Trials / Completed
CompletedNCT03391323
Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study
Medacta GMK Sphere® Medial-Pivot, Cruciate Substituting vs. Medacta GMK PS Posterior Stabilized Kne vs. OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- David F. Scott, MD · Academic / Other
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The study is a prospective, randomized comparison of total knee arthroplasty with the Medacta GMK Sphere® knee compared to the Medacta GMK PS knee, with comparison to data from previous trials of similar study design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medacta GMK Sphere® Medial-Pivot Knee Prosthesis | |
| DEVICE | Medacta GMK PS Posterior Stabilized Knee Prosthesis |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2023-11-27
- Completion
- 2023-11-27
- First posted
- 2018-01-05
- Last updated
- 2024-11-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03391323. Inclusion in this directory is not an endorsement.