Objectives

A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults.

The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs.

Cite this article: Bone Joint Res 2014;3:169–74.

The peer review process for the evaluation of manuscripts for publication needs to be better understood by the orthopaedic community. Improving the degree of transparency surrounding the review process and educating orthopaedic surgeons on how to improve their manuscripts for submission will help improve both the review procedure and resultant feedback, with an increase in the quality of the subsequent publications. This article seeks to clarify the peer review process and suggest simple ways in which the quality of submissions can be improved to maximise publication success.

Cite this article: Bone Joint Res 2013;2:245–7.

Background

Accurate and reproducible radiological assessment of shoulder replacement prostheses over time is important for identifying failure or to provide reassurance. A number of clearly defined radiological parameters have been described to help standardise the radiological assessment of prostheses. To our knowledge, this is the first study conducted to test the reproducibility and reliability of these measurements.

Background

A recent Cochrane review has shown that total shoulder arthroplasty (TSA) seems to offer an advantage in terms of shoulder function over hemiarthroplasty, with no other obvious clinical benefits. This is the first study to compare complication rates on a national scale.

Background

In 2011 20% of intracapsular fractured neck of femurs were treated with an uncemented hemiarthroplasty in the English NHS. National guidelines recommend cemented implants, based on evidence of less pain, better mobility and lower costs. We aimed to compare complications following cemented and uncemented hemiarthroplasty using the national hospital episode statistics (HES) database in England.

Prevalence of rotator cuff tears increases with advancing age (Ellman et al). In spite of proximal humeral fractures being common in the elderly, the influence of a coexistent rotator cuff tear on outcome has, to our knowledge, not been previously investigated. This study prospectively assessed whether the presence of a rotator cuff tear in association with a proximal humeral fracture influences functional prognosis.

85 patients treated conservatively for proximal humeral fractures were evaluated prospectively with Ultrasonography to determine the status of the rotator cuff. Every patient was managed by immobilisation of the arm in a sling for two weeks followed by a course of physiotherapy based on the Neer regime. Functional outcome was measured using the Constant shoulder score and the Oxford shoulder score, at 3-months and 12-months post injury.

Sixty-six of the 85 patients were female. The fractures were equally distributed for hand dominance. There were 27 patients with an undisplaced fracture, 34 patients with Neer's Type II fracture and 24 patients with Neer's Type III and IV fracture. There were 43 patients with full thickness cuff tears and 42 patients with no cuff tear or a partial thickness tear. Full thickness cuff tears were much more frequent in the over 60 year age group, which is consistent with the known increased incidence of cuff tears with increasing age.

The outcome scores at 3 and 12 months showed no statistically significant difference for either the Constant score or the Oxford score with regards to cuff integrity. Analysis of these scores showed no correlation between presence or absence of a full thickness cuff tear and shoulder function

The results of this study indicate that rotator cuff integrity is not a predictor of shoulder function at 12 months following proximal humeral fracture, as measured by outcome scores. This suggests that there is therefore no clinical indication for routine imaging of the rotator cuff in patients for whom conservative management is the preferred treatment option.

Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified.

Compression and absolute stability are important in the management of intra-articular fractures. We compared tension band wiring with plate fixation for the treatment of fractures of the olecranon by measuring compression within the fracture. Identical transverse fractures were created in models of the ulna. Tension band wires were applied to ten fractures and ten were fixed with Acumed plates. Compression was measured using a Tekscan force transducer within the fracture gap. Dynamic testing was carried out by reproducing cyclical contraction of the triceps of 20 N and of the brachialis of 10 N. Both methods were tested on each sample. Paired t-tests compared overall compression and compression at the articular side of the fracture.

The mean compression for plating was 819 N (sd 602, 95% confidence interval (CI)) and for tension band wiring was 77 N (sd 19, 95% CI) (p = 0.039). The mean compression on the articular side of the fracture for plating was 343 N (sd 276, 95% CI) and for tension band wiring was 1 N (sd 2, 95% CI) (p = 0.038).

During simulated movements, the mean compression was reduced in both groups, with tension band wiring at −14 N (sd 7) and for plating −173 N (sd 32). No increase in compression on the articular side was detected in the tension band wiring group.

