A Clinical Investigation of the C2a-Taper™ Acetabular System
This trial is active, not recruiting.
|Conditions||osteoarthritis, avascular necrosis, congenital hip dysplasia, traumatic arthritis|
|Treatment||c2a - taper™ acetabular system|
|Sponsor||Biomet Orthopedics, LLC|
|Start date||April 2006|
|End date||October 2017|
|Trial size||28 participants|
|Trial identifier||NCT00578851, ORTHO.CR.H021, P050009|
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.
Harris Hip Score, Radiographic Evaluation
time frame: 5 years
time frame: 10 years
Male or female participants at least 18 years old.
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
|Official title||Post Approval Study of the C2a-Taper™ Acetabular System|
|Description||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.|
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