Actively Recruiting
RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
Led by Danderyd Hospital · Updated on 2024-04-29
250
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
Sponsors
D
Danderyd Hospital
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older.
- Eligible for total knee replacement according to local guidelines and routines.
- Willingness to participate in the study.
You will not qualify if you...
- Patients with extreme malalignment necessitating special implants or techniques.
- Patients unfit for surgery due to other medical reasons.
- Patients deemed unsuitable to participate due to alcohol or substance abuse.
- Patients unable to complete required patient-reported outcome measures.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Danderyds Sjukhus
Stockholm, Sweden, 18288
Actively Recruiting
Research Team
O
Olof Sköldenberg, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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