Expired Study
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Lexington, Kentucky 40504


Purpose:

The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.


Study summary:

Study Design: Phase 1 Sites will collect the following types of data: Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events Follow-up Visit schedule - 6 week ± 2 weeks - 6 month ± 1 month - 1 year ± 3 months - 2 years ± 3 months - 3 years ± 3 months - 4 years ± 3 months - 5 years ± 3 months Phase 2: Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.


Criteria:

Inclusion Criteria: - Skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis Exclusion Criteria: - Patients with: Osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease


NCT ID:

NCT00578851


Primary Contact:

Study Director
Kara Mezger
Zimmer Biomet


Backup Contact:

N/A


Location Contact:

Lexington, Kentucky 40504
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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