A Clinical Investigation of the C2a-Taper™ Acetabular System

This study is currently recruiting participants.

Verified by Biomet, Inc., July 2008

First Received: December 19, 2007 Last Updated: July 3, 2008 History of Changes

Sponsored by:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00578851

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:	Treatment, Open Label, Single Group Assignment
Official Title:	Post Approval Study of the C2a-Taper™ Acetabular System

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Osteonecrosis

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 ]

Estimated Enrollment:	257
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
1	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

Contacts

Contact: Tracy Johnson	1-800-348-9500	tracy.johnson@biometmail.com
Contact: Jarsie Weeks	1-800-348-9500	jarsie.weeks@biomet.com

Locations

United States, Indiana
Biomet Orthopedics, LLC	Recruiting
Warsaw, Indiana, United States, 46581
Contact: Jarsie Weeks 800-348-9500 jarsie.weeks@biomet.com

Sponsors and Collaborators

Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, LLC ( Tracy Johnson )
Study ID Numbers:	202-U-010
Study First Received:	December 19, 2007
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00578851 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Hip Arthroplasty
Hip Arthritis

Study placed in the following topic categories:

Osteonecrosis
Hip Dislocation
Osteoarthritis
Dislocations
Joint Diseases
Rheumatic Diseases
Bone Diseases

Musculoskeletal Abnormalities
Necrosis
Musculoskeletal Diseases
Arthritis
Hip Dysplasia
Congenital Abnormalities
Hip Dislocation, Congenital

Additional relevant MeSH terms:

Necrosis
Pathologic Processes
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases

Arthritis
Rheumatic Diseases
Congenital Abnormalities
Bone Diseases
Musculoskeletal Abnormalities
Hip Dislocation, Congenital

ClinicalTrials.gov processed this record on September 10, 2009