NCT06389435 RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
| NCT ID | NCT06389435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danderyd Hospital |
| Condition | Knee Arthroplasty, Total |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-03-04 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-03-04 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale for conducting the study: The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events. Study design: Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques. Study population: Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study. Number of patients: 400 Inclusion criteria: Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study. Exclusion criteria: Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons. Primary outcome variables: The Forgotten Joint Score (FJS) at 2 years after surgery
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06389435 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Arthroplasty, Total. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06389435 currently recruiting?
Yes, NCT06389435 is actively recruiting participants. Contact the research team at olof.skoldenberg@ki.se for enrollment information.
Where is the NCT06389435 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06389435 clinical trial?
NCT06389435 is sponsored by Danderyd Hospital. The trial plans to enroll 250 participants.