Actively Recruiting
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-02-21
124
Participants Needed
7
Research Sites
13 weeks
Total Duration
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
S
Sint Maartenskliniek
Collaborating Sponsor
Researchers are evaluating the AtMoves Knee System to improve the diagnosis of aseptic loosening in patients who have received a total knee replacement. The main goal is to find out if using this specialized device during a CT scan can reduce the number of failed outcomes, defined by patient-reported knee function scores not showing meaningful improvement at 12 months. The study compares two groups to see if the AtMoves Knee System helps in clinical diagnosis and treatment decisions. Participants are randomly assigned to one of two groups. The intervention group undergoes a CT scan using the AtMoves Knee System, which applies specific forces to detect movement of the knee prosthesis component. Both groups continue with diagnostic and treatment plans determined by their orthopedic surgeons, with the control group not receiving the specialized CT scan. This allows researchers to assess the added value of the AtMoves system in routine clinical care. During the one-year follow-up period, participants complete questionnaires about their knee function. Researchers will track the percentage of failed outcomes, revision surgeries, diagnostic activities, related costs, medical use after diagnosis, societal productivity loss, and participant satisfaction with the AtMoves procedure. The study aims to provide a comprehensive evaluation of this diagnostic tool's impact on patient outcomes and healthcare use.
CONDITIONS
DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months until the final diagnostic decision
Participants undergo diagnostic assessments to determine the presence of total knee arthroplasty loosening. Those in the intervention group have a CT-scan using the AtMoves Knee System in addition to usual diagnostic care, while the control group undergoes usual diagnostic care without the CT-scan.
Visits depend on diagnostic activities determined by the treating orthopedic surgeon
Duration - 12 months
Participants are observed for outcomes such as revision surgery, medical consumption, and productivity loss after diagnosis over a 12-month period.
Follow-up visits as scheduled for monitoring outcomes
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
M
Milo J.K. Mokkenstorm, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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George S Buijs, Arthur J Kievit, Maaike A Ter Wee...
https://pubmed.ncbi.nlm.nih.gov/38819937