Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture

NCT ID: NCT02476461

Last Updated: 2015-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2021-01-31

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

Conditions

Dupuytrens Contracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

xiapex

1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual

Group Type: ACTIVE_COMPARATOR

xiapex

Intervention Type: DRUG

PNF

percutaneous needle fasciotomi is performed at affected cords

Group Type: EXPERIMENTAL

percutaneous needle fasciotomy

Intervention Type: PROCEDURE

Interventions

xiapex

Intervention Type: DRUG

percutaneous needle fasciotomy

Intervention Type: PROCEDURE

Other Intervention Names

clostridium histolyticum; PNF

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

hallgeir bratberg, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo Universitetssykehus

Oslo, Oslo County, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

hallgeir bratberg, MD

Role: CONTACT

hbratber@ous-hf.no

+4790578848

Facility Contacts

hallgeir bratberg, MD

Role: primary

hbratbe@ous-hf.no

+4790578848

Other Identifiers

1234

Identifier Type: -

Identifier Source: org_study_id