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| Name | Class |
|---|---|
| Sint Maartenskliniek | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: AtMoves Knee System group | Experimental | The intervention group will undergo a CT-scan using the AtMoves Knee System. They are allowed to undergo the diagnostic pathway determined by their treating orthopedic surgeon. |
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| Control: usual care/diagnostics | No Intervention | The control group is not allowed to undergo a CT-scan using the AtMoves Knee System. They will undergo the diagnostic pathway determined by their treating orthopedic surgeon. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtMoves Knee System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Number of Diagnostic activities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Milo J.K. Mokkenstorm, MD | Contact | +31205662172 | digitalknee@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Maartenskliniek | Not yet recruiting | Nijmegen | Gelderland | 6574 NA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38819937 | Background | Buijs GS, Kievit AJ, Ter Wee MA, Magg C, Dobbe JGG, Streekstra GJ, Schafroth MU, Blankevoort L. Non-invasive quantitative assessment of induced component displacement can safely and accurately diagnose tibial component loosening in patients: A prospective diagnostic study. Knee Surg Sports Traumatol Arthrosc. 2025 Jan;33(1):274-285. doi: 10.1002/ksa.12299. Epub 2024 May 31. |
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IPD will not be made pubicly available but can be obtained upon request at the study's sponsor. When a valid reason for the re-use of study data is provided, a Data Sharing Agreement can be set up.
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Randomized controlled trial (RCT)
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The number and types of diagnostic activities until the final diagnostic treatment decision is made in all subjects |
| 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). | 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. | 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. | 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. | Day of CT-scan using the AtMoves Knee system (day 0) |
| Zuyderland Ziekenhuis | Not yet recruiting | Heerlen | Limburg | 6419 PC | Netherlands |
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| Amphia ziekenhuis | Not yet recruiting | Breda | North Brabant | 4818CK | Netherlands |
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| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
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| OCON | Not yet recruiting | Hengelo | Overijsel | 7555 DL | Netherlands |
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| NoordWest Ziekenhuisgroep | Not yet recruiting | Alkmaar | Netherlands |
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| Elisabeth-TweeSteden Ziekenhuis | Not yet recruiting | Tilburg | 5022 GC | Netherlands |
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