.15, post-op:37.18, p<0.002). The overall global ROM movement was preserved (pre-op:46.80±10.52, post-op:45.04±11.53) and an improvement in ROM at FSU was observed (pre-op:16.60±8.50, post-op:20.22±12.22) at final follow–up.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 90 - 90
1 Jun 2012
Lakkol S Taranu R Raju P Trewhella M Dennis R Reddy G Friesem T
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Aim

The purpose of this study is to compare the pre and post-operative magnetic resonance image clarity of titanium and PEEK based cervical arthroplasty devices at the level of implantation and adjacent level discs.

Methodology and Results

This is a prospective, blinded, randomised study on imaging of cervical arthroplasty devices. The pre and postoperative MRI images of 16 patients who underwent cervical arthroplasty using Prestige LP(r) (Medtronic Sofamor Danek) and NuNec(tm) Cervical Arthroplasty System (Pioneer Surgical Technology, Marquette, Mich., USA) were assessed. Two independent radiologists who were blinded and provided with a sets of random images to score using a four point Jarvick grading system. Statistical analysis was completed using SPSS 16.0 statistical package (SPSS Inc, Chicago, IL) and analysis included comparing MR image quality before and after cervical arthroplasty at the operated and adjacent levels, and in between two types of implant.

The pre-operative MR image quality at operated and adjacent levels was excellent in both groups. In the post-operative images, the adjacent level visualisation was adequate in both groups without much difference in average scores. However, at operated level, the quality of MR images in the NuNec group (PEEK on PEEK articulating disc) was excellent and clear visualisation of the cord, central canal, foramen and disc.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 148 - 148
1 Apr 2012
Lakkol S Bhatnagar S Lashmipathy R Reddy G Friesem T
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To assess the clinical and radiological outcome of single and multiple level Anterior Cervical Disc Replacement (ACDR) using Peek-on-peek system. We present the largest series of POPCDR at a single centre.

Thirty-one patients with radiculopathy and/or myelopathy caused by disc generation who did not respond to conservative treatments were included. Pain and function were evaluated by VAS (Visual Analogue Score) for neck (VAS-NP) and arm pain (VAS-AP). Neck disability index (NDI) and SF-36 questionnaires were completed. Disc height and segmental angular correction (SAC) were measured on radiographs pre- and postoperatively.

Seven patients had one-level, fifteen had two-level, seven had three-level and two had four-level ACDR. Sixty-six discs were replaced. Average follow-up was six months.

Mean VAS-NP improved from 7.27 to 3.93 and VAS-AP from 7.27 to 3.4. Mean SF-36 improved from 32.21 to 40.22. There was functional improvement for NDI in all patients.

There was an improvement in SAC from 5.4° to 8.0° for one-level, 3.1° to 7.5° for two level, 8.4° to 9.4° for three-level and 5.8° to 26.7° for four-level ACDR.

Post-operative anterior disc height increased by 152% for lower and 55% for higher levels. Similar improvements were noted for posterior disc heights.

Early results show that POPCDR is safe and effective for treatment of symptomatic cervical disc disease. The clinical and radiological outcomes are similar to other types of ACDR reported in literature. POPCDR also allows safe use of MRI during follow-up with fewer artifacts giving it an edge over other systems.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 194 - 194
1 May 2011
Kasis A Taranu R Marshman L Friesem T
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Introduction: There is an increasing interest in the concept of motion preservation in cervical disc degeneration surgery. There is still a controversy regarding the effect of posterior placement of the disc on the segmental motion of the treated level.

The objective of this study is to assess the effect (if any) of posterior placement of the LP Prestige disc on the motion.

To our knowledge this is the first study to assess the relation of posterior placement on the motion.

Material and Methods: We retrospectively reviewed 186 prosthesis implanted in 130 patients who underwent an LP Prestige cervical disc replacement and decompression. The distance between the posterior edge of the lower plate of the LP Prestige disc and the posterior wall of the corresponding vertebra was measured. The measurement was performed on a digitalized lateral view x-rays. The posterior placement measurement was correlated to the range of motion of the device on the same level and also on the level above and bellow.

