Clinical trial · Interventional
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture
Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur
NCT02476461CI-TRIAL-00018308PNFvsxiapexunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Contracture size after one and three years, and subjective hand function is also to be investigated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dupuytrens Contracture | Palmar Fibromatosis | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| percutaneous needle fasciotomy | Procedure | — | UNRESOLVED |
| xiapex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- xiapex
- description
- 1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual
- interventionNames
- Drug: xiapex
- type
- EXPERIMENTAL
- label
- PNF
- description
- percutaneous needle fasciotomi is performed at affected cords
- interventionNames
- Procedure: percutaneous needle fasciotomy
Primary outcomes (1)
- measure
- contracture size (degrees)
- timeFrame
- five years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * symptomatic Dupuytrens contracture with palpable cord, involving MCP, total contracture size over 30 degrees Exclusion Criteria: * previous treated dupuytrens contracture same hand * more than tree fingers involvement * we will not include thumbs * other things affecting hand function * ASA\>3 * expected to live under five years * Tetracycline treatment within two weeks * pregnancy * nursing * allergy to clostridium histolyticum * participant in other trial
References
Publications (0)
Data not yet available
No reference posted for this study.