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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: September 3, 2014
Last verified: March 2014

December 19, 2007
September 3, 2014
April 2006
October 2017   (final data collection date for primary outcome measure)
Harris Hip Score, Radiographic Evaluation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00578851 on ClinicalTrials.gov Archive Site
Self-assessment forms [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Same as current
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- 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.
 
Active, not recruiting
34
October 2018
October 2017   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00578851
ORTHO.CR.H021, P050009
No
Biomet, Inc. ( Biomet Orthopedics, LLC )
Biomet Orthopedics, LLC
Not Provided
Study Director: Russell Schenck, Ph.D. Biomet, Inc.
Biomet, Inc.
March 2014

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