Trials / Completed
CompletedNCT00819481
Post-Market Study of the 3DKnee™ System
Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 229 (actual)
- Sponsor
- Encore Medical, L.P. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.
Detailed description
Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 3DKnee™ System | Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study. |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2014-01-01
- Completion
- 2018-10-01
- First posted
- 2009-01-09
- Last updated
- 2021-03-16
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00819481. Inclusion in this directory is not an endorsement.