Clinical trial NCT06839807: DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting
Official title: Adequately Diagnosing Total Knee Arthroplasty Loosening: A Randomized Controlled Trial Evaluating the AtMoves Knee System in a Routine Clinical Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aseptic Loosening
Aseptic Loosening of Prosthetic Joint
Aseptic Loosening of Orthopaedic Hardware
Knee Arthroplasty, Total
Total Knee Arthroplasty (Replacement)
Keywords: Aseptic loosening of total knee prosthesis
Aseptic loosening
Total knee arthroplasty
Aseptic loosening of prosthetic joint
Knee arthroplasty
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Sint Maartenskliniek
First posted: 2025-02-21
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT)
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Failed Outcome
timeFrame: 12 months
Secondary outcomes:
measure: Revision surgery
timeFrame: 12 months
measure: Number of Diagnostic activities
timeFrame: until the final diagnostic decision (up to six months)
measure: Cost of diagnostic activities
timeFrame: Upon the final diagnostic decision (up to six months).
measure: Medical consumption after diagnosis
timeFrame: 1 Year
measure: Societal productivity loss after diagnosis
timeFrame: 1 Year
measure: Subject satisfaction intervention group
timeFrame: Day of CT-scan using the AtMoves Knee system (day 0)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: St. Maartenskliniek
state: Gelderland
city: Heerlen
country: Netherlands
facility: Zuyderland Ziekenhuis
state: Limburg
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Hengelo
country: Netherlands
facility: OCON
state: Overijsel
city: Alkmaar
country: Netherlands
facility: NoordWest Ziekenhuisgroep
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
Study officials:
References:
citation: 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.