ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Pain
- Sponsor
- Zimmer Biomet
- Enrollment
- 181
- Locations
- 5
- Primary Endpoint
- Post-Operative Pain & Satisfaction
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Post-Operative Pain & Satisfaction
Time Frame: 6 weeks, 3 months, and 1 year
Post-Operative Pain \& Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.
Clinical Performance
Time Frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.
Total Range of Motion
Time Frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop
Oxford
Time Frame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).