Lorna Goodchild

Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus: The PROFHER Randomized Clinical Trial

IMPORTANCE The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing. OBJECTIVE To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck. DESIGN, SETTING, AND PARTICIPANTS A pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis. INTERVENTIONS Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups. MAIN OUTCOMES AND MEASURES Primary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality. RESULTS There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, -1.33 to 2.84 points]; P = .48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, -0.84 to 4.39 points]; P = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; P = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; P = .28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively; P = .58); and mortality (9 patients vs 5 patients; P = .27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay. CONCLUSIONS AND RELEVANCE Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus. TRIAL REGISTRATION isrctn.com Identifier: ISRCTN50850043.

Large and massive tears of the rotator cuff FUNCTIONAL OUTCOME AND INTEGRITY OF THE REPAIR AFTER A MINI-OPEN PROCEDURE

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.

Evidence-based clinical guidelines for the diagnosis, assessment and physiotherapy management of contracted (frozen) shoulder: quick reference summary

Evidence-based clinical guidelines for the diagnosis, assessment and physiotherapy management of contracted (frozen) shoulder: quick reference summary Nigel C.A. Hanchard a,∗, Lorna Goodchild b, Jackie Thompson c, Tracey O’Brien d, Dot Davison e, Chris Richardson e a Health and Social Care Institute, School of Health and Social Care, Teesside University, Middlesbrough, TS1 3BA, UK b Department of Rehabilitation, James Cook University Hospital, Middlesbrough, UK c Department of Physiotherapy, County Durham and Darlington Foundation Trust, Darlington, UK d Department of Physiotherapy, Langbaurgh Primary Care Trust, Guisborough, UK e Department of Physiotherapy, Middlesbrough Primary Care Trust, Middlesbrough, UK

The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults.

BACKGROUND Proximal humeral fractures account for 5-6% of all fractures in adults. There is considerable variation in whether or not surgery is used in the management of displaced fractures involving the surgical neck. OBJECTIVE To evaluate the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment of the majority of displaced fractures of the proximal humerus involving the surgical neck in adults. DESIGN A pragmatic parallel-group multicentre randomised controlled trial with an economic evaluation. Follow-up was for 2 years. SETTING Recruitment was undertaken in the orthopaedic departments of 33 acute NHS hospitals in the UK. Patient care pathways included outpatient and community-based rehabilitation. PARTICIPANTS Adults (aged ≥ 16 years) presenting within 3 weeks of their injury with a displaced fracture of the proximal humerus involving the surgical neck. INTERVENTIONS The choice of surgical intervention was left to the treating surgeons, who used techniques with which they were experienced. Non-surgical treatment was initial sling immobilisation followed by active rehabilitation. Provision of rehabilitation was comparable in both groups. MAIN OUTCOME MEASURES The primary outcome was the Oxford Shoulder Score (OSS) assessed at 6, 12 and 24 months. Secondary outcomes were the 12-item Short Form health survey, surgical and other shoulder fracture-related complications, secondary surgery to the shoulder or increased/new shoulder-related therapy, medical complications during inpatient stay and mortality. European Quality of Life-5 Dimensions data and treatment costs were also collected. RESULTS The mean age of the 250 trial participants was 66 years and 192 (77%) were female. Independent assessment using the Neer classification identified 18 one-part fractures, 128 two-part fractures and 104 three- or four-part fractures. OSS data were available for 215 participants at 2 years. We found no statistically or clinically significant differences in OSS scores between the two treatment groups (scale 0-48, with a higher score indicating a better outcome) over the 2-year period [difference of 0.75 points in favour of the surgery group, 95% confidence interval (CI) -1.33 to 2.84; p = 0.479; data from 114 surgery and 117 non-surgery participants] or at individual time points. We found no statistically significant differences between surgical and non-surgical group participants in SF-12 physical or mental component summary scores; surgical or shoulder fracture-related complications (30 vs. 23 respectively); those undergoing further shoulder-related therapy, either surgery (11 vs. 11 respectively) or other therapy (seven vs. four respectively); or mortality (nine vs. five respectively). The base-case economic analysis showed that, at 2 years, the cost of surgical intervention was, on average, £1780.73 more per patient (95% CI £1152.71 to £2408.75) than the cost of non-surgical intervention. It was also slightly less beneficial in terms of utilities, although this difference was not statistically significant. The net monetary benefit associated with surgery is negative. There was only a 5% probability of surgery achieving the criterion of costing < £20,000 to gain a quality-adjusted life-year, which was confirmed by extensive sensitivity analyses. CONCLUSIONS Current surgical practice does not result in a better outcome for most patients with displaced fractures of the proximal humerus involving the surgical neck and is not cost-effective in the UK setting. Two areas for future work are the setting up of a national database of these fractures, including the collection of patient-reported outcomes, and research on the best ways of informing patients with these and other upper limb fractures about initial self-care. TRIAL REGISTRATION Current Controlled Trials ISRCTN50850043. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 24. See the NIHR Journals Library website for further project information.

Exploring the outcomes in studies of primary frozen shoulder: is there a need for a core outcome set?

PurposeIn our study we explored the need to define a core outcome set for primary frozen shoulder.MethodsWe investigated the outcomes used by studies included in a systematic review of the management of primary frozen shoulder; surveyed which primary outcome measures health care professionals considered important; and re-examined papers previously obtained for a systematic review of patients’ views of interventions for frozen shoulder to investigate their views on outcomes.ResultsThirty-one studies investigated the outcomes range of movement (28 studies), pain (22), function and disability (22), adverse events (13), quality of life (7) and other outcomes (5). Many different types of pain and ranges of movement were measured. Function and disability was measured using fifteen instruments, the content of which varied considerably. Function and disability, pain and range of movement (132, 108 and 104 respondents, respectively) were most often cited by health care professionals as the primary outcome measure that should be used. Searches identified one paper that included patients’ views. Outcomes of importance to patients were pain at night, general pain, reduced mobility (resulting in modification of activities) and the emotional impact of frozen shoulder.ConclusionsWe identified a diverse range of outcomes that have been used or are considered to be important. The development of a core outcome set would improve the design and reporting of studies and availability of data for evidence synthesis. Methods used to develop a core outcome set should be robust, transparent and reflect the views of all stakeholders.

Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial

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. Methods These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. Results All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. Conclusion In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335–40.

Do partial thickness, bursal side cuff tears affect outcome following arthroscopic subacromial decompression? A prospective comparative cohort study

Background: The present study aimed to compare medium-term clinical outcomes of patients following arthroscopic subacromial decompression (ASAD): those with intact rotator cuff with two groups of increasing size of partial thickness bursal-side tears. Methods: Patients undergoing shoulder arthroscopy by a single surgeon had pre- and postoperative Constant scores prospectively recorded. Arthroscopic surgery included the assessment of any supraspinatus tears using the Ellman criteria, as well as ASAD and cuff debridement. Groups were created based on the status of rotator cuff and size of bursal tear. Outcome in these patient groups was then compared and analyzed Results: Seventy-four patients were suitable for inclusion in the study: 32 patients without a cuff tear; 21 patients with a cuff tear of 9 mm or less in length; and 21 patients with a cuff tear of 10 mm or more in length. Baseline characteristics of the three groups were similar. All three groups showed a significant improvement in their Constant scores following surgery. There was, however, no significant difference in Constant scores between the three groups. Conclusions: The results of the present study show that patients with varying sizes of bursal-side tears respond to ASAD as well as those with no rotator cuff tear.