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
Intra-articular fracture of the distal humerus AO type B or C
Participants will be recruited from secondary care accident and emergency (A&E) or orthopaedic clinics after a multidisciplinary team (MDT) discussion, which occurs daily in all UK centres, to assess general suitability. Eligible participants will receive a Participant Information Sheet (PIS) about the trial, typically around their first A&E presentation or via remote contact, following an elbow fracture diagnosis and eligibility confirmation. Interested participants will discuss the trial with a direct care team member and sign a consent form if willing to participate. The research team will collaborate closely with the direct care team at each centre to optimize local screening and recruitment. Prior to randomization, participants will complete questionnaires to evaluate their current status and pre-injury elbow condition. Afterwards, they will be individually randomised to receive one of the two treatments: elbow arthroplasty (EA) or Open Reduction Internal Fixation (ORIF) in a 1:1 ratio. Dynamic randomisation will use a probabilistic minimisation algorithm to balance across arms by recruitment site, sex, diabetes, injury to the dominant limb, and fragility fracture. Elbow arthroplasty refers to any surgical intervention involving joint replacement, where metal components are inserted into the bone to replace all or part of the elbow joint, as deemed suitable by the treating specialist. Elbow repair, also known as open reduction internal fixation (ORIF), involves surgical fixation of the fracture using plates and screws, as determined appropriate by the treating specialist. The surgery will be performed by a trained and experienced surgeon, which may require traveling to a specialist hospital. This is common for these injuries as the surgery is performed by highly specialised surgeons. Surgery should be completed within 14 days of injury. During surgery, participants will receive their allocated procedure. However, the surgeon may decide to perform a differen
Current key inclusion criteria as of 16/03/2026: 1. Aged ≥ 60 years 2. Intra-articular distal humerus fracture (AO type B or C) 3. Suitable for surgical treatment with either EA or ORIF 4. Injury to anticipated day of surgery ≤28 days Current key inclusion criteria as of 16/08/2025: 1. Aged ≥ 60 years 2. Intra-articular distal humerus fracture (AO type B or C) 3. Suitable for surgical treatment with either EA or ORIF 4. Injury to the anticipated day of surgery ≤21 days Previous key inclusion criteria: 1. Aged ≥60 years 2. Intra-articular distal humerus fracture 3. Suitable for surgical treatment with either elbow arthroplasty (EA) or ORIF 4. Injury to the anticipated day of surgery ≤21 days
Current key exclusion criteria as of 14/08/2025: 1. Open fracture 2. Metastatic pathological fracture 3. Patient not suitable for surgery 4. Patient unable to adhere to trial protocol/procedures 5. Multiple fractures in the same arm precluding one treatment option 6. Any other injury that, in the opinion of the treating clinician, is likely to significantly alter arm function/ outcomes 7. Previous participation in the FOREST clinical trial Previous key exclusion criteria: 1. Open fracture 2. Pathological fracture 3. Patient not suitable for surgery 4. Patient unable to adhere to trial protocol/procedures 5. Multiple fractures in the same arm precluding one treatment option 6. Any other injury that, in the opinion of the treating clinician, is likely to significantly alter arm function/ outcomes