Aseptic Loosening, Aseptic Loosening of Orthopaedic Hardware, Aseptic Loosening of Prosthetic Joint, Knee Arthroplasty, Total, Total Knee Arthroplasty (Replacement)
Conditions
Keywords
Aseptic loosening of total knee prosthesis, Aseptic loosening, Total knee arthroplasty, Aseptic loosening of prosthetic joint, Knee arthroplasty
Brief 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.
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.
Sponsors
Sint Maartenskliniek
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized controlled trial (RCT)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * The surgeon wants additional examinations or additional imaging to arrive at the diagnosis and proposal for treatment. * Subjects must be capable of giving informed consent and must be willing to undergo examination with the AtMoves Knee System.
Exclusion criteria
* 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. * Unable or unwilling to understand or sign the informed consent for this study and to undergo examination with the AtMoves Knee System.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failed Outcome | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Diagnostic activities | until the final diagnostic decision (up to six months) | The number and types of diagnostic activities until the final diagnostic treatment decision is made in all subjects |
| Cost of diagnostic activities | Upon the final diagnostic decision (up to six months). | 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). |
| Revision surgery | 12 months | 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. |
| Societal productivity loss after diagnosis | 1 Year | 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. |
| Subject satisfaction intervention group | Day of CT-scan using the AtMoves Knee system (day 0) | 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. |
| Medical consumption after diagnosis | 1 Year | 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. |
Countries
Netherlands
Contacts
Primary ContactMilo J.K. Mokkenstorm, MD
Outcome results
None listed