NCT03331926

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

October 26, 2017

Last Update Submit

April 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in extension deficit from baseline to FU in MCP and PIP joints after treatment

    Minimum one year after treatment

Interventions

XiapexDRUG

Follow-up of effect of treatment

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who received Xiapex treatment in Horsens from 2013 to May 2016 with a least 1 years of followup.

You may qualify if:

  • dupuytrens disease
  • xiapex treatment

You may not qualify if:

  • \- demens/other psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hartig-Andreasen C, Schroll L, Lange J. Clostridium histolyticum as first-line treatment of Dupuytren's disease. Dan Med J. 2019 Feb;66(2):A5527.

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

xiapex

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Charlotte Hartig-Andreasen, MD, PhD

    Regionshospitalet Horsens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research secretary

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 6, 2017

Study Start

January 1, 2017

Primary Completion

May 31, 2017

Study Completion

December 31, 2019

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share