Evaluating the AtMoves Knee System for diagnosing knee prosthesis loosening
Adequately Diagnosing Total Knee Arthroplasty Loosening: A Randomized Controlled Trial Evaluating the AtMoves Knee System in a Routine Clinical Setting
This study is testing if the AtMoves Knee System can help doctors better diagnose knee prosthesis loosening in patients who have had knee replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 7 sites (Nijmegen, Gelderland and 6 other locations) |
| Trial ID | NCT06839807 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of the AtMoves Knee System in diagnosing aseptic loosening in patients who have undergone total knee arthroplasty. Participants will be divided into two groups: one will receive additional CT scans using the AtMoves system, while the other will not. The primary outcome measure is the percentage of failed outcomes, defined as a decrease in the Knee injury and Osteoarthritis Outcome Score (KOOS-PS) at 12 months. Both groups will complete questionnaires during a one-year follow-up to evaluate their outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone total knee arthroplasty and are suspected of having aseptic loosening.
Not a fit: Patients with clear alternative diagnoses for their knee complaints, such as septic loosening or recent surgical interventions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diagnostic accuracy for patients with knee prosthesis issues, leading to better treatment decisions.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for diagnosing joint issues, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nijmegen, Gelderland and 6 other locations
- St. Maartenskliniek — Nijmegen, Gelderland, Netherlands (Not_yet_recruiting)
- Zuyderland Ziekenhuis — Heerlen, Limburg, Netherlands (Not_yet_recruiting)
- Amphia ziekenhuis — Breda, North Brabant, Netherlands (Not_yet_recruiting)
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
- Ocon — Hengelo, Overijsel, Netherlands (Not_yet_recruiting)
- NoordWest Ziekenhuisgroep — Alkmaar, Netherlands (Not_yet_recruiting)
- Elisabeth-TweeSteden Ziekenhuis — Tilburg, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Milo J.K. Mokkenstorm, MD
- Email: digitalknee@amsterdamumc.nl
- Phone: +31205662172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.