MedTrace Logo

Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

NCT01380444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2019-03-07

No results posted yet for this study

Summary

The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery rates, fracture healing rates, fracture related adverse events, and health-related quality of life, including the Parker mobility score and Harris Hip Score.

Conditions

  • Femoral Neck Fractures
  • Intertrochanteric Fracture

Interventions

PROCEDURE

Gamma3 Intramedullary Nails (Stryker)

The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.

PROCEDURE

Sliding Hip Screws

The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.

Sponsors & Collaborators

  • Global Research Solutions

    collaborator INDUSTRY

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Mohit Bhandari, MD, PhD, FRCSC · Global Research Solutions

  • Georgia Mitchell · Stryker Trauma and Extremities

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States
  • Australia
  • Canada
  • China
  • Colombia
  • Denmark
  • Germany
  • Japan
  • Netherlands
  • Norway
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

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 NCT01380444 on ClinicalTrials.gov