Total Knee Arthoplasty
Conditions
Brief summary
This is a multicenter, prospective and randomized controlled pre-market clinical Trial. Study subjects will be randomized into one of two operative groups: 1) TKA assisted with ROSA® Knee System; 2) TKA with conventional surgical instrumentation.
Detailed description
The objective of this clinical trial is to measure the effectiveness and safety of the ROSA® Knee System in assisting surgeons with bone resections and implant positioning optimization through early clinical and radiographic outcomes compared with conventional surgical instrumentation in total knee arthroplasty (TKA).
Interventions
PROCEDUREROSA assisted TKA
Robotic assisted total knee arthroplasty
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is age between 18 and 85 years old, inclusive; 2. Patient qualifies for a primary TKA based on the investigator's clinical judgement; 3. Patient is a candidate for commercially available Persona® Knee Joint Prosthese which is compatible with the ROSA® Knee System; 4. Patient is willing and able to provide written Informed Consent.
Exclusion criteria
1. Patient planning to receive bilateral TKA surgery within 3 months; 2. Patient who has undergone revision surgery for partial or total knee arthroplasty of the ipsilateral knee； 3. Bone tumor patient who has undergone bilateral TKA; 4. Stable, painless ipsilateral knee arthrodesis within a satisfactory function and position; 5. Patient who has received partial or total knee arthroplasty for the contralateral knee within 6 months prior to scheduled primary TKA; 6. Patient has active, local infection or previous intra-articular infection in the affected joint; 7. Insufficient bone stock on femoral or tibial surfaces; 8. Skeletal immaturity; 9. Osteomalacia or any metabolic disorder which may impair bone formation; 10. Patient has neurologic disorders (e.g. Stroke); 11. Patient hs diseases that could lead to prosthesis instability, failure of prosthesis fixation or postoperative complications (e.g. Arthrodesis, Scoliosis, Lumbar Stenosis) 12. Patient has a 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); 13. Patient has hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation); 14. Patients with severe knee instability caused by incomplete collateral ligaments, cruciate ligaments, and posterolateral structural injury; 15. Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin; 16. Patient has severe angular knee deformity of \>20° varus or \>20° valgus; 17. Patient has a known or suspected sensitivity or allergy to one or more of the implant materials; 18. Patient has other contraindications specified by the implant manufacturer; 19. Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent); 20. In the past 1 month participated in or is participating in clinical trials related to other drugs and medical devices; 21. Any other conditions that the investigator considers inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical axis alignment | 6 weeks (±2 week) postoperatively | Deviation from neutral mechanical axis alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coronal Lower Limb Alignment | 6 weeks (±2 week) postoperatively | Coronal Lower Limb Alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively. |
Countries
China
Outcome results
None listed