NCT00578851

A Clinical Investigation of the C2a-Taper™ Acetabular System

Post Approval Study of the C2a-Taper™ Acetabular System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Biomet Orthopedics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Osteoarthritis
• Avascular Necrosis
• Congenital Hip Dysplasia
• Traumatic Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2014-10-01
• Completion: 2015-10-01
• First posted: 2007-12-21
• Last updated: 2017-06-21

Locations

2 sites across 1 country: United States