NCT06839807 DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting
| NCT ID | NCT06839807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Aseptic Loosening |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2025-02 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2025-02 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06839807 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aseptic Loosening. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839807 currently recruiting?
Yes, NCT06839807 is actively recruiting participants. Contact the research team at digitalknee@amsterdamumc.nl for enrollment information.
Where is the NCT06839807 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Heerlen, Netherlands, Breda, Netherlands, Amsterdam, Netherlands and 3 additional locations.
Who is sponsoring the NCT06839807 clinical trial?
NCT06839807 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 124 participants.