Clinical trial NCT04982198: Robotic-assisted Versus Conventional Total Knee Arthroplasty
Official title: Robotic-assisted Versus Conventional Total Knee Arthroplasty: A Multicenter and Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthoplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Mechanical axis alignment
timeFrame: 6 weeks (±2 week) postoperatively
Secondary outcomes:
measure: Coronal Lower Limb Alignment
timeFrame: 6 weeks (±2 week) postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA Hospital
state: Beijing
Study officials:
affiliation: PLA Hospital
name: Yonggang Zhou
role: PRINCIPAL_INVESTIGATOR
References: