Dupuytren ContracturePhase 4NCT05440240
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
A Phase 4 study testing Percutaneous needle fasciotomy, Corticosteroid injection and Saline injection in people with Dupuytren Contracture and Dupuytren's Disease, run by Regionshospitalet Silkeborg at 1 site in Denmark.
Trial summary
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 45 to 99 years
- Conditions the study is for
- Dupuytren Contracture, Dupuytren's Disease, Contracture
- What is being tested?
- Percutaneous needle fasciotomy, Corticosteroid injection and Saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jan 2023to Mar 2030
- Phase
- Phase 4
- 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 45 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer
- DC of either II-V finger
- Well-defined/palpable cord
Who cannot join
- Legally incapacitated
- Previous study inclusion with another finger ray
- Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture < 20° PED regardless of the deficit in the PIP or DIP joint
- Previous hand surgery of the affected finger for any reason
- Known allergy to the study medication
- Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion)
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- Pregnant or lactation
- Insulin dependent diabetes mellitus
- Ongoing systemic infection or local infection at the site of the procedure
- Rheumatoid arthritis
- Amyloidosis or mucopolysaccharidosis
- Unable to communicate, cooperate or participate in follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jeppe Lange, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Silkeborg Regional Hospital
Silkeborg, 8600
Laura H Matthiesen, PhD Student, 004561281917, lather@rm.dk
Jeppe Lange, MD, PhD, jepplang@rm.dk
About this study
Official title: Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.
- Conditions
- Dupuytren Contracture, Dupuytren's Disease, Contracture, Joint Diseases, Musculoskeletal Diseases, Fibroma
- Being tested
- Percutaneous needle fasciotomy, Corticosteroid injection, Saline injection
- Keywords
- Percutaneous needle fasciotomy, Corticosteroid, Randomized controlled trial
- Medical subject headings
- Dupuytren Contracture, Contracture, Joint Diseases, Musculoskeletal Diseases, Fibroma, Neoplasms, Fibrous Tissue, Neoplasms, Connective Tissue, Neoplasms, Connective and Soft Tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous needle fasciotomyProcedure or surgery
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
Corticosteroid injectionDrug
Depo-Medrol
Saline injectionOther
Isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid injection | Active comparator | Percutaneous needle fasciotomy with corticosteroid injection Receives: Procedure: Percutaneous needle fasciotomy; Drug: Corticosteroid injection |
| Saline injection | Placebo comparator | Percutaneous needle fasciotomy with saline injection Receives: Procedure: Percutaneous needle fasciotomy; Other: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start10 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionMar 2030 (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 Dupuytren ContractureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Silkeborg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Houstrup Matthiesen, Regionshospitalet Silkeborg
- Investigators
- Jeppe Lange, MD, PhD, Study director, Regionshospitalet Horsens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440240
- Sponsor's protocol ID
- 2022-985
- Other IDs
- 2022-501021-20-00
- Status last verified
- May 2023
- First submitted
- 27 Jun 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matthiesen LH, Skov ST, Lange J. Adjuvant steroid to percutaneous needle fasciotomy for Dupuytren's contracture. An RCT study protocol. Dan Med J. 2024 Nov 12;71(12):A05240324. doi: 10.61409/A05240324.
PubMed 39749555
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05440240
- Acronym / sponsor ID
- 2022-985
- Conditions
- Dupuytren Contracture, Dupuytren's Disease, Contracture, Joint Diseases, Musculoskeletal Diseases, Fibroma
- Keywords
- Percutaneous needle fasciotomy, Corticosteroid, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Regionshospitalet SilkeborgUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 30 Jun 2022 (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.
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid injection | Active comparator | Procedure: Percutaneous needle fasciotomy, Drug: Corticosteroid injectionPercutaneous needle fasciotomy with corticosteroid injection |
| Saline injection | Placebo comparator | Procedure: Percutaneous needle fasciotomy, Other: Saline injectionPercutaneous needle fasciotomy with saline injection |
Who may qualify
- Ages
- 45 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer
- DC of either II-V finger
- Well-defined/palpable cord
Key exclusion criteria (12 listed)
- Legally incapacitated
- Previous study inclusion with another finger ray
- Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture < 20° PED regardless of the deficit in the PIP or DIP joint
- Previous hand surgery of the affected finger for any reason
- Known allergy to the study medication
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 |
|---|---|---|
| Percutaneous needle fasciotomyPercutaneous needle fasciotomy ad modum Lermusiaux and Debeyre | Procedure or surgery | Corticosteroid injection, Saline injection |
| Corticosteroid injectionDepo-Medrol | Drug | Corticosteroid injection |
| Saline injectionIsotonic saline | Other | Saline injection |
Primary outcome
Recurrence rate
Time frame: 2 years
Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline
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 17 May 2023.
- Derived from this study: PubMed 39749555Matthiesen LH, Skov ST, Lange J. Adjuvant steroid to percutaneous needle fasciotomy for Dupuytren's contracture. An RCT study protocol. Dan Med J. 2024 Nov 12;71(12):A05240324. doi: 10.61409/A05240324.
- Individual participant dataSharing planned: No
Related trials for Dupuytren 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.
Jeppe Lange, MD, PhD contact
Jeppe Lange, MD, PhD study director
Regionshospitalet Horsens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous needle fasciotomy, Corticosteroid injection and Saline injection in people with Dupuytren Contracture and Dupuytren's Disease, run by Regionshospitalet Silkeborg at 1 site in Denmark.
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 3 inclusion and 12 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 17 May 2023. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Laura H Matthiesen, MS, PhD-student (004561281917, lather@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 2 years). 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 NCT05440240, 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 17 May 2023.