Results: The average age was 46.7 years (range 33–66). The mean posterior placement was 2.96 mm (range 0–6 mm). Range of motion (full flexion to full extension) of the prosthesis was 9.41 degrees (range 0.2–22). Average followup was 2.3 years.

Statistical analysis showed no statistical significant correlation between the posterior placement of the disc and the motion of disc (flexion to extension, flexion to neural and neutral to extension). The p value was 0.259, 0.379 and 0.623 respectively. There was no correlation between the placement of the disc and the motion of the level above and bellow the operated level.

Conclusion: We conclude from our study that there is no correlation between the posterior placement of the Prestige LP and the segmental motion of the prosthesis and the level above and bellow.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 194 - 194
1 May 2011
Kasis A Taranu R Marshman L Friesem T
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Introduction: Cervical disc replacement has emerged as an alternative to the gold standard ACDF in ordered to preserve the motion of the cervical spine, and reduce the risk of adjacent degenerative changes. However, little data actually exists to support or refute the effect of symptoms chronicity on TDA for the treatment of degenerative cervical spine.

Material and Methods: We prospectively investigated 130 consecutive patients who have undergone a Prestige LP cervical disc replacement for degenerative disease causing chronic neck pain and radiculopathy.

The pre and post-operative NDI, SF-36, Visual Analogue Score (VAS), HDS and HAS were recorded.

Results: There were 130 patients in total. There were 66 males and 64 females, with an mean age at surgery was 51.12 +/− 0.84. Seventy five patients had one level disc replacement, and 56 had 2 levels.

The mean follow up was 28+/−0.35 months, and the mean duration of symptoms was 34.46 +/−3.8 months. Mean length of stay 1.75+/−0.11 (1–4)

There was no correlation between the DOS and any of the functional outcome:

Improvement Neck disability index (r=−0.181, p=0.134)

Improvement in HDS (r=−0.126, p=0.296)

Improvement in HAS (r=0.00, p=0.99)

Improvement in SF-36 bodily pain (r=−0.011, p=0.925)

Improvement in SF-26 mental health (r=0.042, p=0.324)

Improvement in VAS neck pain (r=−0.0120, p=0.324)

Improvement in VAS arm pain (r=0.0178, p=0.141)

Dividing the DOS into more or less than 12 months shows significant improvement only in the NDI: less than 12 months DOS (31.85±3.209) and in patients with more than 12 months DOS (19.71±2.164), p=0.002

While there was no statistical difference in the other outcomes.

Dividing the DOS into more or less than 24 months showed significant improvement the out come in patients with less than 24 months in the following outcomes:

Improvement in NDI: less than 24 months (27.35±2.714), more thank 24 months (19.72+2.435), p=0.04

Improvement in VAS arm pain: less than 24 months (4.6000±0.34446), more than 24 months (2.7414±3.7236), p=0.001

Improvement in hospital depression score: less than 24 months (5.37±0.589), more than 24 months (3.60±0.47), p-0.023

Improvement in hospital anxiety score: less than 24 months (4.28±0.49), more than 24 months (2.45±0.48), p=0.009

While there was no significant difference in the other outcomes

Dividing the DOS into less or more than 36 months showed no statistical difference in any of the outcome,

That was also the case when the DOS was divided into more or less than 48 months.

Conclusion: Duration of symptoms of more that 24 months was associated with less favorable outcome, that was evident in improvement in NDI, HDS, HAS and VAS arm pain. Patients should be counseled when they present with DOS more than 24 months.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 383 - 384
1 Jul 2010
Hadgaonkar S Kasis A Reddy G Bhatia C Hernandez M Krishna M Friesem T
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Purpose: To assess the outcomes in consecutive 32 patients of two level cervical disc replacement

Methods: In this article, we report 2-year results of anterior cervical decompression and two level cervical disc replacements (prestige) in 32 patients with a diagnosis of symptomatic cervical spondylosis. Dynamic assessment with lateral radiographs of the cervical spine in flexion/extension was done pre and post op. All of them had partial uni/bilateral uncinectomy, which adds in lateral bending. The median age of all patients was 46 years (range 32–61). Levels of surgery included between seven C3–C7, most common were C5–6, C6–7.

