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

R

Regionshospitalet Silkeborg

Status and phase

Enrolling
Phase 4

Conditions

Contracture
Joint Diseases
Dupuytren Contracture
Dupuytren's Disease
Neoplasms, Connective Tissue
Musculoskeletal Diseases
Neoplasm, Fibrous Tissue
Neoplasms by Histologic Type
Fibroma
Neoplasms
Connective Tissue Diseases
Neoplasms, Connective and Soft Tissue

Treatments

Other: Saline injection
Drug: Corticosteroid injection
Procedure: Percutaneous needle fasciotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05440240
2022-985
2022-501021-20-00 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

400 estimated patients

Sex

All

Ages

45 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

400 participants in 2 patient groups, including a placebo group

Corticosteroid injection
Active Comparator group
Description:
Percutaneous needle fasciotomy with corticosteroid injection
Treatment:
Procedure: Percutaneous needle fasciotomy
Drug: Corticosteroid injection
Saline injection
Placebo Comparator group
Description:
Percutaneous needle fasciotomy with saline injection
Treatment:
Procedure: Percutaneous needle fasciotomy
Other: Saline injection

Trial contacts and locations

1

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Central trial contact

Laura H Matthiesen, MS, PhD-student; Jeppe Lange, MD, PhD

Data sourced from clinicaltrials.gov

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