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

Surgical versus non-surgical treatment for acute anterior shoulder dislocation.

BACKGROUND: Acute anterior dislocation is the commonest type of shoulder dislocation. Subsequently, the shoulder is less stable and more susceptible to redislocation, especially in active young adults. OBJECTIVES: To compare surgical versus non‐surgical treatment for acute anterior dislocation of the shoulder. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (14 August 2009), The Cochrane Library (2009, Issue 3), MEDLINE (1950 to August 2009), EMBASE (1980 to August 2009), trial registration databases, conference proceedings and reference lists of articles. SELECTION CRITERIA: Randomised or quasi‐randomised controlled trials comparing surgical with conservative interventions. DATA COLLECTION AND ANALYSIS: Both authors independently selected trials, assessed methodological quality and extracted data. Where appropriate, results were pooled. MAIN RESULTS: The four included studies involved 163 participants, mainly active young adult males. All had had a primary (first time) traumatic anterior shoulder dislocation. Methodological quality was variable. All participants of one trial returned to active military duty. Two trials respectively reported similar numbers with reduced sports participation or non return to previous activities. The other, an inadequately reported, trial found significantly fewer people in the surgical group failed to attain previous levels of sports activity. Pooled results from all four trials showed that subsequent instability, either redislocation or subluxation, was statistically significantly less frequent in the surgical group (risk ratio 0.25, 95% confidence interval 0.14 to 0.44). This result remained statistically significant (risk ratio 0.32, 95% confidence interval 0.17 to 0.59) for the three trials reported in full. Half (17/33) of the conservatively treated patients with shoulder instability in these three trials opted for subsequent surgery. Different, mainly patient rated, functional assessment measures for the shoulder were recorded in these trials. The results were more favourable, usually statistically significantly so, in those treated surgically. The only complication reported was a septic joint in a surgically treated patient. There was no information on shoulder pain, long‐term complications or resource use. AUTHORS' CONCLUSIONS: Limited evidence supports primary surgery for young adults, usually male, engaged in highly demanding physical activities who have sustained their first acute traumatic shoulder dislocation. There is no evidence available to determine which treatment is better for other patient groups. Sufficiently powered, good quality, well reported randomised trials are required that compare surgical treatment with conservative treatment for these injuries, including in people at lower risk of recurrence. Long‐term surveillance of outcome, looking at shoulder disorders including osteoarthritis is also required

Five-year follow-up results of the PROFHER trial comparing operative and non-operative treatment of adults with a displaced fracture of the proximal humerus

AIMS: The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up. PATIENTS AND METHODS: Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied. RESULTS: OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non-operative treatment at each follow-up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ-5D-3L data showed no significant between-group differences in quality of life over time. CONCLUSION: These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years. Cite this article: Bone Joint J 2017;99-B:383-92