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

Phase 1

Recruiting

Conditions: Dupuytren Concrature
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: CTIS2022-501549-57-00

Lead Sponsor: Regionshospitalet Horsens

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

>= 45 years, DC of = 20° passive extension deficit (PED) in MCP joint measured with a finger goniometer, DC of either II-V finger, Well-defined/palpable cord, Received oral and written information of the trial prior to inclusion, Willingness to participate and signed written informed patient consent form

Exclusion Criteria

Legally incapacitated, Rheumatoid arthritis, Amyloidosis or mucopolysaccharidosis, Unable to communicate, cooperate or participate in follow-up, Unable to speak or read Danish language, Previous study inclusion with another finger ray, Isolated PIP or 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this trial is to compare Percutaneous Needle Fasciotomy (PNF) with corticosteroid injection (intervention) and PNF with saline injection (placebo) for Dupuytren Contracture affecting the metacarpophalangeal joint. <br><br>The primary objective of the study is to investigate if PNF with corticosteroid injection yield better long-term results, defined as reduced recurrence rate (=20° passive extension deficit) compared with PNF alone;Secondary Objective: To investigate complications following PNF +/- corticosteroid injection, To investigate if PNF with corticosteroid injection entails a higher rate of infection, To compare cost-benefit of PNF +/- corticosteroid injcetion;Primary end point(s): Recurrence, defined as =20° passive extension deficit in metacarpophalangeal joint

Secondary Outcome Measures

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