Overview

This trial is active, not recruiting.

Conditions osteoarthritis, avascular necrosis, congenital hip dysplasia, traumatic arthritis
Treatment c2a - taper™ acetabular system
Sponsor Biomet Orthopedics, LLC
Start date April 2006
End date October 2017
Trial size 28 participants
Trial identifier NCT00578851, ORTHO.CR.H021, P050009

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients who receive a THA with the C2a - Taper™ Acetabular System
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.

Primary Outcomes

Measure
Harris Hip Score, Radiographic Evaluation
time frame: 5 years

Secondary Outcomes

Measure
Survivorship
time frame: 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Post Approval Study of the C2a-Taper™ Acetabular System
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Biomet, Inc..