A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Femoral Neck Fractures
- Sponsor
- Stryker Trauma and Extremities
- Enrollment
- 880
- Locations
- 26
- Primary Endpoint
- Health Related Quality of Life
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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-A
- •Obesity in the judgment of the attending surgeon.
- •Off-label use of the implant.
Outcomes
Primary Outcomes
Health Related Quality of Life
Time Frame: Up to 104 weeks
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.
Secondary Outcomes
- Fracture healing rates(Up to 104 weeks)
- Health Related Quality of Life(Up to 104 weeks)
- Revision surgery rates(Up to 104 weeks)
- Fracture-related adverse events(Up to 104 weeks)