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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InterTan Intertrochanteric Nail | Active Comparator | 'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail with an InterTan device (two-integrated screws) |
|
| Gamma 3 Intertrochanteric Nail | Active Comparator | 'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail and Gamma 3 locking nail (single screw) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterTan Intertrochanteric Nail | Device | Cephalomedullary fixation of intertrochanteric fracture with an InterTan Intertrochanteric Nail |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hip Function | Hip Function measured with Harris Hip Score. | 6 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome | Functional outcome will be measured using the following outcome measurement: Gait analysis using MiniSun's IDEEA® LifeGait System, a portable device for assessment of functional gait outcomes. | 6 months post-operatively |
| Walking ability |
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Inclusion Criteria:
Patients surgically treated for an intertrochanteric femur fracture at Tampa General Hospital.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan R Mir, MD, MBA | Florida Orthopaedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brandon Regional Hospital | Brandon | Florida | 33511 | United States | ||
| Tampa General Hospital |
There is no plan to share data.
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| Gamma 3 Intertrochanteric Nail | Device | Cephalomedullary fixation of intertrochanteric fracture with an Gamma 3 Intertrochanteric Nail |
|
Subjects will wear a pedometer applied in the immediate post-operative period, and will continue to wear it for 3 months. Total walking steps will be measured. |
| 3 months post-operatively |
| Hip range of motion | Range of motion of hip measured with Harris Hip Score. | 6 months post-operatively |
| Hip Pain | Pain measured with Harris Hip Score. | 6 months post-operatively |
| Tampa |
| Florida |
| 33606 |
| United States |
| D007869 |
| Leg Injuries |