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

Dupuytren Contracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331926
• Other study ID #: XIAPEX FOLLOWUP
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: Horsens Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: December 31, 2019
• Est. primary completion date: May 31, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• dupuytrens disease

• xiapex treatment

Exclusion Criteria:

• demens/other psychiatric diseases

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture

Intervention

Drug:
• Xiapex
Follow-up of effect of treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jeppe Lange

References & 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). pii: A5527. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in extension deficit from baseline to FU in MCP and PIP joints after treatment		Minimum one year after treatment