Comparing two surgical techniques for knee replacement in osteoarthritis patients
Robotic Assisted Surgery Comparing Personalized Alignment Versus Mechanical Alignment of Total Knee Arthroplasty - A Randomized Controlled Trial
This study is testing two different surgical methods for knee replacement in people with osteoarthritis to see which one leads to better results and satisfaction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Helse Møre og Romsdal HF Government |
| Locations | 1 site (Kristiansund, Møre and Romsdal) |
| Trial ID | NCT06507046 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of two different alignment techniques in total knee arthroplasty for patients with knee osteoarthritis. The classical mechanical alignment aims for a neutral knee position, while the newer kinematical alignment focuses on restoring the patient's natural anatomy, even if it results in a non-neutral position. Patients will undergo robotic knee surgery and be assessed clinically and through specialized CT scans to evaluate the longevity of the implants and overall outcomes. The study aims to provide insights into which technique may offer better results in terms of implant stability and patient satisfaction.
Who should consider this trial
Good fit: Ideal candidates are individuals with femoro-tibial or patello-femoral osteoarthritis (Kellgren-Lawrence grade 2-4) experiencing persistent pain and referred for primary total knee arthroplasty.
Not a fit: Patients with serious psychiatric disorders, dementia, or those requiring walking aids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and longer-lasting knee implants for patients with osteoarthritis.
How similar studies have performed: While some studies have explored similar alignment techniques, results have been mixed, indicating that this approach is still being evaluated for its effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • femoro-tibial or patello-femoral osteoarthritis (Kellgren-Lawrence, K-L) grade 2-4 with persistent pain, referred to Kristiansund Hospital for primary TKA Exclusion Criteria: * serious psychiatric disorders * dementia * drug abuse * patients not able to speak and read Norwegian language making them noncompliant or unable to perform an informed consent * Patients with ongoing cancer therapy * Patients with ASA (The American Society of Anesthesiologists physical status class risk stratification system) classification \>3 * Patients in the need of walking aid devices * Patients in need of primary revision arthroplasty or more than 15 degrees of varus or 5 degrees of valgus on preoperative HKA images.
Where this trial is running
Kristiansund, Møre and Romsdal
- Kristiansund Hospital, Møre and Romsdal Hospital Trust — Kristiansund, Møre and Romsdal, Norway (Recruiting)
Study contacts
- Study coordinator: Myrhle Hoel, Nurse
- Email: Myrthle.Slettvag.Hoel@helse-mr.no
- Phone: 71120000
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.