Comparing robotic and conventional knee replacement surgeries
Conventional vs. Robotic-Assisted Total Knee Arthroplasty: A Prospective, Randomized Trial of Clinical, Functional, and Radiographic Outcomes
NA · Columbia University · NCT03519269
This study tests if robotic knee replacement surgery works better than traditional knee surgery for people aged 40 to 85 with severe knee arthritis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03519269 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of robotic-assisted total knee arthroplasty (TKA) compared to conventional TKA in patients aged 40 to 85 with end-stage knee osteoarthritis. The aim is to determine if the robotic approach can improve surgical accuracy and patient outcomes. Participants will receive the same postoperative care and implants, and their outcomes will be assessed through clinical evaluations and imaging. The study seeks to address the potential advantages of newer robotic technology in knee surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 85 with end-stage knee osteoarthritis who have not responded to at least 12 weeks of nonoperative management.
Not a fit: Patients with a history of inflammatory arthritis, prior knee surgeries, or significant deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing knee replacement surgery.
How similar studies have performed: Previous studies have shown success with robotic-assisted techniques in partial knee replacements, but this specific application for total knee replacements is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age between 40 and 85 * body mass index (BMI) less than 40.0 kg/m\^2 * end-stage knee osteoarthritis (Kellgren and Lawrence grade 4) * failure of a minimum 12 weeks of nonoperative management * English fluency Exclusion Criteria: * history of inflammatory arthropathy in the same knee * history of prior open knee surgery in the same knee * history of prior osteotomy or periarticular fracture * deformity \> 15 degrees from a neutral mechanical axis * gross ligamentous incompetence of the medial or lateral collateral ligaments * musculoskeletal involvement beyond unilateral knee osteoarthritis significantly limiting their function * unwillingness or inability to participate in the proposed study protocol and follow-up
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Herbert John Cooper, MD — Columbia University
- Study coordinator: Jacqueline Lenahan, BS
- Email: jl5092@cumc.columbia.edu
- Phone: 212-305-8193
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.
Conditions: Osteoarthritis, Knee, total knee replacement, robotic surgery