Fix or replace enhancing distal humerus fracture outcomes

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18728389

Enrollment

320

Registered

2025-03-19

Start date

2025-05-27

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-articular fracture of the distal humerus AO type B or C Injury, Occupational Diseases, Poisoning

Interventions

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

Eligibility

Sex/Gender

All

Age

60 Years to 100 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Upper limb specific function measured using the Disabilities of the Arm, Shoulder and Hand (DASH) score at 4 months post-surgery	—

Secondary

Measure	Time frame
Current secondary outcomes as of 16/03/2026: 1. Upper limb specific function measured using the DASH at baseline (for pre-injury function), 6 weeks and 12 months post-surgery and at the 49-month whole study timepoint 2. Upper limb specific function measured using the Oxford Elbow Score (OES) at baseline (for pre-surgery function), 6 weeks, 4 and 12 months post-surgery 3. Elbow pain measured using the Patient Rated Elbow Evaluation form (PREE) pain sub-scale at baseline, 6 weeks, 4- and 12 months post-surgery 4. Health-related quality of life (QoL) measured using the EQ-5D-5L at baseline (for pre-injury QoL and pre-surgery QoL), 6 weeks, 4 and 12 months post-surgery 5. Healthcare resource use and comparative cost-effectiveness measured using staff-completed case report forms and a purposely designed patient self-reported questionnaire completed prior to point of discharge from hospital and at 6 weeks, 4 and 12 months post-surgery 6. Patient recovery of function measured using discharge destination, days in usual residence, days to return to driving, days absent from paid work and use of health services prior to point of discharge from hospital and at 6 weeks, 4 and 12 months post-surgery Previous secondary outcomes: 1. Upper limb specific function measured using the DASH at baseline (for pre-injury function), 6 weeks and 12 months post-surgery and at the 49-month whole study timepoint 2. Upper limb specific function measured using the Oxford Elbow Score (OES) at baseline (for pre-surgery function), 6 weeks, 4 and 12 months post-surgery 3. Elbow pain measured using the Patient Rated Elbow Evaluation form (PREE) at baseline, 6 weeks, 4 and 12 months post-surgery 4. Health-related quality of life (QoL) measured using the EQ-5D-5L at baseline (for pre-injury QoL and pre-surgery QoL), 6 weeks, and 4- and 12 months post-surgery 5. Healthcare resource use and comparative cost-effectiveness measured using a purposely designed patient self-reported questionnaire completed pr	—

Measure

Time frame

Current secondary outcomes as of 16/03/2026: 1. Upper limb specific function measured using the DASH at baseline (for pre-injury function), 6 weeks and 12 months post-surgery and at the 49-month whole study timepoint 2. Upper limb specific function measured using the Oxford Elbow Score (OES) at baseline (for pre-surgery function), 6 weeks, 4 and 12 months post-surgery 3. Elbow pain measured using the Patient Rated Elbow Evaluation form (PREE) pain sub-scale at baseline, 6 weeks, 4- and 12 months post-surgery 4. Health-related quality of life (QoL) measured using the EQ-5D-5L at baseline (for pre-injury QoL and pre-surgery QoL), 6 weeks, 4 and 12 months post-surgery 5. Healthcare resource use and comparative cost-effectiveness measured using staff-completed case report forms and a purposely designed patient self-reported questionnaire completed prior to point of discharge from hospital and at 6 weeks, 4 and 12 months post-surgery 6. Patient recovery of function measured using discharge destination, days in usual residence, days to return to driving, days absent from paid work and use of health services prior to point of discharge from hospital and at 6 weeks, 4 and 12 months post-surgery Previous secondary outcomes: 1. Upper limb specific function measured using the DASH at baseline (for pre-injury function), 6 weeks and 12 months post-surgery and at the 49-month whole study timepoint 2. Upper limb specific function measured using the Oxford Elbow Score (OES) at baseline (for pre-surgery function), 6 weeks, 4 and 12 months post-surgery 3. Elbow pain measured using the Patient Rated Elbow Evaluation form (PREE) at baseline, 6 weeks, 4 and 12 months post-surgery 4. Health-related quality of life (QoL) measured using the EQ-5D-5L at baseline (for pre-injury QoL and pre-surgery QoL), 6 weeks, and 4- and 12 months post-surgery 5. Healthcare resource use and comparative cost-effectiveness measured using a purposely designed patient self-reported questionnaire completed pr

—

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactPriya Sharma

priya.sharma2@nottingham.ac.uk

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026