Recruiting

ROSA

Sponsor:

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

Code:

NCT06267482

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

ROSA PSA Parapatellar Approach

ROSA PSA Subvastus Approach

Study Details

Brief 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

Knee Osteoarthritis

Study ID

NCT06267482

Start date

Apr 16, 2024

Status verified date

May, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Varus knee deformity of 0 to 10 degrees
  • Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent

Exclusion Criteria:

  • Active or prior infection
  • Medical condition precluding major surgery
  • Predominantly inflammatory arthropathy
  • Patellectomy
  • PCL deficiency
  • Major coronal plane deformity
  • Prior trauma to the tibia or femur resulting in malalignment, canal occlusion, or open reduction and internal fixation
  • Valgus alignment
  • Neurologic condition limiting mobility
  • Bone defects requiring augments, cones and/or stemmed implants

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Control

Standard of care medial parapetallar approach

active comparator: ROSA PSA Parapatellar Approach

Arm using the ROSA with PSA and medial parapetallar approach

active comparator: ROSA PSA Subvastus Approach

Arm using the ROSA with PSA and medial subvastus approach

Interventions

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).

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.

Primary outcome measure

  • Functional Outcome - Weight-bearing CT scan [ Time Frame: Pre-operation, 1-3 days post-op, 6-weeks post-op, and 1-year post-op ]
  • Functional Outcome - 3D Ultrasound [ Time Frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op ]
  • Functional Outcome - Timed Up and Go test [ Time Frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op ]
  • Patient health status - Knee Society Score [ Time Frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op ]
  • Patient health status - EuroQuol Survey [ Time Frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op ]
  • Patient health status - Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op ]
  • Patient health status - Western Ontario and McMaster Universities Arthritis Index [ Time Frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op ]
  • Patient health status - Global Assessment [ Time Frame: Pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op ]

Central Contacts and Locations

Central contacts

Lyndsay Somerville, PhD

(519) 685-8500lyndsay.somerville@lhsc.on.ca

Locations

University Hospital

Recruiting

London, Ontario, Canada

More Information

Sponsor

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

Last update posted

May 14, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-05-14.