Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE4
31 participants
INTERVENTIONAL
2009-04-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trilogy AB Acetabular Hip Implant System
Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System
Total hip replacement with ceramic on ceramic treatment surfaces.
Interventions
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Trilogy AB Acetabular Hip Implant System
Total hip replacement with ceramic on ceramic treatment surfaces.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Schrock, MD
Role: PRINCIPAL_INVESTIGATOR
Schrock Orthopedic Research
Gwo-Chin Lee, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania/Penn Presbyterian Hospital
Locations
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Shrock Orthopedic Research
Fort Lauderdale, Florida, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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06-300, Revised 3-1-2010
Identifier Type: OTHER
Identifier Source: secondary_id
06-300
Identifier Type: -
Identifier Source: org_study_id