DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting
Recruiting
N/A
Interventional Study
Aseptic Loosening
Aseptic Loosening of Prosthetic Joint
Aseptic Loosening of Orthopaedic Hardware
Knee Arthroplasty, Total
Total Knee Arthroplasty (Replacement)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 124 (estimated)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Other
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About This Trial
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 Ou…
Trial Locations
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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, phys…
Contacts