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Trial record 4 of 85 for:    dupuytren | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified April 2015 by Oslo University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02476461
First Posted: June 19, 2015
Last Update Posted: June 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Oslo University Hospital
  Purpose
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.

Condition Intervention Phase
Dupuytrens Contracture Drug: xiapex Procedure: percutaneous needle fasciotomy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • contracture size (degrees) [ Time Frame: five years ]

Secondary Outcome Measures:
  • contracture size [ Time Frame: post treatment ]
    Contracture size mesured in degrees in each finger joint


Other Outcome Measures:
  • contracture size (degrees) [ Time Frame: one year ]
    contracture size mesured in degrees in each finger joint

  • contracture size (degrees) [ Time Frame: three years ]
    contracture size mesured in degrees in each finger joint

  • quick-Dash [ Time Frame: one, three and five years ]
    Quick-DASH functional score measured in points.

  • Pain [ Time Frame: one, three, five years ]
    Visual Analogue score

  • Hand disability [ Time Frame: oen, three, five years ]
    Visual Analogue score


Estimated Enrollment: 50
Study Start Date: April 2015
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: xiapex
1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual
Drug: xiapex
Other Name: clostridium histolyticum
Experimental: PNF
percutaneous needle fasciotomi is performed at affected cords
Procedure: percutaneous needle fasciotomy
Other Name: PNF

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476461


Contacts
Contact: hallgeir bratberg, MD +4790578848 hbratber@ous-hf.no

Locations
Norway
Oslo Universitetssykehus Recruiting
Oslo, Norway, 0424
Contact: hallgeir bratberg, MD    +4790578848    hbratbe@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: hallgeir bratberg, MD Oslo University Hospital
  More Information

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02476461     History of Changes
Other Study ID Numbers: 1234
First Submitted: June 5, 2015
First Posted: June 19, 2015
Last Update Posted: June 19, 2015
Last Verified: April 2015

Keywords provided by Oslo University Hospital:
percutanepus needle fasciotomy
xiapex
clostridium histolyticum

Additional relevant MeSH terms:
Dupuytren Contracture
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases