Trial Comparing Treatment Strategies in Dupuytren's Contracture

NCT03192020 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: R17022M
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 6

Brief Summary

Trial is a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial. The research objective is to determine, which treatment strategy 1) primary percutaneous needle fasciotomy (PNF) followed by surgical limited fasciectomy (LF) in patients who do not respond to PNF, 2) primary collagenase clostridium histolyticym (CCH) followed by LF in patients who do not respond to CCH or 3) LF as the primary (and secondary) treatment modality is the most cost-effective in treating Dupuytren´s contracture. Short- and long-term results will be published.

Conditions

Dupuytren Contracture

Keywords

Hand; Xiapex; Xiaflex; Clostridium histolyticum collagenase; Needle; Surgery; Aponeurectomy; Aponeurotomy; Fasciotomy; Fasciectomy; Dupuytren's disease; Dupuytren's contracture; Contracture; Connective tissue disease

Outcome Measures

Primary Outcomes (1)

• Rate of success

  Success is a composite outcome comprising of 1) at least 50% contracture release from the recruitment and 2) patient is in patient accepted symptom state (PASS). PASS is defined by question: "Would you be satisfied and not in need for any other treatment if the functional impairment caused by the contracture would remain the same as it is today for the rest of your life?". Primary time point is five years' follow-up visit.

  5 year follow-ups

Secondary Outcomes (18)

• QuickDASH

  3 months, 2, 5 and 10 year follow-ups

• Perceived hand function

  3 months, 2, 5 and 10 year follow-ups

• Global rating

  3 months, 2, 5 and 10 year follow-ups

• EQ-5D-3L

  3 months, 2, 5 and 10 year follow-ups

• Rate of Patient Accepted Symptom State

  3 months, 2, 5 and 10 year follow-ups

Study Arms (3)

Percutaneous needle fasciotomy (PNF)

EXPERIMENTAL

PNF is a treatment in which the Dupuytren's contracture cord causing the contracture is not excised, but only divided with a hypodermic needle.

Procedure: Percutaneous needle fasciotomy (PNF); Procedure: Limited fasciectomy (LF)

Collagenase clostridium histolyticum (CCH)

EXPERIMENTAL

Generic name of the drug is collagenase clostridium histolyticum. Dosage form is injectable powder, dosage 0.58 mg and frequency is one injection in four weeks up to three times. One injection is performed normally at least to three different places in the cord.

Drug: Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]; Procedure: Limited fasciectomy (LF)

Limited fasciectomy (LF)

ACTIVE COMPARATOR

In LF, the thickened part of the palmar fascia causing the contracture is excised through skin incision.

Procedure: Limited fasciectomy (LF)

Interventions

Percutaneous needle fasciotomy (PNF) PROCEDURE

The division of the cord can be made under local anesthesia in the clinic and takes only a few minutes to perform. It can be performed whenever the cord is palpable. There are only puncture wounds left, and hence, the patient can start normal use of the hand the day after the procedure. If patient seeks for a treatment and the recurrence of the disease can not be treated by the PNF or patient is not willing to new PNF patient will be treated with LF.

Also known as: Percutaneous needle aponeurotomy

Percutaneous needle fasciotomy (PNF)

Limited fasciectomy (LF) PROCEDURE

LF is performed in general or regional anesthesia in operating room. Constricting cords will be excised under direct vision. LF has been the dominant technique of surgical treatment. If patient seeks for a treatment the recurrence of the disease will be treated with LF as long as needed.

Also known as: Limited aponeurectomy

Collagenase clostridium histolyticum (CCH); Limited fasciectomy (LF); Percutaneous needle fasciotomy (PNF)

Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex] DRUG

CCH chemically dissolves type I collagen of which the cord is composed of. It is injected inside the cord at least three different places in the outpatient clinic and the cord can be ruptured by gently force after one to three days. If patient seeks for a treatment and the recurrence of the disease can not be treated by the CCH or patient is not willing to new CCH patient will be treated with LF.

