Status:
TERMINATED
N-Force Screws Augmented With N-Force Blue in Hip Fractures
Lead Sponsor:
Zimmer Biomet
Conditions:
Intracapsular Proximal Femur Fracture
Garden Grade I Subcapital Fracture of Femoral Neck
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.
Detailed Description
Primary Endpoint: • Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Secondary Endpoints: * Radiographic and clin...
Eligibility Criteria
Inclusion
- Patient has primary Garden I or II intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with N-Force Blue.
- Patient receives operative treatment within 7 days of injury.
- Patient was ambulatory before injury.
- Patient is 50 years of age or older.
Exclusion
- Patient has Garden III or IV intracapsular proximal femur fracture.
- Patient has major cognitive impairment (including dementia).
- Patient is on dialysis.
- Patient is not expected to survive follow-up schedule.
- Patient is expected to have problems maintaining follow-up compliance, i.e. patients with no fixed address, patients not mentally competent to give informed consent, etc. (Investigator's discretion).
- Patient is a prisoner.
- Patient is known to be pregnant and/or breastfeeding.
- Patient is a known alcohol or drug abuser.
- Patient had previous/has active acute or chronic infections, especially at the site of operation.
- Patient has non-viable bone, or has areas where surrounding bone is not viable or capable of supporting and anchoring the implant.
- Patient has traumatic injuries with open wounds or close to the proximal femur fracture, which are likely to become infected.
- Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
- Physical conditions, in the opinion of the investigator, that would prohibit adequate implant support or impede healing.
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03807349
Start Date
February 21 2019
End Date
March 11 2021
Last Update
June 8 2022
Active Locations (4)
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1
Stanford University
Stanford, California, United States, 94305
2
Washington University
St Louis, Missouri, United States, 63130
3
Donald B Slocum Research and Education Foundation
Eugene, Oregon, United States, 97401
4
University of Utah
Salt Lake City, Utah, United States, 84108