Evaluating the AtMoves Knee System for diagnosing knee prosthesis loosening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amsterdam UMC
  Amsterdam, North Holland, Netherlands Recruiting
• 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
• Ocon
  Hengelo, Overijsel, Netherlands Not yet recruiting
• NoordWest Ziekenhuisgroep
  Alkmaar, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Milo J.K. Mokkenstorm, MD
• Email: digitalknee@amsterdamumc.nl
• Phone: +31205662172

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.