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

April 20, 2020 updated by: Jeppe Lange

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

Inclusion Criteria:

  • dupuytrens disease
  • xiapex treatment

Exclusion Criteria:

- demens/other psychiatric diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in extension deficit from baseline to FU in MCP and PIP joints after treatment
Time Frame: Minimum one year after treatment
Minimum one year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeppe Lange

Investigators

  • Principal Investigator: Charlotte Hartig-Andreasen, MD, PhD, Regionshospitalet Horsens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XIAPEX FOLLOWUP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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