Comparing Short-term Function and Pain After Treatment With Collagenase Clostridium Histolyticum or Percutaneous Needle Aponeurotomy for Dupuytren's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Percutaneous Needle Aponeurotomy
- Conditions
- Dupuytren Disease
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Daily Pain and Function Scales
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Previous treatment for Dupuytren's disease
- •Type 2 Diabetes Mellitus
- •Pre-existing hand condition, previous hand surgery or trauma
Arms & Interventions
Percutaneous Needle Aponeurotomy
Patients who choose to undergo percutaneous needle aponeurotomy (PNA) for primary treatment of Dupuytren's disease
Intervention: Percutaneous Needle Aponeurotomy
Xiaflex
Patients who choose to receive Collagenase clostridium histolyticum injection (drug name Xiaflex) for primary treatment of Dupuytren's disease.
Intervention: Collagenase clostridium histolyticum
Outcomes
Primary Outcomes
Daily Pain and Function Scales
Time Frame: Day 28
Brief Michigan Hand Questionnaire (brief MHQ)
Time Frame: Day 28
Unite Rhumatologique des Affections de la Main (URAM) scale
Time Frame: Day 28