Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

Completed · Not applicable

Conditions studied: Femoral Neck Fractures, Intertrochanteric Fracture

In brief

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.

Key facts

Study ID

NCT01380444

Run by

Stryker Trauma and Extremities

People needed

880

Starts

2011-12-01

Expected to finish

2017-03-01

Last updated by the study team

2019-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Community Regional Medical Center — Fresno, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Scott&White Memorial Hospital — Temple, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• The Royal Melbourne Hospital — Parkville, Victoria, Australia
• Health Sciences Centre Winnipeg — Winnipeg, Manitoba, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Chaoyang Hospital — Beijing, Beijing Municipality, China
• Sixth People's Hospital — Shanghai, Shanghai Municipality, China
• 2nd Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China
• Clinica El Rosario Sede El Tesoro — Medellín, Antioquia, Colombia
• Hospital Universitario Santa Clara — Bogotá, Cundinamarca, Colombia
• Aarhus University Hospital — Aarhus, Denmark
• Universitätsklinikum Schleswig-Holstein, Campus Lübeck — Lübeck, Germany
• Robert-Bosch-Krankenhaus — Stuttgart, Germany
• Tsukuba Medical Center — Tsukuba, Ibaraki, Japan
• Onze Lieve Vrouwe Gasthuis — Amsterdam, Netherlands
• Helse Sunnmore Alesund Sjukehus — Ålesund, Norway
• Charlotte Maxeke Johannesburg Academic Hospital — Parktown, South Africa
• Frenchay Hospital — Bristol, United Kingdom
• The Royal Liverpool University Hospital — Liverpool, United Kingdom
• The Royal Berkshire Hospital — Reading, United Kingdom

Full record on ClinicalTrials.gov

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