Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
Primary Purpose
Dupuytren Contracture, Dupuytren's Disease, Contracture
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Percutaneous needle fasciotomy
Corticosteroid injection
Saline injection
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytren Contracture focused on measuring Percutaneous needle fasciotomy, Corticosteroid, Randomized controlled trial
Eligibility Criteria
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
Sites / Locations
- Silkeborg Regional HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Corticosteroid injection
Saline injection
Arm Description
Percutaneous needle fasciotomy with corticosteroid injection
Percutaneous needle fasciotomy with saline injection
Outcomes
Primary Outcome Measures
Recurrence rate
Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT05440240
First Posted
June 27, 2022
Last Updated
May 15, 2023
Sponsor
Regionshospitalet Silkeborg
1. Study Identification
Unique Protocol Identification Number
NCT05440240
Brief Title
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
Official Title
Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
March 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionshospitalet Silkeborg
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren Contracture, Dupuytren's Disease, Contracture, Joint Diseases, Musculoskeletal Diseases, Fibroma, Neoplasm, Fibrous Tissue, Neoplasms, Connective Tissue, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type, Neoplasms, Connective Tissue Diseases
Keywords
Percutaneous needle fasciotomy, Corticosteroid, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Corticosteroid injection
Arm Type
Active Comparator
Arm Description
Percutaneous needle fasciotomy with corticosteroid injection
Arm Title
Saline injection
Arm Type
Placebo Comparator
Arm Description
Percutaneous needle fasciotomy with saline injection
Intervention Type
Procedure
Intervention Name(s)
Percutaneous needle fasciotomy
Intervention Description
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injection
Intervention Description
Depo-Medrol
Intervention Type
Other
Intervention Name(s)
Saline injection
Intervention Description
Isotonic saline
Primary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura H Matthiesen, MS, PhD-student
Phone
004561281917
Email
lather@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jeppe Lange, MD, PhD
Email
jepplang@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeppe Lange, MD, PhD
Organizational Affiliation
Horsens Regional Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Silkeborg Regional Hospital
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura H Matthiesen, PhD Student
Phone
004561281917
Email
lather@rm.dk
First Name & Middle Initial & Last Name & Degree
Jeppe Lange, MD, PhD
Email
jepplang@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
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