Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study
NCT03391323 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218
Last updated 2026-04-29
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
- Osteoarthritis
- Osteoarthritis, Knee
- Joint Disease
Interventions
- DEVICE
-
Medacta GMK Sphere® Medial-Pivot Knee Prosthesis
- DEVICE
-
Medacta GMK PS Posterior Stabilized Knee Prosthesis
Sponsors & Collaborators
-
Medacta USA
collaborator INDUSTRY -
David F. Scott, MD
lead OTHER
Principal Investigators
-
David Scott, MD · Spokane Joint Replacement Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-04-30
- Primary Completion
- 2023-11-27
- Completion
- 2023-11-27
- FDA Device
- Yes
Countries
- United States
Study Locations
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