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

Sunnybrook Health Sciences Centre

Status: Unknown

Conditions: Dupuytren Disease

Treatments: Drug: Collagenase clostridium histolyticum; Procedure: Percutaneous Needle Aponeurotomy

Study type: Observational

Funder types: Other

Identifiers

NCT02301078

Pain and Function - PNA vs CCH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

60 participants in 2 patient groups

Percutaneous Needle Aponeurotomy

Description:

Patients who choose to undergo percutaneous needle aponeurotomy (PNA) for primary treatment of Dupuytren's disease

Treatment:

Procedure: Percutaneous Needle Aponeurotomy

Xiaflex

Description:

Patients who choose to receive Collagenase clostridium histolyticum injection (drug name Xiaflex) for primary treatment of Dupuytren's disease.

Treatment:

Drug: Collagenase clostridium histolyticum