Comparing standard knee surgery to ROSA-assisted knee surgery
Challenging The TKA Standard Of Care: Patient Specific Surgical Targets As Enabled By The Rosa
This study is testing if a new robotic-assisted knee surgery can help people recover better and feel more satisfied compared to traditional knee surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06267482 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 80 with symptomatic knee osteoarthritis and a varus knee deformity of 0 to 10 degrees.
Not a fit: Patients with active infections, significant medical conditions preventing major surgery, or those with valgus alignment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and higher patient satisfaction for those undergoing knee arthroplasty.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific use of ROSA technology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.