Avascular Necrosis, Congenital Hip Dysplasia, Osteoarthritis, Traumatic Arthritis
Conditions
Keywords
Hip Arthroplasty, Hip Arthritis
Brief summary
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.
Detailed 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.
Interventions
DEVICEC2a - Taper™ Acetabular System
The C2a-Taper™ Acetabular System is a ceramic on ceramic hip articulating system. The bearing surfaces consist of ceramic femoral heads and acetabular liners.
Sponsors
Biomet Orthopedics, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Hip Score, Radiographic Evaluation | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Survivorship | 10 years |
Countries
United States
Outcome results
None listed