Robotic-assisted Versus Conventional Total Knee Arthroplasty

NCT04982198 | Completed

• 1 other identifier: CEA2019-05K
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthoplasty

Outcome Measures

Primary Outcomes (1)

• Mechanical axis alignment

  Deviation from neutral mechanical axis alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively.

  6 weeks (±2 week) postoperatively

Secondary Outcomes (1)

• Coronal Lower Limb Alignment

  6 weeks (±2 week) postoperatively

Study Arms (2)

TKA assisted with ROSA® Knee System

EXPERIMENTAL

TKA assisted with ROSA® Knee System

Procedure: ROSA assisted TKA

TKA with conventional surgical instrumentation

ACTIVE COMPARATOR

TKA with conventional surgical instrumentation

Procedure: ROSA assisted TKA

Interventions

ROSA assisted TKA PROCEDURE

Robotic assisted total knee arthroplasty

TKA assisted with ROSA® Knee System; TKA with conventional surgical instrumentation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is age between 18 and 85 years old, inclusive;
• Patient qualifies for a primary TKA based on the investigator's clinical judgement;
• Patient is a candidate for commercially available Persona® Knee Joint Prosthese which is compatible with the ROSA® Knee System;
• Patient is willing and able to provide written Informed Consent.

You may not qualify if:

• Patient planning to receive bilateral TKA surgery within 3 months;
• Patient who has undergone revision surgery for partial or total knee arthroplasty of the ipsilateral knee；
• Bone tumor patient who has undergone bilateral TKA;
• Stable, painless ipsilateral knee arthrodesis within a satisfactory function and position;
• Patient who has received partial or total knee arthroplasty for the contralateral knee within 6 months prior to scheduled primary TKA;
• Patient has active, local infection or previous intra-articular infection in the affected joint;
• Insufficient bone stock on femoral or tibial surfaces;
• Skeletal immaturity;
• Osteomalacia or any metabolic disorder which may impair bone formation;
• Patient has neurologic disorders (e.g. Stroke);
• Patient hs diseases that could lead to prosthesis instability, failure of prosthesis fixation or postoperative complications (e.g. Arthrodesis, Scoliosis, Lumbar Stenosis)
• 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);
• Patient has hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation);
• Patients with severe knee instability caused by incomplete collateral ligaments, cruciate ligaments, and posterolateral structural injury;
• Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin;

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

PLA Hospital

Beijing, Beijing Municipality, 100048, China

Location

Study Officials

• Yonggang Zhou

  PLA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: July 7, 2021
• Primary Completion: December 30, 2022
• Study Completion: May 31, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)