Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT00604734
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2007-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Clinical Study On A Total Hip Resurfacing System
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
A Prospective Clinical Study On A Total Hip Resurfacing System
Status:
COMPLETED
Status Verified Date:
2019-02
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 prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
Detailed Description:
The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces.
The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.
The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.
Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.
Primary endpoints:
* Total Harris hip score
* Device revisions or removals
Secondary endpoints:
* Total Harris hip score
* Radiographic changes as evidenced by:
I. Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.
The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.
Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.
Primary endpoints:
* Total Harris hip score
* Device revisions or removals
Secondary endpoints:
* Total Harris hip score
* Radiographic changes as evidenced by:
I. Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
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?: