A Multi-Center Randomized Controlled Trial of Intramedullary Nails versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip
- Conditions
- hip fractureleg fractureproximal femur fracture10017322
- Registration Number
- NL-OMON44033
- Lead Sponsor
- Stryker
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
1. Adult men or women aged 18 years and older (with no upper age limit).
2. A trochanteric fracture (stable or unstable) 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*.
8. Provision of informed consent by patient or proxy.
*Operative treatment should take place as soon as possible as permitted by each
institution*s standard of care.
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 rond de aangedane proximale 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.
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Health Related Quality of Life<br /><br>To assess the impact of Gamma3 intramedullary nails versus sliding hip screws<br /><br>on health-related quality of life as measured by the EuroQol-5D at 52 weeks<br /><br><br /><br><br /><br><br /><br><br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>Health Related Quality of Life<br /><br>health-related quality of life as measured with the Parker mobility score and<br /><br>the Harris Hip Score.<br /><br><br /><br>Fracture healing rates<br /><br>A fracture is to be considered healed when there is obliteration of the<br /><br>fracture lines by newly formed bone along the cortices and within the<br /><br>trabecular bone on anteroposterior and lateral (or oblique) radiographs.<br /><br><br /><br>Fracture-related adverse events<br /><br>Including mortality, femoral shaft fracture, avascular necrosis (although rare<br /><br>in trochanteric fractures), nonunion, malunion (shortening, varus deformity,<br /><br>valgus deformity and rotational malunion), implant breakage or failure, and<br /><br>infection (i.e., superficial and deep).<br /><br><br /><br>Revision surgery rates</p><br>