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RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

NCT06389435 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-04-29

No results posted yet for this study

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

Conditions

  • Knee Arthroplasty, Total
  • Robotic-assisted
  • Osteoarthritis of the Knee

Interventions

PROCEDURE

Patients will be randomized to undergo TKR or RTKR

Total knee replacement (control group)

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Stockholm South General Hospital

    collaborator OTHER

  • Danderyd Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2027-01-31
Completion
2028-01-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06389435 on ClinicalTrials.gov