Comparing standard knee surgery to ROSA-assisted knee surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective, randomized controlled trial that compares conventional total knee arthroplasty (TKA) with ROSA-assisted TKA using two different surgical approaches. Participants will be randomly assigned to one of three groups: standard medial parapatellar approach, ROSA PSA medial parapatellar approach, or ROSA PSA medial subvastus approach. The study will follow patients for one year post-surgery, assessing various outcomes including functional performance, patient-reported satisfaction, and inflammatory responses. The goal is to determine if the ROSA technology can improve surgical outcomes and patient satisfaction compared to the standard approach.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Brent Lanting, PhD — London Health Sciences Center
• Study coordinator: Lyndsay Somerville, PhD
• Email: lyndsay.somerville@lhsc.on.ca
• Phone: (519) 685-8500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.