looseness Loosening
Conditions
Interventions
The subject in the intervention group receives the AtMoves Knee System
evaluation, which includes both diagnostic reprocessing according to the
standard protocol along with two CT scans of the affec
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, subjects must meet all of the following criteria: - Subjects must have undergone unilateral or bilateral total knee arthroplasty. - Total knee arthroplasty surgery must have been performed at least one year ago. - Subjects must be suspected of aseptic loosening of the knee prosthesis. - The treating orthopedist must deem additional examination (other than standard diagnostics) necessary to reach a sound diagnosis. - Subjects must be able to give informed consent and be willing to undergo research using the AtMoves Knee System.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Subjects with another cause for revision surgery other than aseptic loosening (e.g. septic loosening) - Subjects with surgical interventions of the index knee in the year prior to the start of the complaints associated with TKA loosening. - Subjects with presence of systemic musculoskeletal diseases. - Subjects with a non-consolidated peri-prosthetic fracture of the bone around the TKA. - Subjects with pregnancy or suspected pregnancy. - Subject who are unable or unwilling to sign the informed consent for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the status of the surgical procedure as a *failed outcome* as determined according to the delta KOOS-PS score | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are: (1) 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, (2) the number and types of diagnostic measures used between the two groups, along with the potential cost reduction by avoiding unnecessary revision surgery, and (3) societal productivity loss and medical consumption after the final diagnosis and treatment decision and, (4) subject and physician satisfaction with the diagnostic process between the two groups. | — |
Countries
Netherlands
Contacts
Public ContactM Mokkenstorm
Amsterdam UMC
Outcome results
None listed