Pre-contoured plates provide significantly greater compression than tension bands in the treatment of transverse fractures of the olecranon, both over the whole fracture and specifically at the articular side of the fracture. In tension band wiring the overall compression was reduced and articular compression remained negligible during simulated contraction of the triceps, challenging the tension band principle.

Large and massive rotator cuff tears can cause persistent pain and significant disability. These tears are often chronic with substantial degeneration of the involved tendons. Surgical treatment is challenging and the functional outcome after repair less predictable then for smaller tears. The aim of this study was to determine the functional outcome and rate of re-rupture after mini-open repair of symptomatic large and massive rotator cuff tears using a modified two-row technique.

Twenty-four patients, who were operated on under the care of a single surgeon between 2003 and 2006, were included in this study. Patients were assessed prospectively before and at a mean of 27 months after surgery using Constant Score and Oxford Shoulder Score. This assessment was carried out by an independent physiotherapist specialising in shoulder rehabilitation. At follow-up an ultrasound was carried out by a musculoskeletal radiographer to determine the integrity of the rotator cuff repair. Patient satisfaction was assessed using a simple questionnaire.

The mean Constant Score improved significantly from 36 preoperatively to 68 postoperatively (p< 0.0001), the mean Oxford Shoulder Score from 39 to 20 (p< 0.0001). Four patients (16.7%) had a re-rupture diagnosed by ultrasound. 87.5% of patients were satisfied with the outcome of their surgery. Tear size and repair integrity did not significantly influence functional outcome. 87.5% of patients were satisfied or very satisfied with the outcome of their surgery.

This study shows that the two-row repair of large and massive rotator cuff tears using a mini-open approach is an effective method of repair with a comparatively low re-rupture rate. It significantly improves the functional outcome and leads to a very high patient satisfaction. We conclude that these results justify repair of large to massive rotator cuff tears when possible, irrespective of chronicity of symptoms.

The 2010 Fellows undertook a six-week journey through centres of orthopaedic excellence along the East Coast of Canada and the United States. What we learned and gained from the experience and each other is immeasurable, but five areas particularly stand out; education, research, service delivery, financial insights and professional development.

There are many types of treatment used to manage the frozen shoulder, but there is no consensus on how best to manage patients with this painful and debilitating condition. We conducted a review of the evidence of the effectiveness of interventions used to manage primary frozen shoulder using the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Physiotherapy Evidence Database, MEDLINE and EMBASE without language or date restrictions up to April 2009. Two authors independently applied selection criteria and assessed the quality of systematic reviews using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Data were synthesised narratively, with emphasis placed on assessing the quality of evidence.

In total, 758 titles and abstracts were identified and screened, which resulted in the inclusion of 11 systematic reviews. Although these met most of the AMSTAR quality criteria, there was insufficient evidence to draw firm conclusions about the effectiveness of treatments commonly used to manage a frozen shoulder. This was mostly due to poor methodological quality and small sample size in primary studies included in the reviews. We found no reviews evaluating surgical interventions.

More rigorous randomised trials are needed to evaluate the treatments used for frozen shoulder.

Low-energy fractures of the proximal humerus indicate osteoporosis and it is important to direct treatment to this group of patients who are at high risk of further fracture. Data were prospectively collected from 79 patients (11 men, 68 women) with a mean age of 69 years (55 to 86) with fractures of the proximal humerus in order to determine if current guidelines on the measurement of the bone mineral density at the hip and lumbar spine were adequate to stratify the risk and to guide the treatment of osteoporosis. Bone mineral density measurements were made by dual-energy x-ray absorptiometry at the proximal femur, lumbar spine (L2-4) and contralateral distal radius, and the T-scores were generated for comparison. Data were also collected on the use of steroids, smoking, the use of alcohol, hand dominance and comorbidity.

