ROSA Total Knee Investigational Testing Authorization Study
TerminatedNot applicableNCT03970629
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Brief summary (from the registry)
This is a prospective, single-center 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 Total Knee components using the ROSA Total Knee Robotic System or conventional instrumentation.
Study details
- Official title
- ROSA Total Knee Investigational Testing Authorization Study: Prospective Single Center Study of the ROSA Total Knee System
- Conditions
- Knee Pain
- Chronic Osteoarthritis
- Avascular Necrosis of Femoral Condyle
- Moderate Varus, Valgus or Flexion Deformities
- Rheumatoid Arthritis
- Interventions
- Device: PERSONA Total Knee
- Sponsor
- Zimmer Biomet
- Start date
- 2019-06-20
- Primary completion
- 2021-11-23
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patient is a minimum of 18 years of age 2. Pre-op component positioning and sizing plan prior to surgery 3. Independent of study participation, patient is a candidate for primary TKA using the commercially available Persona knee components implanted in accordance with product labeling 4. Patient has participated in this study-related Informed Consent process 5. Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form 6. Patient is willing and able to complete scheduled study procedures and follow-up evaluations Exclusion Criteria: 1. Patient is currently participating in any other surgical intervention studies or pain management studies 2. Patient has underwent contralateral UKA or TKA within the last 18 months 3. 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) 4. Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation) 5. Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) 6. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03970629