NCT05440240

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
47mo left

Started Jan 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2023Mar 2030

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Expected
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

June 27, 2022

Last Update Submit

May 15, 2023

Conditions

Dupuytren ContractureDupuytren's DiseaseContractureJoint DiseasesMusculoskeletal DiseasesFibromaNeoplasm, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue Diseases

Keywords

Percutaneous needle fasciotomyCorticosteroidRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

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

    2 years

Study Arms (2)

Corticosteroid injection

ACTIVE COMPARATOR

Percutaneous needle fasciotomy with corticosteroid injection

Procedure: Percutaneous needle fasciotomyDrug: Corticosteroid injection

Saline injection

PLACEBO COMPARATOR

Percutaneous needle fasciotomy with saline injection

Procedure: Percutaneous needle fasciotomyOther: Saline injection

Interventions

Percutaneous needle fasciotomyPROCEDURE

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Corticosteroid injectionSaline injection
Corticosteroid injectionDRUG

Depo-Medrol

Corticosteroid injection
Saline injectionOTHER

Isotonic saline

Saline injection

Eligibility Criteria

Age45 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer
  • DC of either II-V finger
  • Well-defined/palpable cord

You may not qualify if:

  • Legally incapacitated
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

RECRUITING

Related Publications (1)

  • Matthiesen LH, Skov ST, Lange J. Adjuvant steroid to percutaneous needle fasciotomy for Dupuytren's contracture. An RCT study protocol. Dan Med J. 2024 Nov 12;71(12):A05240324. doi: 10.61409/A05240324.

    PMID: 39749555DERIVED

MeSH Terms

Conditions

Dupuytren ContractureContractureJoint DiseasesMusculoskeletal DiseasesFibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue Diseases

Interventions

Adrenal Cortex HormonesSodium Chloride

Condition Hierarchy (Ancestors)

Muscular DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jeppe Lange, MD, PhD

    Regionshospitalet Horsens

    STUDY DIRECTOR

Central Study Contacts

Laura H Matthiesen, MS, PhD-student

CONTACT

004561281917lather@rm.dk

Jeppe Lange, MD, PhD

CONTACT

jepplang@rm.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Student, PhD Student

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

January 10, 2023

Primary Completion

December 1, 2025

Study Completion (Estimated)

March 1, 2030

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)