Trial Comparing Treatment Strategies in Dupuytren's Contracture

NCT ID: NCT03192020

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2031-05-31

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.

Detailed Description

Dupuytren's contracture (DC) is a fibroproliferative disorder of the palmar fascia, which in time leads to flexion contracture in one or more fingers. Etiology of the disease is still unknown, but it strongly seems that genetic factors play a major role. DC is associated most commonly with Caucasian population groups from Northern Europe. The estimated global prevalence among whites is 3% to 6% and increases with age. Men women ratio is 7:1. There is no definitive cure for DC. The treatment aims at relieving the symptoms by releasing the contracture by percutaneous or operative techniques.

The investigators planned a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial comparing the cost-effectiveness of 1) collagenase clostridium histolyticum followed by limited fasciectomy in non-responsive cases, 2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and 3) primary limited fasciectomy in short- and long-term follow-up in DC.

Protocol is approved by Tampere university hospital institutional review board and Finnish Medicine Agency (Fimea). All patients will give written informed consent. The results of the trial will be disseminated as published articles in peer-reviewed journals.

Treatment of Duputren's contracture aims at reducing the functional deficit caused by the contracture. Recurrence is almost inevitable if the follow-up is long enough. Therefore, the investigators aim to analyze the effectiveness of three different treatment strategies in long-term follow-up, in addition to short-term follow-up, which include multiple interventions rather than just single intervention. The investigators chose a pragmatic primary outcome, which comprises both objective and subjective standpoint and reflects the needs of the patients as well as goals of the healthcare system. Furthermore, our short-term results give good high quality level evidence of effectiveness of all the three treatments and long-term follow-up a good perspective to the cost-effectiveness of the strategies.

Conditions

Dupuytren Contracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Percutaneous needle fasciotomy (PNF)

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

Group Type: EXPERIMENTAL

Percutaneous needle fasciotomy (PNF)

Intervention Type: 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.

Limited fasciectomy (LF)

Intervention Type: 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.

Collagenase clostridium histolyticum (CCH)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Limited fasciectomy (LF)

Intervention Type: 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.

Limited fasciectomy (LF)

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

Group Type: ACTIVE_COMPARATOR

Limited fasciectomy (LF)

Intervention Type: 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.

Interventions

Percutaneous needle fasciotomy (PNF)

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.

Intervention Type: PROCEDURE

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

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.

Intervention Type: DRUG

Limited fasciectomy (LF)

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.

Intervention Type: PROCEDURE

Other Intervention Names

Percutaneous needle aponeurotomy; [Xiapex]; Limited aponeurectomy

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Finland Hospital District

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

Oulu University Hospital

OTHER

Sponsor Role: collaborator

Medcare Oy

OTHER

Sponsor Role: collaborator

Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role: collaborator

Orton Orthopaedic Hospital

OTHER

Sponsor Role: collaborator

Tampere University

OTHER

Sponsor Role: lead

Responsible Party

Olli Leppänen

M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikko P Räisänen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

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

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

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

Role: PRINCIPAL_INVESTIGATOR

Central Finland Central Hospital

Hannu Kautiainen, MSc

Role: PRINCIPAL_INVESTIGATOR

Medcare Ltd

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

Role: PRINCIPAL_INVESTIGATOR

Finnish Institute for Health and Welfare

Locations

Central Hospital of Central Finland

Jyväskylä, Central Finland, Finland

Oulu University hospital

Oulu, North Ostrobothnia, Finland

Kuopio University hospital

Kuopio, Northern Savonia, Finland

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Turku University Hospital

Turku, Southwest Finland, Finland

Helsinki University hospital

Helsinki, Uusimaa, Finland

Countries

Finland

References

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.

Reference Type: BACKGROUND

PMID: 29599391 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38346307 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Study Documents

Document Type: Study Protocol

Protocol in BMJ Open access

View Document

Other Identifiers

R17022M

Identifier Type: -

Identifier Source: org_study_id