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.
Age 18 years or older.
Subjects must have underwent either unilateral or bilateral TKA surgery.
Aseptic loosening is one of the differential diagnoses of the treating orthopaedic surgeon
The treating Orthopaedic Surgeon is uncertain of the diagnosis after anamnesis, physical examination and conventional x-ray.
A clear other cause for complaints other than aseptic loosening (e.g. septic loosening, neuropathic pain, non-consolidated peri-prosthetic fracture of the bone around the TKA)
Surgical interventions of the index knee in the year prior to the start of the complaints associated with TKA loosening.
Posttraumatic or congenital deformation of the leg for which the loading device does not fit.
Pregnancy or suspected pregnancy.
Parallel
AtMoves Knee System
DeviceThe 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.
Failed 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.
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.
Number of Diagnostic activities
The number and types of diagnostic activities until the final diagnostic treatment decision is made in all subjects
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).
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.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Sint Maartenskliniek
Collaborator
