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Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren Contracture Affecting the Metacarpophalangeal Joint. A Randomized Controlled Trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501549-57-00
Acronym
2022-985
Enrollment
400
Registered
2022-10-12
Start date
2023-01-10
Completion date
Unknown
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren Concrature

Brief summary

Recurrence, defined as ≥20° passive extension deficit in metacarpophalangeal joint

Detailed description

%-change in metacarpophalangeal (MCP) joint passiv exension deficit (PED), Straight MCP joint (0-5°), Passive extension deficit of MCP, PIP, DIP-joints, Total passive extension deficit, Maximal pulp-to-palm distance (mm), Tabletop test, Complications and Adverse Events (AEs), Reoperation, PROM score: "quick-DASH", "Southhampton Dupuytren Scoring Scheme", EQ-5D (EuroQol five dimension scale) for cost-benefit analysis, Global rating of change scale for patient satisfaction

Interventions

DRUG2 ml of isotonic saline injection (9 mg/ml)
DRUGXYLOCAINE 10 mg/ml SANS CONSERVATEUR
DRUGsolution injectable

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Recurrence, defined as ≥20° passive extension deficit in metacarpophalangeal joint

Secondary

MeasureTime frame
%-change in metacarpophalangeal (MCP) joint passiv exension deficit (PED), Straight MCP joint (0-5°), Passive extension deficit of MCP, PIP, DIP-joints, Total passive extension deficit, Maximal pulp-to-palm distance (mm), Tabletop test, Complications and Adverse Events (AEs), Reoperation, PROM score: "quick-DASH", "Southhampton Dupuytren Scoring Scheme", EQ-5D (EuroQol five dimension scale) for cost-benefit analysis, Global rating of change scale for patient satisfaction

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026