Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 1:37 PM
Study NCT ID:
NCT03409666
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2018-01-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Status:
COMPLETED
Status Verified Date:
2022-06
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:
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.
Detailed Description:
A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.
All potential study subjects will be required to participate in the Informed Consent process.
All potential study subjects will be required to participate in the Informed Consent process.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: