Robotic-assisted Versus Conventional Total Knee Arthroplasty

Zimmer Biomet

Status: Completed

Conditions: Total Knee Arthoplasty

Treatments: Procedure: ROSA assisted TKA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04982198

CEA2019-05K

Details and patient eligibility

About

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.

Full 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).

Enrollment: 99 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

TKA assisted with ROSA® Knee System

Experimental group

Description:

TKA assisted with ROSA® Knee System

Treatment:

Procedure: ROSA assisted TKA

TKA with conventional surgical instrumentation

Active Comparator group

Description:

TKA with conventional surgical instrumentation

Treatment:

Procedure: ROSA assisted TKA