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

ConditionsDupuytren ContractureDupuytren's DiseaseContractureJoint DiseasesMusculoskeletal DiseasesFibromaNeoplasm, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue Diseases
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45-99
SponsorRegionshospitalet Silkeborg

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer

DC of either II-V finger

Well-defined/palpable cord

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Percutaneous needle fasciotomy

    Procedure/Surgery

    Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

  • Corticosteroid injection

    Drug

    Depo-Medrol

  • Saline injection

    Other intervention

    Isotonic saline

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Corticosteroid injectionActive comparator 2 interventions
Group B: Saline injectionPlacebo comparator 2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regionshospitalet Silkeborg

Lead sponsor

Source ClinicalTrials.gov
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