The mean T-score for the distal radius was −2.97 (sd 1.56) compared with −1.61 (sd 1.62) for the lumbar spine and −1.78 (sd 1.33) for the femur. There was a significant difference between the mean lumbar and radial T scores (1.36 (1.03 to 1.68); p < 0.001) and between the mean femoral and radial T-scores (1.18 (0.92 to 1.44); p < 0.001). The inclusion of all three sites in the determination of the T-score increased the sensitivity to 66% compared with that of 46% when only the proximal femur and lumbar spine were used. This difference between measurements in the upper limb compared with the axial skeleton and lower limb suggests that basing risk assessment and treatment on only the bone mineral density taken at the hip or lumbar spine may misrepresent the extent of osteoporosis in the upper limb and the subsequent risk of fracture at this site.

The assessment of osteoporosis must include measurement of the bone mineral density at the distal radius to avoid underestimation of osteoporosis in the upper limb.

Introduction: The surgical management of proximal humeral fractures continues to be an unsolved problem for the orthopaedic surgeon. Disagreement remains over how best to fix the more challenging complex fractures in younger patients where the ultimate goals of treatment are restoration of a painless shoulder, adequate function, and preservation of humeral head viability.

The PHILOS plate attempts to improve on previously designed implants by preserving the biological integrity of the humeral head articular fragment. The minimally invasive technique minimises soft tissue damage whilst at the same time securing the reduction using multiple locking screws with angular stability, thus allowing early mobilisation.

Methods: Retrospective review of the notes and x-ray images of 54 fractures treated with the PHILOS plate between Jan 2000 and Aug 2005. Data including baseline demographics, the presence of any complications and the need for reoperation were collected. In addition 43 (81%) patients were contacted and Oxford (OSS) and Disabilities of the Arm, Shoulder and Hand (DASH) scores were calculated to assess functional recovery. All patients were contacted at a minimum of 6 months following fixation with an average follow up of 18 months (Range 6–41 months)

We also present a cost analysis relating to the use of the PHILOS plate in practice.

Results: 54 fractures in 53 patients (25F:28M). Average age 54.4. There were 26 2-part, 15 3-part and 13 4-part fractures. A total of 11 (20%) patients had complications of which 7 (13%) required reoperation. These complications included deep infection (3 cases), AVN (4), Non Union (3) and plate impingement (1).

Mean OSS and DASH at follow up were 24.8 (S.D 11.6) and 28.0 (S.D 26.9) respectively. Worse scores were seen in those patients who had complications (OSS 39.4 Vs 22.6, DASH 58.2 Vs 23.4) although this difference was not statistically significant. There was also a trend for poorer scores with increasing fracture complexity and better scores in those patients operated upon by surgeons with a specific interest in the upper limb and in patients whose surgeon had performed more than 5 fixations.

Conclusion: Our series reports a much higher complication rate (20%) than that previously published. Whilst those patients who do not suffer complications reported good functional outcomes the presence of postoperative complications was associated with poorer results. Outcomes following surgery were affected by patient, implant and surgeon related factors. Given the high rate of serious complications and their detrimental affect on outcome surgeons should give serious consideration to the appropriateness of using such implants. To clarify these issues, further prospective randomised trials are needed.

The aim of this study was to determine the functional outcome and rate of re-tears following mini-open repair of symptomatic large and massive tears of the rotator cuff using a two-row technique.

The 24 patients included in the study were assessed prospectively before and at a mean of 27 months (18 to 53) after surgery using the Constant and the Oxford Shoulder scores. Ultrasound examination was carried out at follow-up to determine the integrity of the repair. Patient satisfaction was assessed using a simple questionnaire.

The mean Constant score improved significantly from 36 before to 68 after operation (p < 0.0001) and the mean Oxford Shoulder score from 39 to 20 (p < 0.0001). Four of the 24 patients (17%) had a re-tear diagnosed by ultrasound. A total of 21 patients (87.5%) were satisfied with the outcome of their surgery. The repair remained intact in 20 patients (83%). However, the small number of re-tears (four patients) in the study did not allow sufficient analysis to show a difference in outcome in relation to the integrity of the repair.

Introduction: Scoring systems for assessment of shoulder function are invaluable tools in determining changes in a patient’s condition. We utilised two commonly used assessment tools in patients with conservatively treated proximal humeral fractures to establish their behaviour in this patient group.

