Clinical trial
DupuytrEn Treatment EffeCtiveness Trial (DETECT): Needle Fasciotomy, Surgery or Collagenase Injection for Dupuytren's Contracture
Name
R17022M
Description
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.
Trial arms
Trial start
2017-09-15
Estimated PCD
2026-05-31
Trial end
2031-05-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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.
Arms:
Percutaneous needle fasciotomy (PNF)
Other names:
Percutaneous needle aponeurotomy
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.
Arms:
Collagenase clostridium histolyticum (CCH)
Other names:
[Xiapex]
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.
Arms:
Collagenase clostridium histolyticum (CCH), Limited fasciectomy (LF), Percutaneous needle fasciotomy (PNF)
Other names:
Limited aponeurectomy
Size
302
Primary endpoint
Rate of success
5 year follow-ups
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "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.", 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 302, 'type': 'ACTUAL'}}
Updated at
2024-03-15
1 organization
1 product
1 indication
Organization
Tampere UniversityIndication
Dupuytren's Contracture