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Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease

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. Read our disclaimer for details. Identifier: NCT03331926
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : April 22, 2020
Information provided by (Responsible Party):
Jeppe Lange, Horsens Hospital

Brief Summary:
To evaluate the effect of collagenase clostridium histolyticum treatment at the Department of Orthopaedic surgery at Horsens Regional Hospital after minimum one-year follow-up (FU).

Condition or disease Intervention/treatment
Dupuytren Contracture Drug: Xiapex

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Study Type : Observational
Actual Enrollment : 199 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Collagenase Clostridium Histolytic is a Common Treatment of MCP and PIP Joint Contractures in Dupuytren Disease. A 1 to 4 Year Followup Study of 198 Joints
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Xiapex
    Follow-up of effect of treatment

Primary Outcome Measures :
  1. Change in extension deficit from baseline to FU in MCP and PIP joints after treatment [ Time Frame: Minimum one year after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients who received Xiapex treatment in Horsens from 2013 to May 2016 with a least 1 years of followup.

Inclusion Criteria:

  • dupuytrens disease
  • xiapex treatment

Exclusion Criteria:

- demens/other psychiatric diseases

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 identifier (NCT number): NCT03331926

Sponsors and Collaborators
Jeppe Lange
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Principal Investigator: Charlotte Hartig-Andreasen, MD, PhD Regionshospitalet Horsens
Publications of Results:
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Responsible Party: Jeppe Lange, Research secretary, Horsens Hospital Identifier: NCT03331926    
Other Study ID Numbers: XIAPEX FOLLOWUP
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Connective Tissue Diseases