Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
95 participants
INTERVENTIONAL
2015-11-30
2020-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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InterTan Intertrochanteric Nail
'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail with an InterTan device (two-integrated screws)
InterTan Intertrochanteric Nail
Cephalomedullary fixation of intertrochanteric fracture with an InterTan Intertrochanteric Nail
Gamma 3 Intertrochanteric Nail
'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail and Gamma 3 locking nail (single screw)
Gamma 3 Intertrochanteric Nail
Cephalomedullary fixation of intertrochanteric fracture with an Gamma 3 Intertrochanteric Nail
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Skeletally mature patients over the age of 60; both genders.
* Community ambulators.
Exclusion Criteria
* 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.
60 Years
ALL
No
Sponsors
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Florida Orthopaedic Institute
NETWORK
Responsible Party
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Principal Investigators
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Hassan R Mir, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Florida Orthopaedic Institute
Locations
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Brandon Regional Hospital
Brandon, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Countries
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Other Identifiers
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00023144
Identifier Type: -
Identifier Source: org_study_id
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