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

2022-501549-57-00 Protocol 2022-985 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 10 Jan 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol 2022-985

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 400
Countries 1
Sites 2

Dupuytren Concrature

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. The primary objective of the study is to investigate if PNF with corticosteroid injection…

Key facts

Sponsor
Region Midtjylland
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
10 Jan 2023 → ongoing
Decision date (initial)
2022-10-12
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
The Danish Rheumatism Association (200,000 DKK) · Department of Orthopedic Surgery, Horsens Regional Hospital. Denmark · A. P. Møller Fonden, Denmark (90,000 DKK) · The Danish Medical Association Foundation (95,665 DKK) · Elective Surgery Centre, Silkeborg Regional Hosiptal. Denmark · Department of Orthopedic Surgery, Randers Regional Hospital. Denmark

External identifiers

EU CT number
2022-501549-57-00
ClinicalTrials.gov
NCT05440240

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

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.

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 objectives 3

  1. To investigate complications following PNF +/- corticosteroid injection
  2. To investigate if PNF with corticosteroid injection entails a higher rate of infection
  3. To compare cost-benefit of PNF +/- corticosteroid injcetion

Conditions and MedDRA coding

Dupuytren Concrature

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. >= 45 years
  2. DC of ≥ 20° passive extension deficit (PED) in MCP joint measured with a finger goniometer
  3. DC of either II-V finger
  4. Well-defined/palpable cord
  5. Received oral and written information of the trial prior to inclusion
  6. Willingness to participate and signed written informed patient consent form

Exclusion criteria 13

  1. Legally incapacitated
  2. Previous study inclusion with another finger ray
  3. Isolated PIP or DIP joint contracture, defined as MCP joint contracture < 20° PED regardless of the deficit in the PIP or DIP joint
  4. Previous hand surgery of the affected finger for any reason
  5. Known allergy to the study medication
  6. Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion)
  7. Pregnant or lactation
  8. Insulin dependent diabetes mellitus
  9. Ongoing systemic infection or local infection at the site of the procedure
  10. Rheumatoid arthritis
  11. Amyloidosis or mucopolysaccharidosis
  12. Unable to communicate, cooperate or participate in follow-up
  13. Unable to speak or read Danish language

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 11

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Depo-Medrol 40 mg/1 ml Injektionssuspension

PRD1990133 · Product

Active substance
Methylprednisolone Acetate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
40 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
H02AB04 — METHYLPREDNISOLONE
Marketing authorisation
BE124537
MA holder
PFIZER S.A. (BELGIUM)
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

XYLOCAINE 10 mg/ml SANS CONSERVATEUR, solution injectable

PRD4875536 · Product

Active substance
Anhydrous Lidocaine Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N01BB02 — LIDOCAINE
Marketing authorisation
34009 342 239 7 6
MA holder
ASPEN PHARMA TRADING LIMITED
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

2 ml of isotonic saline injection (9 mg/ml)

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

59 Total trials 36 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Region Midtjylland
Address
Sundvej 30
City
Horsens
Postcode
8700
Country
Denmark

Scientific contact point

Organisation
Regionshospitalet Horsens
Contact name
Jeppe Lange

Public contact point

Organisation
Regionshospitalet Horsens
Contact name
Jeppe Lange

Third parties 1

OrganisationCity, countryDuties
Aarhus University
ORG-100028380
 Aarhus N, Denmark On site monitoring

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 400 2
Rest of world — 0 —

Investigational sites

Denmark

2 sites · Ongoing, recruiting
Silkeborg Regional Hospital
Elective Surgery Centre, Falkevej 1/3, 8600, Silkeborg
Regionshospitalet Horsens
Department of Orthopedic Surgery, Sundvej 30, 8700, Horsens

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2023-01-10 2023-01-10

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Patient Questionnaires 1
Protocol (for publication) Protocol RCT PNF 5
Protocol (for publication) ProtocolRCT_PNF_V05_07012026_track_changes 5
Recruitment arrangements (for publication) Recriutment and informed consent procedure 3.1
Subject information and informed consent form (for publication) Deltagerinformation 5
Subject information and informed consent form (for publication) Deltagerinformation RCT V05 07012026 Silkeborg track changes 5
Subject information and informed consent form (for publication) Forsgspersoners rettigheder 2
Subject information and informed consent form (for publication) Patientbrev v1 29092025 1
Subject information and informed consent form (for publication) Plan for information til patienter v2 07012026 2
Subject information and informed consent form (for publication) Samtykkeerklring 5
Summary of Product Characteristics (SmPC) (for publication) SmPC DepoMedrol 1
Summary of Product Characteristics (SmPC) (for publication) SmPC DepoMedrol 1
Summary of Product Characteristics (SmPC) (for publication) SmPC Xylocain 1
Summary of Product Characteristics (SmPC) (for publication) SmPC Xylocain 1
Synopsis of the protocol (for publication) Protokolresume DANSK 1
Synopsis of the protocol (for publication) Study synopsis ENGLISH 1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-08-02 Denmark Acceptable
2022-10-12
 2022-10-12
2 SUBSTANTIAL MODIFICATION SM-3 2025-08-28 Denmark Acceptable
2025-09-04
 2025-09-04
3 SUBSTANTIAL MODIFICATION SM-5 2026-01-07 Denmark Acceptable
2026-02-09
 2026-02-09