Methods: OSS and Constant Scores were collected prospectively at 3 and 12 months post injury, for 103 consecutive patients treated conservatively for proximal humeral fractures. Comparison of the scores was undertaken by creating scattergraphs, calculating Pearson’s correlation coefficient and producing Bland and Altman plots. Sensitivity to change was calculated using paired t-tests. Linear regression analysis was finally performed to predict Constant Score from the OSS.

Results: 177 sets of scores were collected. The scores correlated well with a correlation coefficient (r) of 0.84 (p< 0.001,n=177). This relationship was equally strong at 3 (r=0.77 (p< 0.001,n=94)) and 12 months (r=0.87 (p< 0.001,n=83)) and demonstrated a clear relationship between the scoring systems. Bland and Altman plots showed good agreement between the scores. Both scores were sensitive to change over time (OSS (t(81)=6.14,p< 0.001), Constant (t(80)=−10.27,p< 0.001)). Regression analysis produced a regression equation (R2=0.70) of: Constant Score=99.3-(1.67 times OSS). This level of model fit was statistically significant (F(1,175)=412.8,(p< 0.001))

Conclusion: This study provides information about the behaviour of two frequently used functional scoring systems in patients with proximal humeral fractures. Based on our finding we feel that these scores are appropriate assessment tools in these patients. The OSS may also be considered as an alternative for assessing longer term follow up as, being solely subjective, it is easier to administer and correlates well with the Constant Score.

Upper gastrointestinal (GI) bleeding in patients who undergo hip and knee arthroplasty tends to be associated with NSAID use, steroid intake, pre-existing peptic ulcers and smoking. The use of Aspirin for thromboprophylaxis is an added risk for the occurrence of GI Bleed. The aim of this study was to determine if the use of peri-operative oral Ranitidine reduces the incidence of GI bleeding when Aspirin thromboprophylaxis is used for hip and knee arthroplasty.

Data from 1491 consecutive patients who underwent Hip and knee replacements at the James cook university hospital (Group 1) and 886 patients who underwent Hip and Knee replacements at the Friarage hospital, Northallerton (Group 2) was analysed to determine the incidence of Gastro intestinal Bleeding. All patients received 150 mg of Aspirin per day for a period of six weeks from the day of surgery. Additionally patients operated at the Friarage Hospital received 300 mg of oral Ranitidine per day, for three postoperative days. Patients with clinically symptomatic GI bleeding were evaluated by the Upper GI team.

We observed that patients in Group 1 had a higher incidence of overt upper GI haemorrhage (n=14), which was statistically significant (p < 0.014) compared with patients in group 2(n=1). From the pooled data of both groups, there were 18 reported patients with symptomatic pulmonary embolism (0.75%) 3 of which were fatal (0.12%), phlebitis of deep leg veins in 31 patients (1.3%), deep vein thrombosis in 34 patients (1.43%), 5 of whom had embolic episodes, post operative infection in 22 patients (1.13%), and postoperative haemorrhage in 5 patients (0.2%). Thromboembolic phenomenon and pulmonary embolism was confirmed by autopsy in the three cases.

Based on this experience, we recommend the use of peri-operative gastric protection when aspirin is used for thromboprophylaxis in hip and knee arthroplasty.

Introduction: Many authors have stated that open reduction and internal fixation of displaced ankle fractures give better results than conservative management (Hughes et al, Clin Orthop 1979; Tunturi et al, Acta Orthop Scand 1983; Philips et al, JBJS 1985 and ). However, there is little information on the long-term outcome of operated ankle fractures. There is inadequate knowledge of patient perception of ankle function following operative treatment of these injuries.

Aim: To analyse long-term results following operative treatment of these fractures using a patient centred outcome measure.

Methods: 112 patients had undergone operative fixation of isolated, closed bi-malleolar ankle fractures between 1992 and 1996 at Middlesbrough General Hospital. All patients had undergone operative fixation using standard AO principles. An independent assessor ascertained the quality of reduction using standardised radiological parameters (Joy et al JBJS 1974, Sarkisian & Cody J Trauma 1976, Mont et al J Ortop Trauma 1992) to assess the post-operative X-ray films. All postoperative reductions were within the parameters of a good reduction.

The modified Olerud & Molander ankle score questionnaire was sent by post to all patients identified living in the region.