Results: Neck and arm pain as well as disability scores (VAS, ODI and SF36) were significantly improved by 3 months and remained improved at 2 years. Radiography revealed the complete motion (From flexion to extension) at upper disc replacement level of 11% and 9.6% at the lower level. There is a significant decrease of the facet joint articulation overlap in the sagittal plane. As the diameter of socket is slightly larger than the ball in prestige disc replacement, it helps in additional axial movement. There was reduction in motion at the adjacent segments above and below, preventing adjacent segment problems.

Conclusion: Twenty-four months after surgery, patients who underwent two level cervical disc replacements demonstrated greater improvement in neurologic function and neck pain. It helps in restoring sagittal balance, functional outcome of patient because of increased lateral bending, axial rotations and flexion-extension.

Ethics approval: done from appropriate authorities

Interest Statement: There is no local grant, national grant, commercial/industry support for this article. There are no interest or gain from any source for this article.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 69 - 69
1 Mar 2009
Budithi S Pollock R Friesem T
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Study Design: Prospective analysis of a cohort of patients who underwent a Spinal Fitness Exercise Program in a nurse led spinal assessment clinic in a University Hospital.

Objective: To determine if psychological status affects the outcome of a spinal fitness exercise program in patients with low back pain.

Background: Evidence for the effectiveness of exercise programs in the treatment of chronic mechanical low back pain is well documented. In this study, the effect of psychological status on the outcome of a self-help spinal fitness exercise programme was studied.

Methods: Patients who were referred by their primary care physicians to the nurse led spinal assessment clinic and met the inclusion criteria were given a spinal exercise booklet, which describes with the aid of diagrams how to perform a series of lumbar core stability exercises for them to practise at home. Back pain related disability was assessed before and 3 months after the exercise program using the Oswestry Disability Index (ODI). Psychological status was measured using the Distress and Risk Assessment Method (DRAM). This classifies patients into 4 groups based on the combination of scores from the Modified Somatic Perception Questionnaire (MSPQ, 13 questions, scored 0–13) and Modified Zung Questionnaire (23 questions scored 0–69): normal, at risk, distressed somatic and distressed depressive.

Results: Forty one patients were enrolled into the study (19 male, 22 female, mean age at treatment 45.8 years, age range 22–78 years). The DRAM scores showed that 9 had no psychological disturbance (normal), 17 were at risk, 4 were distressed somatic and 11 distressed depressive. Even though there was a statistically significant improvement in the mean ODI after the exercise program for all DRAM groups, the improvement in the ODI was not significantly different between the four groups (ANOVA, p = 0.596).

Conclusions: Our study suggests that the outcome of a spinal fitness exercise programme is not affected by the psychological status of the patient. We conclude that patients should not be excluded from spinal fitness exercise programs on the basis of psychological status.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 518 - 518
1 Aug 2008
Barzilay Y Pollock R Friesem T Reddy G
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Purposes: To determine the effect of gravity on outcome in sacral epidurals injected in the prone compared to the lateral position in patients with unilateral back related leg pain.

Methods: A randomised controlled trial with 2 arms. This pilot study was conducted to determine the standard deviation (SD) of the primary outcome measure to allow calculation of a final sample size. Forty patients who met the inclusion/exclusion criteria were randomly allocated to prone or lateral sacral epidural injection. Twenty patients were allocated to the prone and 20 to the left or right lateral position dependent on their radicular back pain. The primary outcome measure of back and leg pain severity was assessed using a visual analogue scale (VAS) (0= none, 10 = worst imaginable). The Oswestry disability index, SF-36 and straight leg raise were also measured. Outcomes were assessed at baseline and at 6 and 12 week follow-up. A repeated measures analysis using mixed model methodology was used to determine statistical significance.

