Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT01473134
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of the Oxford Cementless Partial Knee System
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
A Randomized Clinical Study to Compare the Safety and Efficacy of the Oxford Cementless Partial Knee System
Status:
COMPLETED
Status Verified Date:
2024-09
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 clinical investigation is to evaluate the safety and effectiveness of the Oxford® Cementless Partial Knee System. The Oxford® Cementless Partial Knee System is intended to help the patients diagnosed with osteoarthritis or avascular necrosis gain mobility and decrease pain. All of the risks common to a conventional joint replacement are possible with this device as certain risks are associated with any invasive procedures. The study is designed to document and compare the clinical and radiographic results of the Oxford® Cementless Partial Knee System to those of the cemented Oxford® Partial Knee System (control treatment).
Detailed Description:
Prospectively controlled, randomized Investigational study. Patients are asked to come in pre-operatively, surgery, 6 weeks, 6 months, 1 year, 2 years and annually until the last patient reaches their 2 year visit. Product has not been cleared for use.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ORTHO.CR.US30 | OTHER | Biomet | View |