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

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