Clinical trial NCT02627040: Intertrochanteric Femoral Fracture Fixation Trial
Official title: A Prospective Randomized Trial of Intertrochanteric Femoral Fractures Treated With a Single Screw Versus a Two-integrated Screw Cephalo-medullary Nail.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intertrochanteric Fracture
Hip Fracture
Lead sponsor: Florida Orthopaedic Institute
Sponsor class: NETWORK
First posted: 2015-12-10
Enrollment: 95
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hip Function
timeFrame: 6 months post-operatively
Secondary outcomes:
measure: Functional outcome
timeFrame: 6 months post-operatively
measure: Walking ability
timeFrame: 3 months post-operatively
measure: Hip range of motion
timeFrame: 6 months post-operatively
measure: Hip Pain
timeFrame: 6 months post-operatively
Other outcomes:
Locations:
city: Brandon
country: United States
facility: Brandon Regional Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Hassan R Mir, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: