Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture

Phase 4

• Conditions: Dupuytrens Contracture
• Interventions: Procedure: percutaneous needle fasciotomy; Drug: xiapex

• Registration Number: NCT02476461
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Prospective randomized study between Percutanous Needle Fasciotomy and Xiapex for Dupuytrens contracture.

A total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or Xiapex treatment.

The patients randomized to xiapex treatment are treated as described in the product manual. Extentin treatment after one day.

The patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: A littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. After thet we use a 19G needle to cut the cord sufficient number sites to extend the finger.

The patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. Investigators record contracture size, quicq-DASH, pain (VAS) and hand disability (VAS) pretreatment and at all controlls. At 3 weeks investigators register procedure complain. Side effects and complications, and advere effects are also to be investigated.

Our hypothesis is that it is no difference between the two methods in regard of contracture size after five years.

Inclution criteria: Symptomatic primary Dupuytrens contracture with palpable cord in one to three fingers, involving MCP, and total contracture size is over 30 degrees. Patient age over 18 years.

Exclution criteria:

Previously treated Dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs Other symptomatic injury or disease influencingf hand function ASA\>3 Expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial

Study Timeline

• Status Verified: 2015-04
• Study Start: 2015-04
• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-06-16
• Last Update Submitted: 2015-06-16
• Study First Posted: 2015-06-19
• Last Update Posted: 2015-06-19
• Primary Completion: 2016-04
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PNF	percutaneous needle fasciotomy	percutaneous needle fasciotomi is performed at affected cords
xiapex	xiapex	1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual

Primary Outcome Measures

Name	Time	Method
contracture size (degrees)	five years

Secondary Outcome Measures

Name	Time	Method
contracture size	post treatment	Contracture size mesured in degrees in each finger joint

Trial Locations

Locations (1)

Oslo Universitetssykehus; 🇳🇴 Oslo, Norway