RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
Recruiting now · Not applicable
Conditions studied: Knee Arthroplasty, Total, Robotic-assisted, Osteoarthritis of the Knee
In brief
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
Key facts
- Study ID
- NCT06389435
- Run by
- Danderyd Hospital
- People needed
- 250
- Starts
- 2024-03-04
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2024-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 18 years and older.
- Eligible for TKR according to local guidelines and routines.
- Willingness to participate in the study.
You may not qualify if…
- 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 it is running
- Danderyds Sjukhus — Stockholm, Sweden (enrolling)
Full record on ClinicalTrials.gov
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