Intertrochanteric Femoral Fracture Fixation Trial

Florida Orthopaedic Institute

Status: Unknown

Conditions: Hip Fracture; Intertrochanteric Fracture

Treatments: Device: Gamma 3 Intertrochanteric Nail; Device: InterTan Intertrochanteric Nail

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02627040

00023144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

InterTan Intertrochanteric Nail

Active Comparator group

Description:

'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail with an InterTan device (two-integrated screws)

Treatment:

Device: InterTan Intertrochanteric Nail

Gamma 3 Intertrochanteric Nail

Active Comparator group

Description:

'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail and Gamma 3 locking nail (single screw)

Treatment:

Device: Gamma 3 Intertrochanteric Nail