Fix Or Replace Enhancing distal humeruS fracTure outcomes (FOREST)
Research type
Research Study
Full title
A phase III, multicentre, parallel-group, superiority RCT to compare upper limb specific function between elbow arthroplasty and fixation of the fracture using plates and screws in patients presenting with a fracture of the distal humerus.
IRAS ID
324227
Contact name
B J Ollivere
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Clinicaltrials.gov Identifier
2204, Nottingham Clinical Trials Unit Reference Number
Duration of Study in the UK
3 years, 8 months, 29 days
Research summary
Every year, over 4,500 adults in the UK suffer a fractured elbow. These injuries are especially common among older people. The most serious fractures involve joint damage, leading to stiffness and pain that can make everyday activities difficult.
For older people with this type of fracture, there are two main treatments:
Elbow Arthroplasty (total or hemi): Involves replacing one or both sides of the elbow with an artificial metal and plastic joint.
Internal Fixation: Involves realigning and then repairing the break using metal plates and screws.
Both treatments are widely used across the UK and are not experimental. However, we do not yet know which treatment is the most effective. The FOREST trial aims to compare these two treatments to determine which is better. We will recruit 320 participants over 37 months from at least 20 different hospitals in the UK, with 160 participants in each treatment group.
Participants will be randomly assigned to receive one of the two treatments. Participants will be asked to complete several questionnaires over a one-year period—at baseline, 6 weeks, 4 months, and 12 months after surgery. Additionally, there will be a longer-term follow-up about 49 months into the study.
Questionnaires can be completed at routine clinic appointments, or they can be sent via text, email, or post, according to the participants preference.
In summary the trial will help doctors and researchers understand which treatment offers the best outcomes for patients with fractured elbows, ultimately improving care for others in the future.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
25/SC/0015
Date of REC Opinion
6 Mar 2025
REC opinion
Further Information Favourable Opinion