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A Clinical Investigation of the C2a-Taper™ Acetabular System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00578851
First received: December 19, 2007
Last updated: June 19, 2017
Last verified: June 2017
December 19, 2007
June 19, 2017
April 2006
October 2014   (Final data collection date for primary outcome measure)
Harris Hip Score, Radiographic Evaluation [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT00578851 on ClinicalTrials.gov Archive Site
Survivorship [ Time Frame: 10 years ]
Self-assessment forms [ Time Frame: 10 years ]
Not Provided
Not Provided
 
A Clinical Investigation of the C2a-Taper™ Acetabular System
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 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Multi-Center study conducted in the United states on patients who meed the inclusion / exclusion criteria identified in the protocol.
  • Osteoarthritis
  • Avascular Necrosis
  • Congenital Hip Dysplasia
  • Traumatic Arthritis
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.
C2a Taper recipients
Patients who receive a THA with the C2a - Taper™ Acetabular System
Intervention: Device: C2a - Taper™ Acetabular System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
October 2015
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00578851
ORTHO.CR.H021
P050009 ( Other Identifier: FDA )
No
Not Provided
No
Not Provided
Zimmer Biomet ( Biomet Orthopedics, LLC )
Biomet Orthopedics, LLC
Not Provided
Study Director: Kara Mezger Zimmer Biomet
Zimmer Biomet
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP