Clinical trial · Interventional
Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF
A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.
- 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)
Aim: Clinical RCT comparing functional results and recurrence rate following enzymatic treatment vs. needle aponeurotomy. Materials and methods: 30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint. Patients with primary disease of the hand. Total of 80 patients needed to detect difference of 13.5°. 1\) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks, 16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ, VAS pain and VAS patient satisfaction. Total passive extension contracture reduction, recurrence rate and registration of complications.
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 |
|---|---|---|---|
| Dupuytren Contracture | Palmar Fibromatosis | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Needle aponeurotomy | Procedure | — | UNRESOLVED |
| Xiapex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Needle aponeurotomy
- description
- percutaneous transection or pretendinous palmar dupytren cord
- interventionNames
- Procedure: Needle aponeurotomy
- type
- ACTIVE_COMPARATOR
- label
- Xiapex
- description
- Injection of 0.58 mg collagenase into pretendinous palmar dupytren cord
- interventionNames
- Drug: Xiapex
Primary outcomes (1)
- measure
- Reduction in Total Passive Extension Deficit
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary Dd disease (no earlier treatment for this condition of the hand involved) * Single digit involvement, one of the three ulnar digits * Average norwegian language skills. * MCPJ contracture of 30 degrees or more and less than 20 degree involvement of the adjacent PIPJ * Minimum 18 y.o. Exclusion Criteria: * Involvement of 2 fingers/joints * Earlier treatment for Dd disease of the same hand, affection of addjecent PIPJ of 20 degrees or mor * Pregnancy * Ongoing treatment with platelet inhibitors * Treatment with tetracycline 2 weeks prior to treatment date * Poor norwegian language skills * Participation in other studies 4 weeks prior or after treatment date * "Need to treat" of both hands
References
Publications (0)
Data not yet available