We will compare two non-operative treatment options for Dupuytrens contracture

Prospective randomized trial between Percutaneous Needle Fasciotomy and Xiapex injection - PNF vs Xiapex

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000673-40-NO

Enrollment

Registered

2014-05-09

Start date

2015-01-06

Completion date

Unknown

Last updated

2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytrens contracture of the hand

Interventions

Trade Name: xiapex Product Name: xiapex Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Symptomatic Dupuytrens contracture with palpable cord, involving MCP joint, and total contracture > 30 degrees. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Eksklusjonskriterier: Tidligere operert Dupuytrens kontraktur på samme hånd. Mer enn tre behandlingstrengende affiserte stråler. Man vil ikke inkludere tomler. Andre tilstander i hånden som affiserer leddenes bevegelighet. ASA>3. Infeksjon/antibiotikabehandling. Kvinner i fertil alder må bruke prevensjonsmidler Age under 18 years Previous treated for Dupuytrens contracture in same hand max 3 rays not thumbs patients with other conditions affecting finger movement ASA>3 infection Pregnancy potential

Design outcomes

Primary

Measure	Time frame
Main Objective: We will compare Percutaneous Needle Fasciotomy and Xiapex injection for Dupuytrens contracture to se if the treatments art equal in regard of treating the contracture and in regard of recurrence. Main end point is at 5 years.;Secondary Objective: Postoperative contracture 1 year contracture 3 year contracture reoperation;Primary end point(s): Total finger contracture afteer 5 years;Timepoint(s) of evaluation of this end point: 5 year evaluation	—

Measure

Time frame

Main Objective: We will compare Percutaneous Needle Fasciotomy and Xiapex injection for Dupuytrens contracture to se if the treatments art equal in regard of treating the contracture and in regard of recurrence. Main end point is at 5 years.;Secondary Objective: Postoperative contracture 1 year contracture 3 year contracture reoperation;Primary end point(s): Total finger contracture afteer 5 years;Timepoint(s) of evaluation of this end point: 5 year evaluation

—

Secondary

Measure	Time frame
Secondary end point(s): postoperative contracture 1 year contracture 3 year contracture reoperation;Timepoint(s) of evaluation of this end point: treatment day 1 and 3 year examination	—

Countries

Norway

Contacts

Public Contacthallgeir bratberg

ous

hbratber@ous-hf.no+4722118080

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026