Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-01-04 @ 8:39 AM
Study NCT ID:
NCT03672916
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty: A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Status:
COMPLETED
Status Verified Date:
2025-01
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:
This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
Detailed Description:
The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System.
A total of 200 patients are planned to be enrolled in this study which will last 12 years (2 year enrollment plus 10 years follow-up) with the follow-up visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.
This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System.
A total of 200 patients are planned to be enrolled in this study which will last 12 years (2 year enrollment plus 10 years follow-up) with the follow-up visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: