Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures
Stopped early · Not applicable
Conditions studied: Hip Fractures
In brief
The purpose of this study is to look at the effect of locking or not locking a set screw when placing a rod and screws device in the thigh bone and hip to fix hip fractures. The set screw is an extra screw in the device that will not allow the screw that goes into the ball of the ball and socket joint in the hip to slide at all in relation to the rod in the thigh bone, which it goes through. It is not known whether it is better to lock the set screw (not allow sliding of the hip screw) or leave it unlocked (allow sliding of the hip screw). Participants in this study are patients with intertrochanteric hip fractures receiving standard care for this injury (lining the fracture up in a normal position and inserting a rod in the thigh bone with a screw that goes through the rod into the ball of the ball and socket of the hip). Patients who consent to participate will be randomized to one of two arms : 1. Set screw is unlocked or 2. Set screw is locked. Participants will all get standard postoperative care and standard postoperative xrays.
Key facts
- Study ID
- NCT02345369
- Run by
- Bassett Healthcare
- People needed
- 3
- Starts
- 2015-01-01
- Expected to finish
- 2016-05-24
- Last updated by the study team
- 2018-08-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All subjects 18 years or older who are:
- mentally competent to give consent and complete the follow up questionnaires
- being treated for an intertrochanteric hip fracture,
- classified as Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) 31-A2 or A3
- plan to be treated with an intramedullary hip screw
You may not qualify if…
- infection in the involved joint or surrounding soft tissues,
- pathological fractures as a result of metastatic or primary bone tumors, progressive or debilitating neurological conditions resulting in significant movement or gait disorders, congenital bone disorders or heritable bone disorders (excluding osteoporosis and osteopenia),
- severe dementia,
- nonambulatory patients.
Where it is running
- Bassett Healthcare Network — Cooperstown, New York, United States
Full record on ClinicalTrials.gov
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