Comparing robotic-assisted and conventional knee replacement techniques
ROCKETS: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques in a Randomized, Multicenter, Preference-tolerant Study
This study is testing if robotic-assisted knee replacement surgery helps adults recover better and have fewer problems compared to traditional knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danderyd Hospital Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06389435 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) versus conventional Total Knee Replacement (TKR). It aims to determine if RTKR offers improved precision and better patient outcomes, as measured by the Forgotten Joint Score and other patient-reported outcome measures. The study is designed as a multicenter, randomized, controlled trial with two treatment arms, focusing on adult patients eligible for knee replacement surgery. Secondary endpoints include activity levels, implant positioning accuracy, and adverse event rates.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are eligible for total knee replacement.
Not a fit: Patients with extreme malalignment requiring special implants or those unfit for surgery due to other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced healthcare costs for patients undergoing knee replacement.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgical techniques, suggesting potential benefits in precision and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and older. * Eligible for TKR according to local guidelines and routines. * Willingness to participate in the study. Exclusion Criteria: * Patients with extreme malalignment necessitating special implants or techniques. * Patients unfit for surgery due to other medical reasons. * Patients who, for other reason such as alcohol or substance abuse, is deemed unsuitable to participate in the study. * Patients who, for other reasons can't fulfill the required patient recorded outcome measures
Where this trial is running
Stockholm
- Danderyds Sjukhus — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Olof Sköldenberg, MD, PhD
- Email: olof.skoldenberg@ki.se
- Phone: 46+700891253
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.