Intramedullary Nail versus Sliding hip screw Inter-Trochanteric Evaluation (INSITE)

Not Applicable

Completed

• Conditions: Trochanteric fracture; Injury, Occupational Diseases, Poisoning; Pertrochanteric fracture

• Registration Number: ISRCTN96308751
• Lead Sponsor: Stryker Trauma GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-18
• Study Completion: 2017-03-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 736

Inclusion Criteria

Current inclusion criteria as of 05/04/2012:
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

Previous inclusion criteria:
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 (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

Current exclusion criteria as of 05/04/2012:
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

Previous 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
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 followup. E.g. 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