Finished
ROSA Robot Used in Total Knee Replacement Post Market Study
NCT03969654 · Zimmer Biomet · Updated 3 May 2024
- What is being tested
- PERSONA Total Knee; Vanguard Total Knee; NexGen Total Knee
- For
- Knee Pain; Chronic Osteoarthritis; Avascular Necrosis of the Femoral Condyle; Moderate Varus, Valgus or Flexion Deformities; Rheumatoid Arthritis
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 181 people. The full rules are on the registry page.
- Where
- United States (5 sites)
- When
- Starts or started 1 May 2020, ends 22 Sept 2023. Registered 31 May 2019.
- Results
- Posted on the registry on 3 May 2024.
In the researchers' words
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.
Sites
- Vail-Summit OrthopaedicsVail, Colorado, United States
- Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLCWestminster, Colorado, United States
- SIU School of MedicineSpringfield, Illinois, United States
- Henry Ford Health SystemDetroit, Michigan, United States
- OrthoVirginia ChippenhamNorth Chesterfield, Virginia, United States