RecruitingNot ApplicableNCT06839807

DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting

Adequately Diagnosing Total Knee Arthroplasty Loosening: A Randomized Controlled Trial Evaluating the AtMoves Knee System in a Routine Clinical Setting


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

124 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of the clinical trial is to evaluate the efficacy of the AtMoves Knee System in the clinical diagnostic process of aseptic loosening in patients with a knee prosthesis. The main question it aims to answer is: Does the use of the AtMoves Knee System reduce the percentage of failed outcomes? A "failed outcome" is defined as a change in the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS-PS) that is lower than the minimal clinically important difference at 12 months. Researchers will compare two groups: The first group will undergo an additional CT scan using the AtMoves Knee System. The second group will not undergo these scans. Both groups are allowed to undergo additional diagnostic measures. Researchers will compare the percentage of "failed outcomes" between these groups. During the one-year follow-up, participants in both groups will be asked to fill out questionnaires.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called AtMoves Knee System for people with aseptic loosening, aseptic loosening of orthopaedic hardware, and other related conditions. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAtMoves Knee System

The AtMoves Knee Stystem is a loading device that is able to exert force in varus and valgus. when these forces are applied during a CT-scan micromotions of the tibial component of the total knee prosthesis can be detected.


Locations(7)

St. Maartenskliniek

Nijmegen, Gelderland, Netherlands

Zuyderland Ziekenhuis

Heerlen, Limburg, Netherlands

Amphia ziekenhuis

Breda, North Brabant, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

OCON

Hengelo, Overijsel, Netherlands

NoordWest Ziekenhuisgroep

Alkmaar, Netherlands

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

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NCT06839807


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