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: July 14, 2014
Last verified: March 2014
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Approval Study of the C2a-Taper™ Acetabular System

Resource links provided by NLM:


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: October 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
C2a Taper recipients
Patients who receive a THA with the C2a - Taper™ Acetabular System
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.

Detailed Description:

Study Design:

Phase 1

Sites will collect the following types of data:

Clinical-Total Harris Hip Score, Radiographic- 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Multi-Center study conducted in the United states on patients who meed the inclusion / exclusion criteria identified in the protocol.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Russell Schenck, Ph.D. Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00578851     History of Changes
Other Study ID Numbers: ORTHO.CR.H021, P050009
Study First Received: December 19, 2007
Last Updated: July 14, 2014
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
Hip Dislocation
Joint Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Pathologic Processes
Bone Diseases
Rheumatic Diseases
Dislocations
Wounds and Injuries
Hip Injuries

ClinicalTrials.gov processed this record on July 23, 2014