Trial of acute femoral fracture fixatio
- Conditions
- Fragility fractures of the distal femurMusculoskeletal Diseases
- Registration Number
- ISRCTN92089567
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29137679 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31549959 results (added 27/09/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31061043/ results (added 04/06/2020) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31371167/ feasibility results (added 14/06/2023) 2019 Results article in https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3597-8 mixed methods process evaluation (added 14/06/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 23
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Recruitment rate, calculated throughout the study and determined as the number of eligible participants who gave consent to participate<br>2. Completion rate of the EQ-5D-5L is measured 4 months post injury
- Secondary Outcome Measures
Name Time Method 1. Demential Quality of Life questionnaire (DEMQoL) at baseline, 6-weeks post injury, and 4-months post-injury<br>2. Disability rating index (DRI) at baseline, 6-weeks post injury, and 4-months post-injury<br>3. Mixed methods analysis of a process evaluation, including patient and staff interviews throughout the length of the trial