Intertrochanteric Femoral Fracture Fixation Trial

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

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.

Study Overview

• Status: Unknown
• Conditions: Hip Fracture; Intertrochanteric Fracture
• Intervention / Treatment: Device: InterTan Intertrochanteric Nail; Device: Gamma 3 Intertrochanteric Nail

Detailed Description

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 intertrochanteric hip fracture fixation device (Intertan nail). Patient outcomes will be analyzed using intention to treat principles. Following randomization assignment, surgeons will all follow the identical described surgical technique, with the only variable being the implant used. Post-operative immobilization and time to weight bearing and rehabilitation protocols will be again identical for all patients regardless of fixation technique.

• Study Type: Interventional
• Enrollment (Anticipated): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Brandon, Florida, United States, 33511
      • Brandon Regional Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients surgically treated for an intertrochanteric femur fracture at Tampa General Hospital.

  • Skeletally mature patients over the age of 60; both genders.
  • Community ambulators.

Exclusion Criteria:

• Patients with ipsilateral lower extremity injury
• Patients under age 60
• Co-existent, severe knee or back problems
• Muscle contracture around the knee or hip joint
• Individuals who have had TKA within 6 months
• Body mass index (BMI; kg/m2) >40
• Suspicious of pathologic fracture (tumor in origin)
• Pre-op mobility: Non ambulatory; ambulatory indoors with living support
• Cognitive impairment or dementia
• Prisoners or impending incarceration
• Homeless or no stable address.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: InterTan Intertrochanteric Nail; 'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail with an InterTan device (two-integrated screws)	Device: InterTan Intertrochanteric Nail; Cephalomedullary fixation of intertrochanteric fracture with an InterTan Intertrochanteric Nail
Active Comparator: Gamma 3 Intertrochanteric Nail; 'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail and Gamma 3 locking nail (single screw)	Device: Gamma 3 Intertrochanteric Nail; Cephalomedullary fixation of intertrochanteric fracture with an Gamma 3 Intertrochanteric Nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip Function	Hip Function measured with Harris Hip Score.	6 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	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.	6 months post-operatively
Walking ability	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.	3 months post-operatively
Hip range of motion	Range of motion of hip measured with Harris Hip Score.	6 months post-operatively
Hip Pain	Pain measured with Harris Hip Score.	6 months post-operatively

Collaborators and Investigators

• Sponsor: Florida Orthopaedic Institute
• Investigators: Principal Investigator: Hassan R Mir, MD, MBA, Florida Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2015
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 00023144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share data.