PROFHER2 Trial - Version 1.0
Research type
Research Study
Full title
A three-arm randomised controlled trial to assess the effectiveness and cost-effectiveness of reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical care for acute three and four- part fractures of the proximal humerus in patients over 65 years of age – Proximal Fracture Of the Humerus: Evaluation by Randomisation trial No.2 (PROFHER-2).
IRAS ID
238346
Contact name
Amar Rangan
Contact email
Sponsor organisation
South Tees Hospitals NHS Foundation Trust
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Breaking (fracturing) the upper part of the arm at the shoulder (proximal humerus) most commonly occurs in people over 65 years old from a simple fall. When the bone is broken into more than 2 parts (typically 3 or 4 parts), patients may undergo surgery to replace the broken bone with an artificial shoulder joint.
There are two main types of joint replacement used: hemiarthroplasty (replacing the broken ball of the joint) and reverse shoulder arthroplasty (replaces the ball with a socket and the socket with a ball (hence ‘reverse’)). Another common treatment is non-surgical care where the arm is supported in a sling to allow the broken bone to heal naturally. Following each of these treatments, physiotherapy is needed to regain arm function.
We do not know which surgery leads to the best recovery and whether surgery is better than non-surgical care. PROFHER-2 will assess whether reverse shoulder arthroplasty is more effective than hemiarthroplasty at restoring use of the shoulder and arm, whether shoulder replacement surgery is more effective than non-surgical treatment for these fractures, and which treatment is best value for money.
Patients aged 65 years or older, with complex fractures of the proximal humerus, will be invited to take part. Patients who agree to take part will receive one of the three treatments selected at random using a computer system. If patients need general anaesthetic to treat a dislocation they will receive one of the two types of surgery. All patients will receive physiotherapy and rehabilitation, and will have usual check-ups with their treating doctor. Questionnaires will assess how well patients can use their arm and shoulder over a two-year period and we also plan to follow-up patients after five years to assess whether they need any further surgery.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0125
Date of REC Opinion
2 May 2018
REC opinion
Favourable Opinion