Comparing robotic and manual surgery for knee replacement
Robotic Assisted Surgery In Total Knee Replacement Versus Manual Total Knee Arthroplasty: A Randomized Controlled Trial
This study is testing whether robotic surgery is better than traditional surgery for knee replacement in people with knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 2 sites (Gothenburg and 1 other locations) |
| Trial ID | NCT05842538 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of robotic arm-assisted surgery compared to traditional manual surgery in patients undergoing total knee replacement due to knee osteoarthritis. Participants will be randomly assigned to either the robotic-assisted group or the manual surgery group, with their joint awareness assessed using the Forgotten Joint Score over a follow-up period of 24 months. Secondary objectives include measuring pain levels, quality of life, knee function, and revision rates. The study will involve a total of 200 participants across multiple centers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are listed for elective primary total knee replacement due to end-stage osteoarthritis.
Not a fit: Patients with significant knee deformities, those requiring patella resurfacing, or individuals unable to comply with study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and enhanced joint awareness for patients undergoing knee replacement surgery.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, indicating potential benefits over traditional methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Listed for elective primary TKR for end stage osteoarthritis * Suitable candidate for a cruciate retaining TKR (Triathlon prosthesis) * Male or Female, aged 18 years or above (18-80 at the time of listing for surgery). * Able to understand and provide written consent. Exclusion Criteria: * Varus deformity of \> 20 degrees observed by consultant on examination * Patient is unable to comply with the study protocol (incl. refusal for CT scan) * Female participant who is pregnant, lactating or planning pregnancy during the course of the study. * Requires patella resurfacing * Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Where this trial is running
Gothenburg and 1 other locations
- Sahlgrenska University hospital — Gothenburg, Sweden (Recruiting)
- Örebro University Hospital, Department of Medical Sciences — Örebro, Sweden (Recruiting)
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.