Status:
TERMINATED
THP Hip Fracture Plating System Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Femur Fracture
Femur Fracture Intertrochanteric
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.
Detailed Description
Primary Endpoint: • Revision rate due to device related complication(s) or non-union of the femur. Secondary Endpoints: • Radiographic and clinical fracture healing of the proximal femur using stan...
Eligibility Criteria
Inclusion
- Patient must be 18 years of age or older.
- Patient must be eligible for an open reduction and internal fixation of the proximal femur.
- Patient must have an intracapsular or intertrochanteric fracture.
- Patient must have need for alignment, stabilization, and reduction of bone fractures.
- Patient must have ability and willingness to follow postoperative care instructions until healing is complete.
- Patient must be in good nutritional state.
- Patient must be able and willing to sign the IRB/EC approved informed consent.
Exclusion
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Patient is known to be pregnant or breastfeeding.
- Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent.
- Infection.
- Patient conditions including bloody supply limitations, obesity or insufficient quantity or quality of bone.
- Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- Patient has foreign body sensitivity. Where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device.
- Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03870477
Start Date
January 16 2019
End Date
March 10 2021
Last Update
May 12 2022
Active Locations (3)
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1
Eskenazi Health
Indianapolis, Indiana, United States, 46202
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042