Dupuytren's DiseaseGoniometryNCT06263699
Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease
An observational study of Dupuytren's Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease
- What is being tested?
- ROM measurement of the MCP and PIP joints in digits 4 and 5
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jan 2024to 3 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with diagnosed Dupuytren's disease
Who may be able to join
- Older than 18 years of age
- Current AED in digit 4 or 5, in the MCP or PIP joint
Who cannot join
- Abnormalities to the fingers other than Dupuytren's disease which make goniometry impossible (e.g. amputation, arthrodesis of finger joints, deformations due to rheumatoid arthritis etc.)
- Patient's unable to give a written participating consent.
- Younger than 18 years of age.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Comparing the Accuracy of Clinical Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease
Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer can be time consuming. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer.
Read the detailed description
Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer to measure the extension deficit of both fingers, for both the proximal interphalangeal (PIP) and metacarpophalangeal (MCP) joint can be a time consuming process. A lot of clinicians have limited time per patient, which leads to partially or completely missing data due to not performing the measurements. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer. Establishing the difference between both methods is essential to monitor change, which makes a statistical comparison of accuracy of both methods very valuable for patients with Dupuytren's disease. Furthermore, a lot of clinicians have collected and stored standardised pictures of their patient's hands over the years. Therefore this study could solidify the available data through these images, which provide valuable information for future follow up. Furthermore, proper patient education could provide the clinician with standardised images taken by the patient himself, leading to improved follow up, if images and clinical measurement prove to be equally accurate.
- Conditions
- Dupuytren's Disease
- Being tested
- ROM measurement of the MCP and PIP joints in digits 4 and 5
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROM measurement of the MCP and PIP joints in digits 4 and 5Procedure or surgery
Also called Standardised picture of the hand
standardised picture of the hand in maximal active extension, with the back of the hand positioned on the table's surface
| Study group | Role | What they receive |
|---|---|---|
| Patients with diagnosed Dupuytren's disease | Range of motion measurement of the MCP and PIP joints in digits 4 and 5 Receives: Procedure: ROM measurement of the MCP and PIP joints in digits 4 and 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Extension Deficits (AED)
AED in the MCP and PIP joints of digit 4 and 5 are measured by using a goniometer
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start29 Jan 2024
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilse Degreef, Prof. Dr, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263699
- Sponsor's protocol ID
- S68225
- Acronym
- Goniometry
- Status last verified
- Jul 2025
- First submitted
- 8 Feb 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Accuracy of Clinical Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease
- ClinicalTrials.gov ID
- NCT06263699
- Acronym / sponsor ID
- Goniometry / S68225
- Conditions
- Dupuytren's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 16 Feb 2024 (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.
Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer can be time consuming. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer.
Detailed description
Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer to measure the extension deficit of both fingers, for both the proximal interphalangeal (PIP) and metacarpophalangeal (MCP) joint can be a time consuming process. A lot of clinicians have limited time per patient, which leads to partially or completely missing data due to not performing the measurements. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer. Establishing the difference between both methods is essential to monitor change, which makes a statistical comparison of accuracy of both methods very valuable for patients with Dupuytren's disease. Furthermore, a lot of clinicians have collected and stored standardised pictures of their patient's hands over the years. Therefore this study could solidify the available data through these images, which provide valuable information for future follow up. Furthermore, proper patient education could provide the clinician with standardised images taken by the patient himself, leading to improved follow up, if images and clinical measurement prove to be equally accurate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diagnosed Dupuytren's disease | – | Procedure: ROM measurement of the MCP and PIP joints in digits 4 and 5Range of motion measurement of the MCP and PIP joints in digits 4 and 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed Dupuytren's disease
Key inclusion criteria (2 listed)
- Older than 18 years of age
- Current AED in digit 4 or 5, in the MCP or PIP joint
Key exclusion criteria (3 listed)
- Abnormalities to the fingers other than Dupuytren's disease which make goniometry impossible (e.g. amputation, arthrodesis of finger joints, deformations due to rheumatoid arthritis etc.)
- Patient's unable to give a written participating consent.
- Younger than 18 years of age.
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 |
|---|---|---|
| ROM measurement of the MCP and PIP joints in digits 4 and 5Also: Standardised picture of the handstandardised picture of the hand in maximal active extension, with the back of the hand positioned on the table's surface | Procedure or surgery | Patients with diagnosed Dupuytren's disease |
Primary outcome
Active Extension Deficits (AED)
Time frame: Baseline
AED in the MCP and PIP joints of digit 4 and 5 are measured by using a goniometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Dupuytren's Disease
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DEPART Study at Yale
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Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
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Skin Involvement in Dupuytren Surgical Treatment Outcome
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Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
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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. This study is not recruiting at the moment.
Ilse Degreef, Prof. Dr principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Extension Deficits (AED) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2025.