NCT02627040

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Florida Orthopaedic Institute · Network
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Intertrochanteric Fracture
• Hip Fracture

Interventions

Type	Name	Description
DEVICE	InterTan Intertrochanteric Nail	Cephalomedullary fixation of intertrochanteric fracture with an InterTan Intertrochanteric Nail
DEVICE	Gamma 3 Intertrochanteric Nail	Cephalomedullary fixation of intertrochanteric fracture with an Gamma 3 Intertrochanteric Nail

Timeline

• Start date: 2015-11-30
• Primary completion: 2020-08-31
• Completion: 2020-09-01
• First posted: 2015-12-10
• Last updated: 2019-11-18

Locations

2 sites across 1 country: United States