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

Adequately Diagnosing Total Knee Arthroplasty Loosening: a Randomized Controlled Trial 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.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty, Total; Aseptic Loosening; Aseptic Loosening of Prosthetic Joint; Aseptic Loosening of Orthopaedic Hardware; Total Knee Arthroplasty (replacement)
• Intervention / Treatment: Device: AtMoves Knee System

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Milo J.K. Mokkenstorm, MD; Phone Number: +31205662172; Email: digitalknee@amsterdamumc.nl

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Not yet recruiting
    • Noordwest Ziekenhuisgroep
    • Contact: George Buijs, MD; Phone Number: +3172 548 4444; Email: g.buijs@nwz.nl
  • Tilburg, Netherlands, 5022 GC
    • Not yet recruiting
    • Elisabeth-TweeSteden Ziekenhuis
    • Contact: Lennard van den Boom; Phone Number: +3113 221 0000; Email: info@etz.nl
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6574 NA
      • Not yet recruiting
      • St. Maartenskliniek
      • Contact: Petra Heesterbeek; Phone Number: +3124 365 9911; Email: p.heesterbeek@maartenskliniek.nl
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419 PC
      • Not yet recruiting
      • Zuyderland Ziekenhuis
      • Contact: Phone Number: +3188 459 7777; Email: info@zuyderland.nl
  • Noord-Brabant
    • Breda, Noord-Brabant, Netherlands, 4818CK
      • Not yet recruiting
      • Amphia Ziekenhuis
      • Contact: I Koenraadt-Van Oost; Phone Number: +3176 595 5000; Email: ivanoost@amphia.nl
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Recruiting
      • Amsterdam UMC
      • Contact: Milo J.K. Mokkenstorm, MD; Phone Number: +3120-5662172; Email: digitalknee@amsterdamumc.nl
      • Contact: Leendert Blankevoort, PhD; Phone Number: +31 20 56 66980; Email: L.Blankevoort@amsterdamumc.nl
      • Contact: Leendert Blankevoort, PhD
      • Contact: Milo J.K. Mokkenstorm, MD
      • Contact: Chiel Klein, Bsc
      • Contact: Arthur Kievit, MD
      • Contact: Matthias Schafroth, MD, PhD
      • Contact: Geert Streekstra, PhD
      • Contact: Iwan Dobbe, PhD
      • Contact: George S Buijs, MD
  • Overijsel
    • Hengelo, Overijsel, Netherlands, 7555 DL
      • Not yet recruiting
      • OCON
      • Contact: Max Havinga; Phone Number: +3188 708 3370; Email: f.wagenaar@ocon.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: AtMoves Knee System group; The intervention group will undergo a CT-scan using the AtMoves Knee System. They are allowed to undergo the diagnostic pathway determined by their treating orthopedic surgeon.	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.
No Intervention: Control: usual care/diagnostics; The control group is not allowed to undergo a CT-scan using the AtMoves Knee System. They will undergo the diagnostic pathway determined by their treating orthopedic surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failed Outcome	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision surgery	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.	12 months
Number of Diagnostic activities	The number and types of diagnostic activities until the final diagnostic treatment decision is made in all subjects	until the final diagnostic decision (up to six months)
Cost of diagnostic activities	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).	Upon the final diagnostic decision (up to six months).
Medical consumption after diagnosis	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.	1 Year
Societal productivity loss after diagnosis	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.	1 Year
Subject satisfaction intervention group	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.	Day of CT-scan using the AtMoves Knee system (day 0)

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Sint Maartenskliniek

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Knee arthroplasty; Aseptic loosening of total knee prosthesis; Aseptic loosening; Aseptic loosening of prosthetic joint
• Other Study ID Numbers: DIGITAL-KNEE - 2024.0590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be made pubicly available but can be obtained upon request at the study's sponsor. When a valid reason for the re-use of study data is provided, a Data Sharing Agreement can be set up.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No