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Trial of acute femoral fracture fixation

For patients with an acute fragility fracture of the distal femur, is there a clinical and cost-effectiveness difference between locking plate fixation and retrograde intramedullary nail fixation?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN92089567
Enrollment
52
Registered
2016-05-26
Start date
2016-10-14
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Fragility fractures of the distal femur Musculoskeletal Diseases Fragility fractures of the distal femur

Interventions

Randomisation will be via a web based secure randomisation service, and will take into account the hospital and cognitive status of the patient. This will make sure that around the same number of pati

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients of 18 years old and above 2. Present to participating hospitals with a fracture of the distal femur (i.e. involving the distal 2 "Muller" squares) 3. Attending surgeon feels that the patient will benefit from internal fixation of the fracture

Exclusion criteria

Exclusion criteria: 1. Patients who have a knee or hip arthroplasty that requires revision 2. A pre-existing arthroplasty that precludes fixation with an intramedullary nail 3. Patients with pre-existing femoral deformity will also be excluded

Design outcomes

Primary

MeasureTime frame
1. Recruitment rate, calculated throughout the study and determined as the number of eligible participants who gave consent to participate 2. Completion rate of the EQ-5D-5L is measured 4 months post injury

Secondary

MeasureTime frame
1. Demential Quality of Life questionnaire (DEMQoL) at baseline, 6-weeks post injury, and 4-months post-injury 2. Disability rating index (DRI) at baseline, 6-weeks post injury, and 4-months post-injury 3. Mixed methods analysis of a process evaluation, including patient and staff interviews throughout the length of the trial

Countries

England, United Kingdom

Contacts

Public ContactRobin Lerner
traffix@ndorms.ox.ac.uk+44 1865 227912

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026