NCT06839807

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2025

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Feb 2025Jun 2026

First Submitted

Initial submission to the registry

January 7, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

January 7, 2025

Last Update Submit

February 17, 2025

Conditions

Aseptic LooseningAseptic Loosening of Prosthetic JointAseptic Loosening of Orthopaedic HardwareKnee Arthroplasty, TotalTotal Knee Arthroplasty (Replacement)

Keywords

Aseptic loosening of total knee prosthesisAseptic looseningTotal knee arthroplastyAseptic loosening of prosthetic jointKnee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Revision surgery

    12 months

  • Number of Diagnostic activities

    until the final diagnostic decision (up to six months)

  • Cost of diagnostic activities

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

  • Medical consumption after diagnosis

    1 Year

  • Societal productivity loss after diagnosis

    1 Year

  • +1 more secondary outcomes

Study Arms (2)

Intervention: AtMoves Knee System group

EXPERIMENTAL

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

Control: usual care/diagnostics

NO INTERVENTION

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.

Interventions

AtMoves Knee SystemDEVICE

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.

Intervention: AtMoves Knee System group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

St. Maartenskliniek

Nijmegen, Gelderland, 6574 NA, Netherlands

NOT YET RECRUITING

Zuyderland Ziekenhuis

Heerlen, Limburg, 6419 PC, Netherlands

NOT YET RECRUITING

Amphia ziekenhuis

Breda, North Brabant, 4818CK, Netherlands

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

OCON

Hengelo, Overijsel, 7555 DL, Netherlands

NOT YET RECRUITING

NoordWest Ziekenhuisgroep

Alkmaar, Netherlands

NOT YET RECRUITING

Elisabeth-TweeSteden Ziekenhuis

Tilburg, 5022 GC, Netherlands

NOT YET RECRUITING

Related Publications (1)

  • 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: 38819937BACKGROUND

Central Study Contacts

Milo J.K. Mokkenstorm, MD

CONTACT

+31205662172digitalknee@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized controlled trial (RCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 7, 2025

First Posted

February 21, 2025

Study Start

February 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

NL(7)