Intertrochanteric Femoral Fracture Fixation Trial

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02627040
• Other study ID #: 00023144
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2015
• Est. completion date: September 2020

Study information

• Verified date: November 2019
• Source: Florida Orthopaedic Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: September 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Intertrochanteric Fracture

Intervention

Device:
• InterTan Intertrochanteric Nail
Cephalomedullary fixation of intertrochanteric fracture with an InterTan Intertrochanteric Nail
• Gamma 3 Intertrochanteric Nail
Cephalomedullary fixation of intertrochanteric fracture with an Gamma 3 Intertrochanteric Nail

Locations

Country	Name	City	State
United States	Brandon Regional Hospital	Brandon	Florida
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Orthopaedic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip Function	Hip Function measured with Harris Hip Score.	6 months post-operatively
Secondary	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
Secondary	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
Secondary	Hip range of motion	Range of motion of hip measured with Harris Hip Score.	6 months post-operatively
Secondary	Hip Pain	Pain measured with Harris Hip Score.	6 months post-operatively