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Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures

NCT02345369 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-08-02

Study results available
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Summary

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.

Conditions

  • Hip Fractures

Interventions

DEVICE

Locked Set Screw

Fixation of hip fracture with intramedullary hip screw with locking of the set screw

DEVICE

Unlocked Set Screw

Fixation of hip fracture with intramedullary hip screw without locking of the set screw

Sponsors & Collaborators

  • Bassett Healthcare

    lead OTHER

Principal Investigators

  • jocelyn wittstein, MD · Bassett Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-05-24
Completion
2016-05-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02345369 on ClinicalTrials.gov