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Using ROSA for Challenging The TKA Standard of Care

NCT06267482 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-14

No results posted yet for this study

Summary

This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.

1. Standard of care medial parapetallar approach (Control)
2. ROSA PSA medial parapetallar approach
3. ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels.

Conditions

Interventions

PROCEDURE

ROSA PSA Parapatellar Approach

This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be the same as the standard of care (medial parapatellar approach).

PROCEDURE

ROSA PSA Subvastus Approach

This intervention will consist of using the ROSA alongside patient-specific alignment. The knee incision will be an alternative, quad-sparring, subvastus approach.

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Brent Lanting, PhD · London Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267482 on ClinicalTrials.gov