Results: 66 out of 112 patients responded; 34 (52%) leading a sedentary lifestyle and 32 (48%) a moderate/ active lifestyle. Mean age of the patients was 47 years. The follow-up period ranged from 5 to 11 years (average 7 years).

Olerud and Molander scores ranged from 5 to 100, with a mean score of 66.5 (SD 27.6), and median score of 70. Only 9 (13.6%) patients had a score of 100. Comparisons between Olerud and Molander scores were made with regard to: gender, whether metal work was removed at a second operation, Weber classification (B vs C) and patient’s lifestyle. No significant differences were observed

The associations between Olerud and Molander score and the key variables were assessed using non-parametric (Spearman’s) correlation coefficients. None of the variables considered were significantly associated with Olerud and Molander score.

Conclusion: The study would suggest that, despite modern fixation techniques, few patients following bi-malleolar ankle fracture have a symptom free ankle. There is no obvious parameter to predict outcome in patients who are managed appropriately for these injuries.

Background: Prevalence of rotator cuff tears increases with advancing age (Ellman et al). In spite of proximal humeral fractures being common in the elderly, the influence of a coexistent rotator cuff tear on outcome has, to our knowledge, not been previously investigated.

Aim: This study assess whether the presence of a rotator cuff tear in association with a proximal humeral fracture influences prognosis.

Methods: 85 patients treated conservatively for proximal humeral fractures were evaluated prospectively with Ultrasonography to determine the status of the rotator cuff. Every patient was managed by immobilisation of the arm in a sling for three weeks followed by a course of physiotherapy based on the Neer regime. Functional outcome was measured using the Constant shoulder score and the Oxford shoulder score, at 3-months and 12-months post injury.

Results: Sixty-Six of the 85 patients were female. The fractures were equally distributed for hand dominance. There were 27 patients with an undisplaced fracture, 34 patients with Neer’s Type II fracture and 24 patients with Neer’s Type III and IV fracture. There were 43 patients with full thickness cuff tears and 42 patients with no cuff tear or a partial thickness tear. Full thickness cuff tears were much more frequent in the over 60 year age group, which is consistent with the known increased incidence of cuff tears with increasing age.

The outcome scores at 3 and 12 months showed no statistically significant difference for either the Constant score or the Oxford score with regards to cuff integrity. Analysis of these scores showed no correlation between presence or absence of a full thickness cuff tear and shoulder function

Conclusion: The results of this study indicate that rotator cuff integrity is not a predictor of shoulder function at 12 months following proximal humeral fracture, as measured by outcome scores. This suggests that there is therefore no clinical indication for routine imaging of the rotator cuff in patients for whom conservative management is the preferred treatment option.

Background: The incidence of proximal humeral fractures is increasing with time. There is continuing debate about the indications for surgical intervention for this relatively common injury. Baseline data on functional outcome is essential in order to study the effect of surgical intervention. Functional outcome scores provide reliable and valid judgments of health status and the benefits of treatment. During our preparation of a study proposal on this topic to the Health Technology Assessment Program recently, we noted the lack of such data on outcome scores in the current literature.

Aim: To assess the functional outcome using the Constant and Oxford scores in patients treated conservatively for proximal humeral fractures.

Methods: We prospectively studied 103 consecutive patients who were treated conservatively for proximal humeral fractures. Patient demographics, fracture type (Neer), hand dominance and comorbidity were recorded. Constant and Oxford shoulder scores were recorded 3 and 12 months post injury.

Results: The average Constant shoulder score for males was significantly higher (better outcome) and the Oxford shoulder score significantly lower (better outcome) as compared to females. The scores were not affected by hand dominance. Although the raw scores tended to be worse with 3 or 4 part fractures the difference in the mean scores between the various Neer fracture types did not reach convential levels of significance.

A trend towards lesser degrees of improvement in the outcome scores was noted with increasing age. The degree of improvement in the outcome scores was not affected by sex, limb dominance or fracture type (Neer’s classification).

Conclusion: This study indicates the average behaviour of the Constant and Oxford scores with conservative treatment of proximal humeral fractures. This data should help with sample size and power calculations when studying interventions for this injury. We hope that this data will provide a baseline to help inform future study designs on proximal humeral fractures.