Aseptic LooseningDigitalKneeNCT06839807
DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting
A study testing AtMoves Knee System in people with Aseptic Loosening and Aseptic Loosening of Prosthetic Joint, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 7 sites in Netherlands.
Trial 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"… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aseptic Loosening, Aseptic Loosening of Prosthetic Joint, Aseptic Loosening of Orthopaedic Hardware
- What is being tested?
- AtMoves Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 7 sitesNetherlands
- Study dates
- Feb 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Not yet recruiting
NoordWest Ziekenhuisgroep
Alkmaar
George Buijs, MD, +3172 548 4444, g.buijs@nwz.nl
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105AZ
Milo J.K. Mokkenstorm, MD, +3120-5662172, digitalknee@amsterdamumc.nl
Leendert Blankevoort, PhD, +31 20 56 66980, L.Blankevoort@amsterdamumc.nl
- Not yet recruiting
Amphia ziekenhuis
Breda, North Brabant, 4818CK
I Koenraadt-Van Oost, +3176 595 5000, ivanoost@amphia.nl
- Not yet recruiting
Zuyderland Ziekenhuis
Heerlen, Limburg, 6419 PC
+3188 459 7777, info@zuyderland.nl
- Not yet recruiting
OCON
Hengelo, Overijsel, 7555 DL
Max Havinga, +3188 708 3370, f.wagenaar@ocon.nl
- Not yet recruiting
St. Maartenskliniek
Nijmegen, Gelderland, 6574 NA
Petra Heesterbeek, +3124 365 9911, p.heesterbeek@maartenskliniek.nl
- Not yet recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC
Lennard van den Boom, +3113 221 0000, info@etz.nl
About this study
Official title: 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.
Read more
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
- Aseptic Loosening, Aseptic Loosening of Prosthetic Joint, Aseptic Loosening of Orthopaedic Hardware, Knee Arthroplasty, Total, Total Knee Arthroplasty (Replacement)
- Being tested
- AtMoves Knee System
- Keywords
- Aseptic loosening of total knee prosthesis, Aseptic loosening, Total knee arthroplasty, Aseptic loosening of prosthetic joint, Knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
Number of Diagnostic activities
The number and types of diagnostic activities until the final diagnostic treatment decision is made in all subjects
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day of CT-scan using the AtMoves Knee system (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aseptic LooseningStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT)
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sint Maartenskliniek
- Responsible party
- Principal investigator, Leendert Blankevoort, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839807
- Sponsor's protocol ID
- DIGITAL-KNEE - 2024.0590
- Acronym
- DigitalKnee
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 38819937
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequately Diagnosing Total Knee Arthroplasty Loosening: A Randomized Controlled Trial Evaluating the AtMoves Knee System in a Routine Clinical Setting
- ClinicalTrials.gov ID
- NCT06839807
- Acronym / sponsor ID
- DigitalKnee / DIGITAL-KNEE - 2024.0590
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Sint Maartenskliniek
- Study start
- Feb 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Intervention: AtMoves Knee System group | Experimental | Device: AtMoves Knee SystemThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtMoves Knee SystemThe 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. | Device | Intervention: AtMoves Knee System group |
Primary outcome
Failed Outcome
Time frame: 12 months
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.
6 secondary outcomes
Revision surgery
Time frame: 12 months
Number of Diagnostic activities
Time frame: until the final diagnostic decision (up to six months)
Cost of diagnostic activities
Time frame: Upon the final diagnostic decision (up to six months).
Medical consumption after diagnosis
Time frame: 1 Year
Societal productivity loss after diagnosis
Time frame: 1 Year
Subject satisfaction intervention group
Time frame: Day of CT-scan using the AtMoves Knee system (day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 38819937Buijs 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AtMoves Knee System in people with Aseptic Loosening and Aseptic Loosening of Prosthetic Joint, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milo J.K. Mokkenstorm, MD (+31205662172, digitalknee@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failed Outcome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06839807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.