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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
124
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.
St. Maartenskliniek
Nijmegen, Gelderland, Netherlands
NOT_YET_RECRUITINGZuyderland Ziekenhuis
Heerlen, Limburg, Netherlands
NOT_YET_RECRUITINGAmphia ziekenhuis
Breda, North Brabant, Netherlands
NOT_YET_RECRUITINGAmsterdam UMC
Amsterdam, North Holland, Netherlands
RECRUITINGOCON
Hengelo, Overijsel, Netherlands
NOT_YET_RECRUITINGNoordWest Ziekenhuisgroep
Alkmaar, Netherlands
NOT_YET_RECRUITINGElisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
NOT_YET_RECRUITINGFailed Outcome
The primary outcome measure is the status of the outcome of the treatment as "failed outcome" at 12 months as determined by a change in KOOS-PS (Knee Injury and Osteoarthritis Outcome Score-Physical function Short form) that is less than the minimal clinically important difference (MCID) compared to baseline KOOS-PS (MCID is set to 15). The KOOS-PS gives a score from 0-100 with higher scores reflecting better physical function.
Time frame: 12 months
Revision surgery
The number of participants between the two arms that undergo revision surgery in the 12 months follow up period despite the initial decision (based on the diagnostic pathway) to not perform revision surgery.
Time frame: 12 months
Number of Diagnostic activities
The number and types of diagnostic activities until the final diagnostic treatment decision is made in all subjects
Time frame: until the final diagnostic decision (up to six months)
Cost of diagnostic activities
The cost of diagnostic activities until the final diagnostic treatment decision is made in all subjects. For cost-effectiveness evaluation. This will be measured using a version of the iMTA Medical Consumption Questionnaire (iMCQ).
Time frame: Upon the final diagnostic decision (up to six months).
Medical consumption after diagnosis
Medical consumption costs after final diagnosis and treatment until the end of follow-up (1 year). Measured using the iMTA Medical Consumption Questionnaire at 1 year follow-up.
Time frame: 1 Year
Societal productivity loss after diagnosis
Societal productivity loss after final diagnosis and treatment until the end of follow-up (1 year). Measured using the iMTA Productivity Cost Questionnaire at 1 year follow-up.
Time frame: 1 Year
Subject satisfaction intervention group
Satisfaction of undergoing the AtMoves Knee System, measured in trial subjects randomized in the intervention arm. Measured by a short questionnaire including pain during- and after the scan (10 point numeric rating scale), subjective satisfaction of the scan (10 point numeric rating scale), and open field option for any comments on satisfaction on the day of the scan.
Time frame: Day of CT-scan using the AtMoves Knee system (day 0)
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