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A Clinical Investigation of the C2a-Taper™ Acetabular System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00578851
First Posted: December 21, 2007
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )
  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

Further study details as provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):

Primary Outcome Measures:
  • Harris Hip Score, Radiographic Evaluation [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Survivorship [ Time Frame: 10 years ]

Enrollment: 28
Study Start Date: April 2006
Study Completion Date: October 2015
Primary Completion Date: October 2014 (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 Evaluation- 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578851


Locations
United States, Iowa
Physician's Clinic of Iowa, PCI
Cedar Rapids, Iowa, United States, 52401
United States, Kentucky
Lexington Clinic
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Kara Mezger Zimmer Biomet
  More Information

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00578851     History of Changes
Other Study ID Numbers: ORTHO.CR.H021
P050009 ( Other Identifier: FDA )
First Submitted: December 19, 2007
First Posted: December 21, 2007
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
Hip Arthroplasty
Hip Arthritis

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Necrosis
Hip Dislocation
Hip Dislocation, Congenital
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Dislocations
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities