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Recruiting NCT06839807

DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting

No phase Interventional Aseptic Loosening Aseptic Loosening of Prosthetic Joint Aseptic Loosening of Orthopaedic Hardware Knee Arthroplasty, Total

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AtMoves Knee System.
Who it may be relevant to
Registry conditions: Aseptic Loosening, Aseptic Loosening of Prosthetic Joint, Aseptic Loosening of Orthopaedic Hardware, Knee Arthroplasty, Total. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Adequately Diagnosing Total Knee Arthroplasty Loosening: A Randomized Controlled Trial Evaluating the AtMoves Knee System in a Routine Clinical Setting

Overview

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.

Interventions

  • Device AtMoves Knee System
    The AtMoves Knee Stystem is a loading device that is able to exert force in varus and valgus. when these forces are applied during a CT-scan micromotions of the tibial component of the total knee prosthesis can be detected.

Primary outcome measures

  • Failed Outcome [Time frame: 12 months]
Secondary outcome measures (6)
  • Revision surgery [Time frame: 12 months]
  • Number of Diagnostic activities [Time frame: until the final diagnostic decision (up to six months)]
  • Cost of diagnostic activities [Time frame: Upon the final diagnostic decision (up to six months).]
  • Medical consumption after diagnosis [Time frame: 1 Year]
  • Societal productivity loss after diagnosis [Time frame: 1 Year]
  • Subject satisfaction intervention group [Time frame: Day of CT-scan using the AtMoves Knee system (day 0)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 7 centers
  • St. Maartenskliniek — Nijmegen
  • Zuyderland Ziekenhuis — Heerlen
  • Amphia ziekenhuis — Breda
  • Amsterdam UMC — Amsterdam
  • OCON — Hengelo
  • NoordWest Ziekenhuisgroep — Alkmaar
  • Elisabeth-TweeSteden Ziekenhuis — Tilburg

Publications

  • Buijs GS, Kievit AJ, Ter Wee MA, Magg C, Dobbe JGG, Streekstra GJ, Schafroth MU, Blankevoort L. Non-invasive quantitative assessment of induced component displacement can safely and accurately diagnose tibial component loosening in patients: A prospective diagnostic study. Knee Surg Sports Traumatol Arthrosc. 2025 Jan;33(1):274-285. doi: 10.1002/ksa.12299. Epub 2024 May 31. PMID 38819937

Identifiers

NCT: NCT06839807 · DIGITAL-KNEE - 2024.0590

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