Clinical Trial: Intertrochanteric Femoral Fracture Fixation Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Randomized Trial of Intertrochanteric Femoral Fractures Treated With a Single Screw Versus a Two-integrated Screw Cephalo-medullary Nail.

Brief Summary: The main goal of the study is to determine which cephalomedullary nail results in a better functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan cephalomedullary nail. Outcomes will be reviewed over a 12 month follow-up period.

Detailed Summary:

Primary Hypotheses:

Patients who maintain their initial fracture reduction and subsequent position over time with minimal femoral neck shortening and varus will demonstrate significantly improved functional abilities, including gait and abductor function.

Secondary Objective:

  • Whether radiographic differences in femoral neck shortening and varus collapse translate into a worse functional outcome to the patient.
  • Whether there are differences in mortality between treatments
  • Whether there is a time frame follow up after which there is no difference in outcomes.
  • Evaluate the device used for fracture stabilization as a potentially contributing factor for maintenance of normal or near-normal abductor function and gait.

Primary Outcome:

The primary outcome will be functional abilities at 3, 6 and 12 months after injury. The following measures of functional ability will be utilized:

Methods:

This is a prospective, randomized non-blinded study. Patients will be identified as they present to the orthopaedic trauma service of Tampa General Hospital with a qualifying injury to determine their interest in participating in the study. Written informed consent will be obtained prior to initiation of any study procedures.

Group A will undergo cephalomedullary nail-based single screw intertrochanteric hip fracture fixation device (Gamma 3 nail). Group B will receive the integrated dual screw intertrochante
Sponsor: Florida Orthopaedic Institute

Current Primary Outcome: Hip Function [ Time Frame: 6 months post-operatively ]

Hip Function measured with Harris Hip Score.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Functional outcome [ Time Frame: 6 months post-operatively ]
    Functional outcome will be measured using the following outcome measurement: Gait analysis using MiniSun's IDEEA® LifeGait System, a portable device for assessment of functional gait outcomes.
  • Walking ability [ Time Frame: 3 months post-operatively ]
    Subjects will wear a pedometer applied in the immediate post-operative period, and will continue to wear it for 3 months. Total walking steps will be measured.
  • Hip range of motion [ Time Frame: 6 months post-operatively ]
    Range of motion of hip measured with Harris Hip Score.
  • Pain [ Time Frame: 6 months post-operatively ]
    Pain measured with Harris Hip Score.


Original Secondary Outcome: Same as current

Information By: Florida Orthopaedic Institute

Dates:
Date Received: November 25, 2015
Date Started: November 2015
Date Completion: October 2019
Last Updated: February 13, 2017
Last Verified: February 2017