Results: The 2 groups were comparable in gender and age. The prone group had a mean improvement in VAS back pain score at 6 weeks follow-up of 0.5 compared to 1.6 in the lateral group. At 12 weeks follow-up there was a negative response of 0.1 compared to baseline in the prone group and 1.4 improvement in the lateral group. Repeated measures analysis showed no significant difference in back pain scores between the groups at the 5% level (F2,38 = 3.24; P = 0.0797). Similarly mean improvement in VAS leg pain scores at 6 weeks follow-up were 1.4 in the prone group and 1.7 in the lateral group. At 12 weeks follow-up the scores were 1.1 for the prone and 2.4 for the lateral group. Repeated measures analysis showed no significant difference in leg pain scores between the groups (F1,38= 0.76; P = 0.3898). A post-hoc power calculation using the sample VAS SD showed we had reached only 65% power.

Conclusion: This pilot study has shown that sacral epidural injection for sciatica in the lateral position gives superior pain relief compared to the prone position but the difference is not statistically significant. More patients will now be recruited in order to minimise a type II error that may have occurred.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 238 - 238
1 Sep 2005
Barzilay Y Le Huec J Reddy G Friesem T
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Study Design: Prospective Cohort study.

Objective: To prospectively evaluate the Maverick Lumbar Disc Prosthesis (Medtronic, USA) at one year follow-up.

Methods: Prospective analysis of the Maverick Lumbar Disc Prosthesis implanted in the first 30 consecutive patients for the treatment of single-level degenerative disc disease of the lumbar spine resistant to conservative treatment for more than one year.

Subjects: Sixteen females and 14 males with an average age of 44 years and minimum follow-up of 1 year. The prosthesis was implanted at L4-L5 in 18 patients and at L5-S1 in 12.

Outcome Measures: Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) preoperatively and at routine scheduled follow-ups. Radiographic analysis included sagittal balance parameters on standing full length lateral radiographs of the spine and range of motion on flexion/extension dynamic radiographs.

Results: Clinical success (ODI improvement > 15), was 82% and 86%, at 6 months and one year follow-up respectively. The VAS showed an improvement in back pain from 7.1 (+/− 2) pre-operatively to 3.0 (+/− 1.8) post-operatively. At one year there were no device related complications. The measured range of motion in flexion-extension ranged from 3 to 12 degrees (mean range of motion, 6 +/− 4 degrees). There was no significant change in sacral tilt, pelvic tilt, or overall lordosis after disc replacement. In one case the ureter was injured during the approach.

Conclusions: The results of total disc arthroplasty presented here compare favourably with results reported in the literature following ALIF. It appears that the disc prosthesis has enough freedom of motion to allow the patient to maintain normal sagittal and spino-pelvic balance with radiographic evidence of normal range of motion. These early favourable clinical results and the influence on adjacent motion segments can be assessed only after long term follow-up.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 378 - 378
1 Sep 2005
Barzilay Y Bhatia C Reddy G Friesem T Krishna M
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Introduction: Vertebroplasty is an established minimally invasive technique, which provides consistent and sustained pain relief in patients with vertebral fractures. However cement extrusion remains a major problem and has been reported to occur in up to 70% of the cases in some reports. Cement extravasations may occur through the Basivertebral vein, the Segmental vein or through cortical defects. Cement leakage may be Epidural, Anterior, Para-vertebral, Intra-discal or distant. Most often cement leakage is asymptomatic but on occasion it may be a serious complication in the form of Cord compression, pulmonary embolism or Neuralgia.

The incidence of cement leakage can be reduced by the use of high viscosity cement, use of a low pressure injection system, injecting small volumes at each level, introducing the cement under visualization and waiting for cement to set before withdrawing the needle.

Patients and Methods: We describe another technique to help in reduction of cement extrusion.

After satisfactory placement of the Jamshidi needle (used for injecting cement), aspiration is attempted using a 20ml Syringe. A slurry, made of very fine pieces of Gel foam mixed with Omnipaque dye and saline, is injected into the vertebral body. This embolizes the blood channels, which are communicating with the needle. Once no more blood can be aspirated, and no dye is seen extruding into the veins, toothpaste consistency cement is injected under low pressure and fluoroscopic guidance. A post-procedure CT scan was performed in all cases to confirm cement location.

