Avascular Necrosis of Femoral Condyle, Chronic Osteoarthritis, Knee Pain, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
The primary objective of this study is to collect and compare clinical outcomes and surgical data using the ROSA Total Knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty. The assessments will include: Planned vs actual component positioning; Workflow efficiency; Patient safety based on incidence and frequency of adverse events; Clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.
Interventions
DEVICEPERSONA Total Knee
Primary Total Knee Arthroplasty
Sponsors
Zimmer Biomet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D questionnaire | 1 year | EQ-5D |
| Oxford Knee Score Questionnaire | 1 year | Oxford Knee Score |
Countries
Canada
Outcome results
None listed