Trilogy AB Acetabular Hip System Post Approval Study
Stopped early · Phase 4
Conditions studied: Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia, Traumatic Arthritis
In brief
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, which will facilitate assessment of the clinical performance of the Zimmer Trilogy AB Acetabular Hip System.
Key facts
- Study ID
- NCT00715026
- Run by
- Zimmer Biomet
- People needed
- 31
- Starts
- 2009-04-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2014-11-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Shrock Orthopedic Research — Fort Lauderdale, Florida, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.