A Clinical Investigation of the C2a-Taper™ Acetabular System

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00578851
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Completed
Phase	N/A
Start date	April 2006
Completion date	October 2015

View Details

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