Intertrochanteric Femoral Fracture Fixation Trial
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Orthopedic, Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 9/9/2018 |
| Start Date: | November 30, 2015 |
| End Date: | October 2020 |
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.
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.
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.
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.
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.
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sites
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1 Tampa General Cir
Tampa, Florida 33606
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Hassan Mir, MD
Phone: 813-253-2068
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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