Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture

Dupuytrens Contracture Clinical Trial

— PNFvsxiapex  

Official title:

Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02476461
• Other study ID #: 1234
• Status: Recruiting
• Phase: Phase 4
• First received: June 5, 2015
• Last updated: June 16, 2015
• Start date: April 2015
• Est. completion date: January 2021

Study information

• Verified date: April 2015
• Source: Oslo University Hospital
• Contact: hallgeir bratberg, MD
• Phone: +4790578848
• Email: hbratber[@]ous-hf.no
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2021
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytrens Contracture

Intervention

Drug:
• xiapex

Procedure:
• percutaneous needle fasciotomy

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehus	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	contracture size (degrees)	contracture size mesured in degrees in each finger joint	one year	No
Other	contracture size (degrees)	contracture size mesured in degrees in each finger joint	three years	No
Other	quick-Dash	Quick-DASH functional score measured in points.	one, three and five years	No
Other	Pain	Visual Analogue score	one, three, five years	No
Other	Hand disability	Visual Analogue score	oen, three, five years	No
Primary	contracture size (degrees)		five years	No
Secondary	contracture size	Contracture size mesured in degrees in each finger joint	post treatment	No