None listed
Conditions
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.
Interventions
The interventional treatment used in the study is an intramedullary nail. The implant is a short, interlocking intramedullary device that consists of a sliding lag screw, which passes through a short intramedullary nail. The duration of the implant procedure is approximately 1 hour. The implant is intended to remain in place permanently.
Sponsors
Stryker Australia Ptd Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Adult men or women aged 18 years and older (with no upper age limit). 2.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). 3.Low energy fracture (defined as a fall from standing height). 4.No other major trauma. 5.Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker. 6.Anticipated medical optimization of the patient for operative fixation of the proximal femur. 7.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.) 8.Provision of informed consent by patient or proxy.
Exclusion criteria
1.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). 2.Retained hardware around the affected proximal femur. 3.Infection around the proximal femur (i.e., soft tissue or bone). 4.Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia). 5.Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. 6.Patients with a subtrochanteric fracture. 7.Patients with a pathologic fracture. 8.Patients with a reverse oblique fracture pattern, fracture AO Type 31-A3. 9.Obesity in the judgment of the attending surgeon. 10.Off-label use of the implant. 11.Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year). 12.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. 13.Patient is enrolled in another ongoing drug or surgical intervention trial. 14.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).
Outcome results
None listed