Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06389435

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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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RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques | DecenTrialz