NCT06267482 Using ROSA for Challenging The TKA Standard of Care
| NCT ID | NCT06267482 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-04-16 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 * Intraoperative findings of insufficient contact between the implant and the bone surface * Body Mass Index of 40 or more
Contact & Investigator
Brent Lanting, PhD
PRINCIPAL INVESTIGATOR
London Health Sciences Center
Frequently Asked Questions
Who can join the NCT06267482 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06267482 currently recruiting?
Yes, NCT06267482 is actively recruiting participants. Contact the research team at lyndsay.somerville@lhsc.on.ca for enrollment information.
Where is the NCT06267482 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06267482 clinical trial?
NCT06267482 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Brent Lanting, PhD at London Health Sciences Center. The trial plans to enroll 90 participants.