Completed Bones, Joints & Muscles Cancer

Pragmatic multi-centre randomised trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults

In plain English

AI plain-English summary

Every year, around 250 patients with broken shoulders will be randomly assigned to receive either surgery or a sling and physiotherapy, to settle a long-running medical dispute. Proximal humerus fractures account for 4-5% of all fractures, and roughly 40% involve the surgical neck—a break that often heals poorly. Surgeons disagree sharply on whether operating improves outcomes, and the evidence is too weak to guide them. This trial directly addresses that uncertainty. If the results show that surgery offers no meaningful advantage, thousands of older patients each year could avoid an unnecessary operation, its recovery time, and its risks. If surgery proves superior, the NHS can standardise care around the most effective approach, reducing the current variation in practice. Either way, the trial will also produce cost-effectiveness data, helping the health service allocate resources more rationally. The trial is pragmatic by design: surgeons use techniques they already know, avoiding learning-curve complications, and both groups receive comparable rehabilitation. This makes the findings directly applicable to everyday NHS practice.

View original technical description
Proximal humeral fractures, which occur mainly in older adults, account for approximately 4-5% of all fractures. Approximately 40% of these fractures are displaced fractures involving the surgical neck. Management of this group of fractures is often challenging and the outcome is frequently unsatisfactory. In particular it is not clear whether surgery gives better outcomes than non-surgical treatment. Currently there is much variation in the use of surgery as well as a lack of good quality evidence to inform this decision. We aim to undertake a pragmatic UK-based multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of surgical versus standard non-surgical treatment for adults with an acute closed displaced fracture of the proximal humerus with involvement of the surgical neck. Only those people for whom a participating surgeon would consider surgical treatment will be included. The choice of surgical methods is left to the surgeon, the only requirement being that they must use techniques that they are fully experienced with. This will avoid 'learning curve' problems. We will promote good standards of non-surgical care, similarly insisting on care-provider competence, and emphasize the need for comparable provision of rehabilitation for both groups of patients. We aim to recruit 250 patients from approximately 18 NHS trauma centres throughout the UK. These patients will be followed-up for 2 years. The primary outcome, collected via questionnaires completed by the trial participants at 6, 12 and 24 months, is the Oxford Shoulder Score. This is a 12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment. We will also collect data for other outcomes including general health measures and complications, and for an economic evaluation. The trial is run by the Universities of Teesside and York.

Related Research

Grants with similar aims, by meaning.

Effectiveness and cost-effectiveness of Reverse Shoulder Arthroplasty versus Hemiarthroplasty versus Non-surgical care for acute 3 and 4 part fractures of the proximal humerus in older adults - The PROFHER-2 Randomised Clinical Trial
Randomised Evaluation of rehabilitation after ACute proximal Humerus fracture (the REACH trial)
The HUmeral SHaft fracture trial: A multi-centre prospective randomised superiority trial of surgical versus nonsurgical interventions for humeral shaft fractures in patients aged 18 years or older
The HUmeral SHaft fracture trial (HUSH)
The HUmeral SHaft fracture trial: A multi-centre prospective randomised superiority trial of surgical versus nonsurgicalinterventions for humeral shaft fractures in patients aged 18 years or older

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