Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture (PNFvsxiapex)

Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur

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.

Study Overview

• Status: Unknown
• Conditions: Dupuytrens Contracture
• Intervention / Treatment: Drug: xiapex; Procedure: percutaneous needle fasciotomy

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: hallgeir bratberg, MD; Phone Number: +4790578848; Email: hbratber@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo Universitetssykehus
    • Contact: hallgeir bratberg, MD; Phone Number: +4790578848; Email: hbratbe@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: xiapex; 1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual	Drug: xiapex; Other Names: clostridium histolyticum
Experimental: PNF; percutaneous needle fasciotomi is performed at affected cords	Procedure: percutaneous needle fasciotomy; Other Names: PNF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
contracture size (degrees)	five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
contracture size	Contracture size mesured in degrees in each finger joint	post treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
contracture size (degrees)	contracture size mesured in degrees in each finger joint	one year
contracture size (degrees)	contracture size mesured in degrees in each finger joint	three years
quick-Dash	Quick-DASH functional score measured in points.	one, three and five years
Pain	Visual Analogue score	one, three, five years
Hand disability	Visual Analogue score	oen, three, five years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: hallgeir bratberg, MD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: percutanepus needle fasciotomy; xiapex; clostridium histolyticum
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Dupuytren Contracture
• Other Study ID Numbers: 1234 (Department of Defense)