- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05440240
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
May 15, 2023 updated by: Laura Houstrup Matthiesen, Regionshospitalet Silkeborg
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laura H Matthiesen, MS, PhD-student
- Phone Number: 004561281917
- Email: lather@rm.dk
Study Contact Backup
- Name: Jeppe Lange, MD, PhD
- Email: jepplang@rm.dk
Study Locations
-
-
-
Silkeborg, Denmark, 8600
- Recruiting
- Silkeborg Regional Hospital
-
Contact:
- Jeppe Lange, MD, PhD
- Email: jepplang@rm.dk
-
Contact:
- Laura H Matthiesen, PhD Student
- Phone Number: 004561281917
- Email: lather@rm.dk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as <20° passive extension deficit (PED), is a prerequisite for inclusion.
Inclusion Criteria:
- Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer
- DC of either II-V finger
- Well-defined/palpable cord
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Corticosteroid injection
Percutaneous needle fasciotomy with corticosteroid injection
|
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
Depo-Medrol
|
Placebo Comparator: Saline injection
Percutaneous needle fasciotomy with saline injection
|
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
Isotonic saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence rate
Time Frame: 2 years
|
Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jeppe Lange, MD, PhD, Horsens Regional Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2023
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
March 1, 2030
Study Registration Dates
First Submitted
June 27, 2022
First Submitted That Met QC Criteria
June 27, 2022
First Posted (Actual)
June 30, 2022
Study Record Updates
Last Update Posted (Actual)
May 17, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-985
- 2022-501021-20-00 (Other Identifier: EU CT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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