Short-term Function and Pain After Treatment for Dupuytren's Disease

• Conditions: Dupuytren Disease
• Interventions: Procedure: Percutaneous Needle Aponeurotomy; Drug: Collagenase clostridium histolyticum

• Registration Number: NCT02301078
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

This study will evaluate short-term pain and function associated with percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in patients with Dupuytren's disease. Scores on outcome measures will be compared between groups to determine whether treatments differ in terms of hand function and pain during the early post-treatment period.

Detailed Description

Percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum are two non-invasive treatment options for patients with Dupuytren's disease. While PNA has been offered for decades, injectable collagenase is relatively new. The effectiveness of each treatment has been compared in the literature; however, recovery, in terms of pain and short-term function has not been formally evaluated. The objective of this study is to objectively compare short-term function and pain outcomes associated with each of these two procedures in patients presenting with untreated Dupuytren's disease.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-25
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06
• Primary Completion: 2017-10
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult
• Dupuytren's disease diagnosis
• Consented to either percutaneous needle aponeurotomy or Xiaflex injection (patient choice)
• Able to read/write/speak English
• Must have an email address

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Exclusion Criteria

• Previous treatment for Dupuytren's disease
• Type 2 Diabetes Mellitus
• Pre-existing hand condition, previous hand surgery or trauma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous Needle Aponeurotomy	Percutaneous Needle Aponeurotomy	Patients who choose to undergo percutaneous needle aponeurotomy (PNA) for primary treatment of Dupuytren's disease
Xiaflex	Collagenase clostridium histolyticum	Patients who choose to receive Collagenase clostridium histolyticum injection (drug name Xiaflex) for primary treatment of Dupuytren's disease.

Primary Outcome Measures

Name	Time	Method
Brief Michigan Hand Questionnaire (brief MHQ)	Day 28
Unite Rhumatologique des Affections de la Main (URAM) scale	Day 28
Daily Pain and Function Scales	Day 28

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery; 🇨🇦 Toronto, Ontario, Canada