Trials / Completed
CompletedNCT01473134
Safety and Efficacy of the Oxford Cementless Partial Knee System
A Randomized Clinical Study to Compare the Safety and Efficacy of the Oxford Cementless Partial Knee System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 320 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Oxford Cementless Partial Knee | Oxford Partial Knee applied without bone cement. |
| DEVICE | Oxford Cemented Partial Knee | Oxford Partial Knee applied with bone cement. |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2020-11-30
- Completion
- 2021-11-30
- First posted
- 2011-11-17
- Last updated
- 2025-08-11
- Results posted
- 2024-09-19
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01473134. Inclusion in this directory is not an endorsement.