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

Study Locations

  • Denmark
      • Silkeborg, Denmark, 8600
        • Recruiting
        • Silkeborg Regional Hospital
        • Contact:
        • 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
Procedure: Percutaneous needle fasciotomy
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
Drug: Corticosteroid injection
Depo-Medrol
Placebo Comparator: Saline injection
Percutaneous needle fasciotomy with saline injection
Procedure: Percutaneous needle fasciotomy
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
Other: Saline injection
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

Regionshospitalet Silkeborg

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

Keywords

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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