Trial Comparing Treatment Strategies in Dupuytren's Contracture

• Status: Active, not recruiting
• Trial end date: 2031-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tampere University; University of Tampere
• Collaborators: Central Hospital of Central Finland; Finnish Institute for Health and Welfare; Hatanpää Hospital; Helsinki University Central Hospital; Kuopio University Hospital; Medcare Plc; National Institute for Health and Welfare, Finland; Oulu University Hospital; Tampere University Hospital; Turku University Hospital

Criteria

Inclusion Criteria:

• patients with ≥20° passive extension deficit (PED) in metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint, or TPED of ≥30° in MP and PIP joints 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

• TPED > 135° (Tubiana stage 4) in finger to be treated

• rheumatoid arthritis

• previous fracture in finger to be treated, which affects range of motion of MP or PIP joint

• age > 80 years