A Clinical Investigation of the C2a-Taper™ Acetabular System

Verified by: Biomet, Inc., October 2011
First Received: December 19, 2007 | Last Updated: October 17, 2011 | Phase: N/A | Start Date: April 2006
Overall Status: Active, not recruiting | Estimated Enrollment: 34
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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...

Brief Summary

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: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • 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: C2a Taper recipients

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Biomet Orthopedics, LLC Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00578851