Adjuvant steroid to percutaneous needle fasciotomy for Dupuytren's contracture. An RCT study protocol.
Laura Houstrup Matthiesen, Simon Toftegaard Skov, Jeppe Lange
https://pubmed.ncbi.nlm.nih.gov/39749555Actively Recruiting
Phase 4
Age: 45Years - 99Years
All Genders
ID05440240
Percutaneous Needle Fasciotomy With or Without Corticosteroid Injection for Dupuytren's Contracture Affecting Metacarpophalangeal Joints: A Randomized Controlled Trial
Led by Regionshospitalet Silkeborg · Updated on 2023-05-17
400
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of percutaneous needle fasciotomy with or without corticosteroid injection for treating Dupuytren's contracture affecting the metacarpophalangeal (MCP) joints. This randomized controlled trial aims to compare these two treatment options in patients aged 45 to 99 years with this joint condition. The study is led by Regionshospitalet Silkeborg and is designed as a Phase 4 clinical trial with double masking. The study includes two treatment groups: one group will receive percutaneous needle fasciotomy combined with corticosteroid injection (Depo-Medrol), and the other group will receive the same fasciotomy combined with a saline injection as a placebo comparator. The fasciotomy procedure follows the Lermusiaux and Debeyre technique. Participants must have sufficient correction of the MCP joint during treatment, with less than 20 degrees passive extension deficit. Participants will be monitored for outcomes including the recurrence rate of contracture after two years. Assessments will focus on the correction of joint contracture, with follow-up visits to measure the effectiveness and safety of the treatments. The trial will also evaluate secondary outcomes related to joint function and patient well-being over the study period ending in March 2030.
CONDITIONS
Brief Title
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
Who Can Participate
Age: 45Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Dupuytren contracture of at least 20 degrees passive extension deficit in the metacarpophalangeal joint measured with a goniometer
- Contracture affecting fingers II to V
- Presence of a well-defined or palpable cord
- Sufficient correction of the metacarpophalangeal joint during treatment with less than 20 degrees passive extension deficit
You will not qualify if you...
- Legally incapacitated individuals
- Previous participation in the study with another finger ray
- Isolated contracture of proximal interphalangeal or distal interphalangeal joints with less than 20 degrees passive extension deficit in the metacarpophalangeal joint
- Previous hand surgery on the affected finger
- Known allergy to the study medication
- Current anticoagulant therapy (except acetylsalicylic acid)
- Pregnant or breastfeeding individuals
- Insulin-dependent diabetes mellitus
- Ongoing systemic or local infection at the procedure site
- Rheumatoid arthritis
- Amyloidosis or mucopolysaccharidosis
- Inability to communicate, cooperate, or participate in follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session
Participants undergo percutaneous needle fasciotomy with either corticosteroid injection or saline injection to treat Dupuytren's contracture.
1 treatment visit (in-person)
Follow-up
Duration - Up to 2 years
Participants are monitored for recurrence and outcomes after treatment.
Periodic visits during follow-up as scheduled
Trial Site Locations
Total: 1 location
1
Silkeborg Regional Hospital
Silkeborg, Denmark, 8600
Actively Recruiting
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Research Team
L
Laura H Matthiesen, MS, PhD-student
J
Jeppe Lange, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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