Also known as: [Xiapex]

Collagenase clostridium histolyticum (CCH)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with ≥20° passive extension deficit in metacarpophalangeal (MPJ) or proximal interphalangeal joint (PIPJ), or TPED ≥30° in MPJ and PIPJ of finger/fingers II-V
• age \> 18 years
• palpable cord
• provision of informed consent
• ability to fill the Finnish versions of questionnaires.

You may not qualify if:

• recurrent contracture in the finger to be treated
• neurologic condition causing the loss of function of the finger to be treated
• contraindication for collagenase clostridium histolyticym (Xiapex/Xiaflex ®)
• pregnant or breast feeding
• total passive extension deficit \> 135° (Tubiana stage 4) in finger to be treated
• rheumatoid arthritis
• previous fracture in finger to be treated, which affects range of motion of MPJ or PIPJ
• age \> 80 years

Sponsors & Collaborators

• Tampere University: lead
• Central Finland Hospital District: collaborator
• Turku University Hospital: collaborator
• Tampere University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Oulu University Hospital: collaborator
• Medcare Oy: collaborator
• Finnish Institute for Health and Welfare: collaborator
• Orton Orthopaedic Hospital: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (6)

Central Hospital of Central Finland

Jyväskylä, Central Finland, 40620, Finland

Location

Oulu University hospital

Oulu, North Ostrobothnia, 90220, Finland

Location

Kuopio University hospital

Kuopio, Northern Savonia, 70029, Finland

Location

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

Turku University Hospital

Turku, Southwest Finland, 20521, Finland

Location

Helsinki University hospital

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (2)

• Raisanen MP, Karjalainen T, Goransson H, Reito A, Kautiainen H, Malmivaara A, Leppanen OV. DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture. BMJ Open. 2018 Mar 28;8(3):e019054. doi: 10.1136/bmjopen-2017-019054.

  PMID: 29599391 BACKGROUND

• Raisanen MP, Leppanen OV, Soikkeli J, Reito A, Malmivaara A, Buchbinder R, Kautiainen H, Kaivorinne A, Stjernberg-Salmela S, Lappalainen M, Luokkala T, Ponkko A, Taskinen HS, Paakkonen M, Jaatinen K, Juurakko J, Karjalainen VL, Karjalainen T. Surgery, Needle Fasciotomy, or Collagenase Injection for Dupuytren Contracture : A Randomized Controlled Trial. Ann Intern Med. 2024 Mar;177(3):280-290. doi: 10.7326/M23-1485. Epub 2024 Feb 13.

  PMID: 38346307 RESULT

MeSH Terms

Conditions

Dupuytren Contracture; Contracture; Connective Tissue Diseases

Interventions

Microbial Collagenase; xiapex

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Muscular Diseases; Musculoskeletal Diseases; Skin and Connective Tissue Diseases; Joint Diseases

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Mikko P Räisänen, M.D.

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• Harry J Göransson, M.D., Ph.D., adjunct professor

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• Aleksi RP Reito, M.D., Ph.D., adjunct professor

  Central Finland Central Hospital

  PRINCIPAL INVESTIGATOR

• Hannu Kautiainen, MSc

  Medcare Ltd

  PRINCIPAL INVESTIGATOR

• Antti OV Malmivaara, M.D., Ph.D., adjunct professor

  Finnish Institute for Health and Welfare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors who measured index, middle, ring and small fingers' flexion and extension degrees were blinded. Patients had opaque gloves in their hand when visiting the blinded outcome assessor. Due to the nature of the treatments it was not possible to blind patients, leading investigators or research assistants. To minimize any bias in interpreting the findings, we blinded treatment allocation in the draft results manuscript with groups labelled as A, B and C. The writing committee reached consensus on the interpretation of the findings prior to being unblinded to group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Model Details: This is a multicenter, randomized, outcome assessor blinded, three parallel armed (1:1:1), superiority trial comparing needle fasciotomy, collagenase injection and surgery as primary intervention for people with treatment-naïve Dupuytren's contracture with a five-year follow-up.

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 19, 2017
• Study Start: September 15, 2017
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2031
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after finishing the trial and it will be available for 15 years.
• Access Criteria: Request.

Locations

FI (6)