ROSA Robot Used in Total Knee Replacement Post Market Study
Completed · Not applicable
Conditions studied: Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT03969654
- Run by
- Zimmer Biomet
- People needed
- 181
- Starts
- 2020-05-01
- Expected to finish
- 2023-09-22
- Last updated by the study team
- 2024-05-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patient is a minimum of 18 years of age
- Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and Vanguard knee components implanted in accordance with product labeling
- Patient has participated in this study-related Informed Consent process
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations
You may not qualify if…
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Patient has underwent contralateral UKA or TKA within the last 18 months
- Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
- Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
- Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Where it is running
- Vail-Summit Orthopaedics — Vail, Colorado, United States
- Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC — Westminster, Colorado, United States
- SIU School of Medicine — Springfield, Illinois, United States
- Henry Ford Health System — Detroit, Michigan, United States
- OrthoVirginia Chippenham — North Chesterfield, Virginia, United States
Full record on ClinicalTrials.gov
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