Actively Recruiting
DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-02-21
124
Participants Needed
7
Research Sites
69 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
S
Sint Maartenskliniek
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Have undergone unilateral or bilateral total knee arthroplasty surgery.
- Aseptic loosening is considered as a possible diagnosis by the treating orthopedic surgeon.
- The orthopedic surgeon is uncertain of the diagnosis after history, physical exam, and X-ray.
- The surgeon requests additional examinations or imaging to confirm diagnosis and treatment plan.
- Able to give informed consent and willing to undergo examination with the AtMoves Knee System.
You will not qualify if you...
- Clear other causes for symptoms besides aseptic loosening (e.g., septic loosening, neuropathic pain, non-healed peri-prosthetic fracture).
- Knee surgery on the affected knee within one year before symptom onset.
- Posttraumatic or congenital leg deformity that prevents fitting the loading device.
- Pregnant or suspected pregnancy.
- Unable or unwilling to understand or sign informed consent or to undergo AtMoves Knee System examination.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
St. Maartenskliniek
Nijmegen, Gelderland, Netherlands, 6574 NA
Not Yet Recruiting
2
Zuyderland Ziekenhuis
Heerlen, Limburg, Netherlands, 6419 PC
Not Yet Recruiting
3
Amphia ziekenhuis
Breda, North Brabant, Netherlands, 4818CK
Not Yet Recruiting
4
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
5
OCON
Hengelo, Overijsel, Netherlands, 7555 DL
Not Yet Recruiting
6
NoordWest Ziekenhuisgroep
Alkmaar, Netherlands
Not Yet Recruiting
7
Elisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands, 5022 GC
Not Yet Recruiting
Research Team
M
Milo J.K. Mokkenstorm, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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