Official Title: “Post Approval Study of the C2a-Taper™ Acetabular System”

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 Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment

Study Primary Completion Date: April 2013

Intervention(s) in this Clinical Trial

• Device: C2a - 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.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1

Primary Measures

• Harris Hip Score, Radiographic Evaluation
  • Time Frame: 5 years
    Safety Issue?: No

Secondary Measures

• Self-assessment forms
  • Time Frame: 10 years
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Overall Contact: Tracy Johnson 1-800-348-9500 tracy.johnson@biometmail.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00578851

Study ID Number: 202-U-010

ClinicalTrials.gov Identifier: NCT00578851

Health Authority: United States: Food and Drug Administration