Robotic-assisted Versus Conventional Total Knee Arthroplasty

NCT ID: NCT04982198

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2023-05-31

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).

Conditions

Total Knee Arthoplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TKA assisted with ROSA® Knee System

TKA assisted with ROSA® Knee System

Group Type: EXPERIMENTAL

ROSA assisted TKA

Intervention Type: PROCEDURE

Robotic assisted total knee arthroplasty

TKA with conventional surgical instrumentation

TKA with conventional surgical instrumentation

Group Type: ACTIVE_COMPARATOR

ROSA assisted TKA

Intervention Type: PROCEDURE

Robotic assisted total knee arthroplasty

Interventions

ROSA assisted TKA

Robotic assisted total knee arthroplasty

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yonggang Zhou

Role: PRINCIPAL_INVESTIGATOR

PLA Hospital

Locations

PLA Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CEA2019-05K

Identifier Type: -

Identifier Source: org_study_id