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

Last updated: February 17, 2025
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

AtMoves Knee System

Clinical Study ID

NCT06839807
DIGITAL-KNEE - 2024.0590
  • Ages > 18
  • All Genders

Study 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

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 orthopaedicsurgeon

  • 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 thediagnosis and proposal for treatment.

  • Subjects must be capable of giving informed consent and must be willing to undergoexamination with the AtMoves Knee System.

Exclusion

Exclusion Criteria:

  • A clear other cause for complaints other than aseptic loosening (e.g. septicloosening, neuropathic pain, non-consolidated peri-prosthetic fracture of the bonearound the TKA)

  • Surgical interventions of the index knee in the year prior to the start of thecomplaints associated with TKA loosening.

  • Posttraumatic or congenital deformation of the leg for which the loading device doesnot fit.

  • Pregnancy or suspected pregnancy.

  • Unable or unwilling to understand or sign the informed consent for this study and toundergo examination with the AtMoves Knee System.

Study Design

Total Participants: 124
Treatment Group(s): 1
Primary Treatment: AtMoves Knee System
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • St. Maartenskliniek

    Nijmegen, Gelderland 6574 NA
    Netherlands

    Site Not Available

  • Zuyderland Ziekenhuis

    Heerlen, Limburg 6419 PC
    Netherlands

    Site Not Available

  • Amphia ziekenhuis

    Breda, Noord-Brabant 4818CK
    Netherlands

    Site Not Available

  • Amsterdam UMC

    Amsterdam, Noord-Holland 1105AZ
    Netherlands

    Active - Recruiting

  • OCON

    Hengelo, Overijsel 7555 DL
    Netherlands

    Site Not Available

  • NoordWest Ziekenhuisgroep

    Alkmaar,
    Netherlands

    Site Not Available

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, 5022 GC
    Netherlands

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.