Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture (PNFvsxiapex)
Primary Purpose
Dupuytrens Contracture
Status
Unknown status
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
xiapex
percutaneous needle fasciotomy
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytrens Contracture focused on measuring percutanepus needle fasciotomy, xiapex, clostridium histolyticum
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
Sites / Locations
- Oslo UniversitetssykehusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
xiapex
PNF
Arm Description
1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual
percutaneous needle fasciotomi is performed at affected cords
Outcomes
Primary Outcome Measures
contracture size (degrees)
Secondary Outcome Measures
contracture size
Contracture size mesured in degrees in each finger joint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02476461
Brief Title
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture
Acronym
PNFvsxiapex
Official Title
Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytrens Contracture
Keywords
percutanepus needle fasciotomy, xiapex, clostridium histolyticum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
xiapex
Arm Type
Active Comparator
Arm Description
1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual
Arm Title
PNF
Arm Type
Experimental
Arm Description
percutaneous needle fasciotomi is performed at affected cords
Intervention Type
Drug
Intervention Name(s)
xiapex
Other Intervention Name(s)
clostridium histolyticum
Intervention Type
Procedure
Intervention Name(s)
percutaneous needle fasciotomy
Other Intervention Name(s)
PNF
Primary Outcome Measure Information:
Title
contracture size (degrees)
Time Frame
five years
Secondary Outcome Measure Information:
Title
contracture size
Description
Contracture size mesured in degrees in each finger joint
Time Frame
post treatment
Other Pre-specified Outcome Measures:
Title
contracture size (degrees)
Description
contracture size mesured in degrees in each finger joint
Time Frame
one year
Title
contracture size (degrees)
Description
contracture size mesured in degrees in each finger joint
Time Frame
three years
Title
quick-Dash
Description
Quick-DASH functional score measured in points.
Time Frame
one, three and five years
Title
Pain
Description
Visual Analogue score
Time Frame
one, three, five years
Title
Hand disability
Description
Visual Analogue score
Time Frame
oen, three, five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hallgeir bratberg, MD
Phone
+4790578848
Email
hbratber@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hallgeir bratberg, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo Universitetssykehus
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hallgeir bratberg, MD
Phone
+4790578848
Email
hbratbe@ous-hf.no
12. IPD Sharing Statement
Learn more about this trial
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture
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