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A Clinical Investigation of the C2a-Taper™ Acetabular System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00578851
First received: December 19, 2007
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  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.


Condition Intervention
Osteoarthritis
Avascular Necrosis
Congenital Hip Dysplasia
Traumatic Arthritis
 Device: C2a - Taper™ Acetabular System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post Approval Study of the C2a-Taper™ Acetabular System

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Harris Hip Score, Radiographic Evaluation [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-assessment forms [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: April 2006
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
C2a Taper recipients 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578851

Locations
United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00578851     History of Changes
Other Study ID Numbers: 202-U-010
Study First Received: December 19, 2007
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Hip Arthroplasty
Hip Arthritis

Additional relevant MeSH terms:
Arthritis
Hip Dislocation, Congenital
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
 Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Pathologic Processes
Bone Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013