Robotic-assisted Versus Conventional Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Total Knee Arthoplasty
• Interventions: Procedure: ROSA assisted TKA

• Registration Number: NCT04982198
• Lead Sponsor: Zimmer Biomet

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).

Study Timeline

• Study Start: 2021-07-07
• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-29
• Primary Completion: 2022-12-30
• Study Completion: 2023-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TKA with conventional surgical instrumentation	ROSA assisted TKA	TKA with conventional surgical instrumentation
TKA assisted with ROSA® Knee System	ROSA assisted TKA	TKA assisted with ROSA® Knee System

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

PLA Hospital; 🇨🇳 Beijing, Beijing, China