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RecruitingNCT05440240Updated May 17, 2023

Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture

A Phase 4 interventional study of Percutaneous needle fasciotomy and Corticosteroid injection in Dupuytren Contracture, Dupuytren's Disease and Contracture, sponsored by Regionshospitalet Silkeborg. Recruiting at 1 site in Denmark. Open to participants aged 45 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-05-17.

Sponsored by Regionshospitalet Silkeborg · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 10 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
45 Years to 99 Years
Sex
All
01

Study summary

Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.

02

Conditions studied

  • 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
03

In context

Dupuytren Contracture

78 studies on the registry are indexed under Dupuytren Contracture; 18 are open to participants now.

This study's planned enrollment of 400 is above the median of 72 across 57 interventional studies indexed under Dupuytren Contracture.

Browse Dupuytren Contracture studies →

Lead sponsor

Regionshospitalet Silkeborg is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as \<20° passive extension deficit (PED), is a prerequisite for inclusion.

Inclusion criteria

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    Corticosteroid injection

    Percutaneous needle fasciotomy with corticosteroid injection

    Procedure: Percutaneous needle fasciotomy · Drug: Corticosteroid injection

  • Placebo comparator
    Saline injection

    Percutaneous needle fasciotomy with saline injection

    Procedure: Percutaneous needle fasciotomy · Other: Saline injection

Interventions

  • ProcedurePercutaneous needle fasciotomy

    Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

  • DrugCorticosteroid injection

    Depo-Medrol

  • OtherSaline injection

    Isotonic saline

06

What researchers measure

Primary outcomes

  1. Recurrence rate

    Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05440240
Lead sponsor
Regionshospitalet Silkeborg
Responsible party
Laura Houstrup Matthiesen (Medical Student, PhD Student, Regionshospitalet Silkeborg) — Principal investigator
First posted
Jun 30, 2022
Start date
Jan 10, 2023
Primary completion
Dec 2025 (estimated)
Completion
Mar 2030 (estimated)
Last update
May 17, 2023

Study contacts

Laura H Matthiesen, MS, PhD-student
Contact
lather@rm.dk
004561281917
Jeppe Lange, MD, PhD
Contact
jepplang@rm.dk
Jeppe Lange, MD, PhD
study director · Horsens Regional Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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