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Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN)

NCT00555945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2011-06-27

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 rate of revision surgery in individuals with inter-trochanteric fractures. Secondary outcomes include fracture healing rates, fracture related complications, and health-related quality of life.

Conditions

  • Femoral Neck Fractures
  • Intertrochanteric Fracture

Interventions

PROCEDURE

Gamma3 intramedullary nail (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 Screw

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

  • Stryker Osteosynthesis

    collaborator UNKNOWN

  • Global Research Solutions

    collaborator INDUSTRY

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Mohit Bhandari, MD FRCSC MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Canada
  • Denmark
  • Sweden

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 NCT00555945 on ClinicalTrials.gov