Comparing robotic and custom knee replacements for osteoarthritis
Prospective Randomized Controlled Trial of Functionally Aligned Robotically Assisted Total Knee Arthroplasty vs Patient Specific Custom Made Total Knee Arthroplasty
This study is testing whether robotic knee replacements work better than custom-made ones for people with knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Austrian Workers Compensation Board Styria Academic / other |
| Locations | 2 sites (Graz, Styria and 1 other locations) |
| Trial ID | NCT06280352 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the outcomes of robotic-assisted functionally aligned total knee arthroplasty with custom-made total knee arthroplasty in patients suffering from knee osteoarthritis. The study will evaluate which approach yields better clinical results, patient satisfaction, and operating room efficiency. Participants will be monitored for two years following their surgery to assess these outcomes.
Who should consider this trial
Good fit: Ideal candidates are males or non-pregnant females aged 40 to 90 who require a primary total knee replacement due to osteoarthritis.
Not a fit: Patients with a history of knee reconstruction, severe obesity, or significant knee deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient satisfaction for those undergoing knee replacement surgery.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, suggesting potential benefits, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \- The patient is a male or non-pregnant female between the ages of 40 and 90 years * The patient requires a primary total knee replacement * Patient is deemed appropriate for a cruciate retaining knee replacement * The patient has a primary diagnosis of osteoarthritis (OA) * The patient has intact collateral ligaments * The patient is able to undergo CT scanning of the affected limb * The patient has signed the study specific, ethics-approved, informed consent document * The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations Exclusion Criteria: * \- The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint * Patient has had a previous osteotomy around the knee * The patient is morbidly obese (BMI \> 41) * The patient has a deformity which will require the use of stems, wedges or augments * The patient has a varus deformity ≥ 15° * The patient has a valgus deformity \>3° * The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device * The patient is unable to speak German * The patient is pregnant
Where this trial is running
Graz, Styria and 1 other locations
- AUVA UKH Steiermark Standort Graz — Graz, Styria, Austria (Recruiting)
- AUVA UKH Steiermark Standort Kalwang — Kalwang, Styria, Austria (Recruiting)
Study contacts
- Study coordinator: Antonio Klasan, MD, PhD, EMBA
- Email: klasan.antonio@me.com
- Phone: +436765085920
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.