Comparing robotic and augmented reality techniques for knee replacement surgery
RobAR Study: Comparison of Image Based Robotic TKA vs Imageless Augmented Reality-Assisted TKA
NA · Medisch Centrum Latem · NCT06891807
This study is testing whether using robotic tools or augmented reality can help doctors place knee replacement parts more accurately for patients with severe knee arthritis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Medisch Centrum Latem (other) |
| Locations | 1 site (Sint-Martens-Latem, Oost-Vlaanderen) |
| Trial ID | NCT06891807 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of two surgical techniques for total knee arthroplasty: one using robotic assistance and the other utilizing augmented reality for instrument placement. Both methods aim to enhance the precision of prosthesis component placement during surgery. Patients diagnosed with advanced knee osteoarthritis, who are candidates for knee replacement surgery, will be enrolled to assess the effectiveness of these innovative approaches. The goal is to optimize and personalize patient care in knee arthroplasty procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with advanced knee osteoarthritis who are scheduled for primary total knee arthroplasty.
Not a fit: Patients with revision knee surgery, significant comorbidities affecting rehabilitation, or those who have recently undergone knee surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing knee replacement surgery.
How similar studies have performed: Other studies have shown promising results with robotic and augmented reality-assisted surgical techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects from 18 years up to 85 years old * Patients eligible and planned for a primary Total Knee Arthroplasty * Patients willing to sign the informed consent form (ICF) for participating in this study * Indication of surgery is primary osteoarthritis Exclusion Criteria: * Revision knee surgery * Other medical conditions contributing to the rehabilitation process of the TKA according to the surgeon, such as Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident * The patient received a TKA within the last three months or has a TKA planned in the next three months, for the contralateral knee * Patient is participating in another clinical trial * Patient is not able to understand Dutch, French or English * Patients who did not meet all of the inclusion criteria
Where this trial is running
Sint-Martens-Latem, Oost-Vlaanderen
- Medisch Centrum Latem — Sint-Martens-Latem, Oost-Vlaanderen, Belgium (RECRUITING)
Study contacts
- Study coordinator: Philippe Van Overschelde, MD, MSc, MBA
- Email: secretariaat.heupknie@azmmsj.be
- Phone: +9 220 88 68
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: Knee Osteoarthritis, Total Knee Arthroplasty\, Total Knee Replacement Surgery, Total Knee Arthroplasty, Assistive Technologies, Robotics, Augmented Reality