Trigen Intertan vs SHS RCT Version 1
Research type
Research Study
Full title
Functional Advantages of TRIGEN™ INTERTAN™ over Sliding Hip Screw in Subjects with Trochanteric Hip Fracture: A Randomised Controlled Trial
IRAS ID
192415
Contact name
Gayle Fyvie
Contact email
Sponsor organisation
Smith & Nephew Orthopaedics AG
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
This study is a randomised controlled trial comparing the Trigen Intertan Intramedullary Nail to Sliding Hip Screws in the treatment of intertrochanteric hip fractures (AO/OTA 31-A1 and A2). The study will involve several questionnaires (Functional Independence Measure, EuroQol-5D, Harris Hip Score and AM-PAC) to record data on functional recovery and quality of life as well as other outcome measures such as opioid usage, return to pre-injury residential and ambulatory status, radiological outcomes and a get-up and go test. Participating subjects will be randomised to one of the treatments and all will be followed up for one year post-surgery. The subjects will receive a daily assessment until discharge from hospital, telephone follow-ups at 8 weeks, 12 weeks and 12 months, and one outpatient follow-up visit at 6 months. The study hypothesis is that patients treated with Trigen Intertan will have a better score for the motor portion of the Functional Independence Measure at 8 weeks post-surgery.
REC name
West of Scotland REC 4
REC reference
16/WS/0006
Date of REC Opinion
9 Mar 2016
REC opinion
Further Information Favourable Opinion