Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-04 @ 9:36 AM
Study NCT ID:
NCT00578851
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Investigation of the C2a-Taper™ Acetabular System
Sponsor:
Biomet Orthopedics, LLC
Organization:
Study Overview
Official Title:
Post Approval Study of the C2a-Taper™ Acetabular System
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P050009 | OTHER | FDA | View |