Results: 28 patients underwent PV, 24 of these patients had osteoporotic vertebral fractures and 4 had meta-static lesions. Vertebroplasty was done at 56 symptomatic levels. Using this method, Cement leakage was seen at 12 of the 56 levels operated on (21.4%); at 6 levels leakage was into the adjoining disc, leakage anteriorly was seen at 3 levels, there was 1 leakage into the paravertebral tissues and at 2 levels there was a streak of cement into the vertebral canal in 1 via the venous system and in the other through a cortical defect. None of the leakages were symptomatic. Epidural leakage was seen in 2 patients (3.57%).

Conclusion: A slurry of gelfoam, dye and saline injected prior to cement reduces the incidence of cement extrusion, therefore increasing the safety of this effective procedure.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 377 - 378
1 Sep 2005
Barzilay Y Le-Huec J Reddy G Friesem T
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Introduction: Total disc arthroplasty may offer the same clinical benefits as interbody fusion in symptomatic degenerative disc disease, while providing motion that may protect the adjacent level discs from the abnormal and undue stresses associated with fusion.

Objectives: To prospectively review the preliminary results of the Maverick Lumbar Disc Prosthesis (Medtronic, USA) at maximum 2 year follow-up.

Methods: The first 51 patients (26 M, 25F, age 45.5 mean, 53 levels implanted) were prospectively analyzed. Outcome data included the Oswestry Disability Score (ODI), Visual Analog Scale (VAS) for back and leg pain and SF-36 preoperatively and at routine scheduled follow-ups. Radiographic analysis included sagittal balance parameters and range of motion of the implanted level.

Results: Clinical success (ODI change > 15, FDA) was 82% and 86%, at 6 months and 1 year follow-up respectively. VAS (back) improved from 7.9 (±1.4) to 3.8 (±2.9), and VAS (leg) from (4.6 ± 3.2) to 3.1 (±3.2). All improvements were statistically significant. Two approach, 2 technique and 2 general related complications occurred. Implanted level range of motion ranged from 3 to 12 degrees (mean 6 ± 4 degrees). There was no significant change in any of the sagittal balance variables studied, but a local realignment of the L4-5 L5-S1 segments was found.

Conclusion: These results compare favorably with the short-term clinical outcomes associated with ALIF. It appears that the prosthesis has enough freedom of motion to allow the patient to maintain the natural sagittal and spino-pelvic balance, with normal range of motion. These early favorable clinical results or the influence on adjacent motion segments can be assessed only after a long term prospective randomized study comparing the Maverick to fusion procedures.


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_II | Pages 99 - 99
1 Feb 2003
Lam KS Friesem T Webb JK Mulholland RC
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In a prospective non-randomised study, 28 patients underwent laparoscopic assisted transperitoneal anterior interbody fusion at the lumbosacral junction with the BAK cage over a 3-year period. In laparoscopic group, there were significantly lower blood losses (P< 0. 005), operating times [P< 0. 05], analgesic requirements [P< 0. 05] and postoperative rehabilitation [P< 0. 05). 8 patients developed post-operative nerve root pain, 5 of which settled with nerve root blocks, and there was 1 case of donor site infection. Intraoperative complications included 1 CIA tear, 2 CIV tears and 3 open conversions [11%]. 6 cases [24%] required further surgery at a mean of 14 months [range 4–29 months]. 20 laparoscopic cases completed a subjective self-assessment score with 4 [20%] excellent results, 5 [25%] good, 2 [10%] fair, 8 [40%] same and 1 [5%] worse.

The preoperative Visual Analogue Pain Score [VAPS] and Oswestry Disability Index [ODI] were set at 100 for the purposes of analysing the results [n=number in brackets]:

Results show an improvement in the overall pain and disability. However, at two years patients still continued with some 65% of symptoms.

Laparoscopic assisted anterior spinal fusion with the BAK device is safe and reliable with advantages that include reduced operating time, blood loss, post-operative analgesia requirements and hospitalisation. However, the clinical outcome does not appear to give superior results to other implants and we question whether it use as a stand-alone device is sufficient and would recommend posterior stabilisation to confer improved mechanical stability.