Back to resultsInjectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture
Primary Purpose
Dupuytrens Contracture
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Xiapex
Percutaneous needle fasciotomy
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytrens Contracture
Eligibility Criteria
Inclusion Criteria:
- DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
- Clearly defined strings
Exclusion Criteria:
- Allergies to used medication
- International Normalised Ratio more than 2.0
- Pregnancy and breastfeeding
- Previous treatment for DC in affected finger
- Former inclusion in the study with another string
- Activity in disease at time of study
- PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit
Sites / Locations
- Center for Planned surgery - Regionalhospital Silkeborg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Collagenase injection
Percutaneous needle fasciotomy
Arm Description
Injection of collagenase obtained from Clostridium Histolyticum in contracture string
PNF ad modum Lermusiaux and Debeyre
Outcomes
Primary Outcome Measures
Clinical improvement
Clinical improvement is defined as a contracture reduction 50% or more from baseline.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01538017
Brief Title
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture
Official Title
Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeppe Lange, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytrens Contracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagenase injection
Arm Type
Active Comparator
Arm Description
Injection of collagenase obtained from Clostridium Histolyticum in contracture string
Arm Title
Percutaneous needle fasciotomy
Arm Type
Active Comparator
Arm Description
PNF ad modum Lermusiaux and Debeyre
Intervention Type
Drug
Intervention Name(s)
Xiapex
Other Intervention Name(s)
XIAPEX® - Pfizer UK
Intervention Description
Collagenase Clostridium Histolyticum
Intervention Type
Procedure
Intervention Name(s)
Percutaneous needle fasciotomy
Intervention Description
Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Clinical improvement is defined as a contracture reduction 50% or more from baseline.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
Clearly defined strings
Exclusion Criteria:
Allergies to used medication
International Normalised Ratio more than 2.0
Pregnancy and breastfeeding
Previous treatment for DC in affected finger
Former inclusion in the study with another string
Activity in disease at time of study
PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeppe Lange, M.D.
Organizational Affiliation
Regionshospitalet Silkeborg
Official's Role
Study Director
Facility Information:
Facility Name
Center for Planned surgery - Regionalhospital Silkeborg
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture
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