Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03331926
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : April 22, 2020
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03331926


Sponsors and Collaborators
Jeppe Lange
Investigators
Layout table for investigator information
Principal Investigator: Charlotte Hartig-Andreasen, MD, PhD Regionshospitalet Horsens
Publications of Results:
Layout table for additonal information
Responsible Party: Jeppe Lange, Research secretary, Horsens Hospital
ClinicalTrials.gov 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for 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