Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery rates, fracture healing rates, fracture related adverse events, and health-related quality of life, including the Parker mobility score and Harris Hip Score.

Detailed Description
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Hip fractures are becoming a more prevalent issue worldwide, leading to profound morbidity, and in some cases, mortality. Currently the most common method of surgical treatment includes the use of a sliding hip screw over a Gamma intramedullary nail, but there is conflicting evidence regarding which device has a lower revision surgery rate and complication rate. Recent improvements in implant design of the Gamma3 nail, demonstrating decreased rates of femoral shaft fractures and improved function, provide compelling rationale for the conduct of a large, definitive trial. This trial is a definitive, multi-center, concealed randomized controlled trial. Surgeons will use one of the two surgical strategies in patients who have sustained a trochanteric fracture; the Gamma3 intramedullary nail or the sliding hip screw. Clinical assessments will occur at the time of hospital admission, post-surgery, 13 weeks, 26 weeks, 52 weeks, and 104 weeks.

Official Title
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A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip

Conditions
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Femoral Neck Fractures, Intertrochanteric Fracture

Intervention / Treatment
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* Procedure: Gamma3 Intramedullary Nails (Stryker)
* Procedure: Sliding Hip Screws


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men or women aged 18 years and older (with no upper age limit). An intertrochanteric fracture (stable or unstable), AO Type 31-A1 or 31-A2, confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI). Low energy fracture (defined as a fall from standing height). No other major trauma. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker. Anticipated medical optimization of the patient for operative fixation of the proximal femur. Operative treatment within 7 days after the trauma.(Operative treatment should take place as soon as possible as permitted by each institution's standard of care.) Provision of informed consent by patient or proxy. Exclusion Criteria: Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip). Retained hardware around the affected proximal femur. Infection around the proximal femur (i.e., soft tissue or bone). Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia). Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. Patients with a subtrochanteric fracture. Patients with a pathologic fracture. Patients with a reverse oblique fracture pattern, fracture AO Type 31-A3. Obesity in the judgment of the attending surgeon. Off-label use of the implant. Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year). Likely problems, in the judgment of the Site Investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support. Patient is enrolled in another ongoing drug or surgical intervention trial. If the attending surgeon believes that there is another reason to exclude this patient from INSITE. This reason will be documented on the case report forms (CRFs).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gamma3 Intramedullary Nails | Procedure: Gamma3 Intramedullary Nails (Stryker)<br>* The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.<br>* Other names: Intramedullary Nail (IM Nail);|
| Active Comparator: 2<br>Sliding Hip Screws | Procedure: Sliding Hip Screws<br>* The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.<br>* Other names: Compression Screw and Side Plate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQol-5D at 52 weeks in individuals with trochanteric fractures. | Up to 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured with the Parker mobility score and the Harris Hip Score. | Up to 104 weeks | 
| Fracture healing rates | A fracture is to be considered healed when there is obliteration of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior and lateral (or oblique) radiographs. | Up to 104 weeks | 
| Fracture-related adverse events | Including mortality, femoral shaft fracture, avascular necrosis (although rare in trochanteric fractures), nonunion, malunion (shortening, varus deformity, valgus deformity and rotational malunion), implant breakage or failure, and infection (i.e., superficial and deep). | Up to 104 weeks | 
| Revision surgery rates | Any unplanned surgery after the initial fixation to promote fracture healing (non-union), relieve pain (avascular necrosis, early or late implant failure), treat infection, or improve function will be considered a study event. | Up to 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intertrochanteric fracture, Gamma3 intramedullary nail, Sliding hip screw