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Robotic-assisted Versus Conventional Total Knee Arthroplasty

Sponsor
Zimmer Biomet (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04982198
Collaborator
(none)
156
Enrollment
1
Location
2
Arms
17.8
Anticipated Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: ROSA assisted TKA
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Robotic-assisted Versus Conventional Total Knee Arthroplasty: A Multicenter and Randomized Controlled Clinical Trial
Actual Study Start Date :
Jul 7, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: TKA assisted with ROSA® Knee System

TKA assisted with ROSA® Knee System

Procedure: ROSA assisted TKA
Robotic assisted total knee arthroplasty
Active Comparator: TKA with conventional surgical instrumentation

TKA with conventional surgical instrumentation

Procedure: ROSA assisted TKA
Robotic assisted total knee arthroplasty

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 PLA Hospital Beijing Beijing China 100048

Sponsors and Collaborators

  • Zimmer Biomet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT04982198
Other Study ID Numbers:
  • CEA2019-05K
First Posted:
Jul 29, 2021
Last Update Posted:
Aug 9, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 9, 2021