Active — Not RecruitingPhase 4

Trial Comparing Treatment Strategies in Dupuytren's Contracture

Finland302 participantsStarted 2017-09-15

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of success

Timeframe: 5 year follow-ups

Trial details

NCT IDNCT03192020

SponsorTampere University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31