Status:
TERMINATED
Trilogy AB Acetabular Hip System Post Approval Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This is a post-approval study with prospective enrollment in the United States and a retrospective enrollment outside the United States to obtain functional, quality of life and radiographic data, whi...
Detailed Description
To obtain functional, quality of life and radiographic data to evaluate the clinical performance of the Zimmer Trilogy AB Acetabular Hip System in primary total hip replacement surgery.
Eligibility Criteria
Inclusion
- Non-obese patients
- The patient is a good candidate for a primary hip arthroplasty using the Zimmer Trilogy AB Acetabular Hip System.
- Patient is willing and able to give informed consent to participate in the follow-up program.
- Patient is suitable for surgery and able to participate in the follow-up program.
Exclusion
- Skeletally immature
- Rheumatoid arthritis
- Osteoradionecrosis
- Infection
- Nerve or muscle disease that may have a negative affect on gait or weight bearing
- Loss of abductor musculature in the affected limb
- Poor bone stock
- Poor skin coverage around the hip joint
- Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray
- Previous total or cemented hemi-arthroplasty of the affected hip
- Previous pinning or plating of the affected hip
- Patients with heavy labor jobs or extreme activity levels
- Patients who participate in sports activities or require deep flexion
- Patients who are obese
- Patients who have other disabilities
- Patients who are unwilling or unable to give consent, or to comply with the protocol and follow-up program.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00715026
Start Date
April 1 2009
End Date
June 1 2012
Last Update
November 26 2014
Active Locations (2)
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1
Shrock Orthopedic Research
Fort Lauderdale, Florida, United States, 33136
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104