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NCT Number: NCT06839807

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

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.

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Key information

Conditions

Aseptic Loosening Aseptic Loosening of Orthopaedic Hardware Aseptic Loosening of Prosthetic Joint Knee Arthroplasty, Total Total Knee Arthroplasty (Replacement)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Maartenskliniek, Nijmegen, Gelderland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AtMoves Knee System

Device

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 outcomes

  1. Failed Outcome

    Time frame: 12 months

    The primary outcome measure is the status of the outcome of the treatment as "failed outcome" at 12 months as determined by a change in KOOS-PS (Knee Injury and Osteoarthritis Outcome Score-Physical function Short form) that is less than the minimal clinically important difference (MCID) compared to baseline KOOS-PS (MCID is set to 15). The KOOS-PS gives a score from 0-100 with higher scores reflecting better physical function.

Secondary outcomes

  1. Revision surgery

    Time frame: 12 months

    The number of participants between the two arms that undergo revision surgery in the 12 months follow up period despite the initial decision (based on the diagnostic pathway) to not perform revision surgery.

  2. Number of Diagnostic activities

    Time frame: until the final diagnostic decision (up to six months)

    The number and types of diagnostic activities until the final diagnostic treatment decision is made in all subjects

  3. Cost of diagnostic activities

    Time frame: Upon the final diagnostic decision (up to six months).

    The cost of diagnostic activities until the final diagnostic treatment decision is made in all subjects. For cost-effectiveness evaluation. This will be measured using a version of the iMTA Medical Consumption Questionnaire (iMCQ).

  4. Medical consumption after diagnosis

    Time frame: 1 Year

    Medical consumption costs after final diagnosis and treatment until the end of follow-up (1 year). Measured using the iMTA Medical Consumption Questionnaire at 1 year follow-up.

  5. Societal productivity loss after diagnosis

    Time frame: 1 Year

    Societal productivity loss after final diagnosis and treatment until the end of follow-up (1 year). Measured using the iMTA Productivity Cost Questionnaire at 1 year follow-up.

  6. Subject satisfaction intervention group

    Time frame: Day of CT-scan using the AtMoves Knee system (day 0)

    Satisfaction of undergoing the AtMoves Knee System, measured in trial subjects randomized in the intervention arm. Measured by a short questionnaire including pain during- and after the scan (10 point numeric rating scale), subjective satisfaction of the scan (10 point numeric rating scale), and open field option for any comments on satisfaction on the day of the scan.

Study contacts

Contact information is provided by the study sponsor or research team.

Milo J.K. Mokkenstorm, MD

CONTACT

[email protected]

+31205662172

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Sint Maartenskliniek

Registry information

Official study title

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

Acronym: DigitalKnee

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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