Recruiting

PNA & Collagenase

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT02301078

Conditions

Dupuytren Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Percutaneous Needle Aponeurotomy

Collagenase clostridium histolyticum

Study Details

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.

Conditions

Dupuytren Disease

Study ID

NCT02301078

Start date

Jul, 2014

Status verified date

Dec, 2016

Completion date

Nov, 2017

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Percutaneous Needle Aponeurotomy

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

Xiaflex

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

Interventions

Percutaneous Needle Aponeurotomy

single procedure (day 0)

Collagenase clostridium histolyticum

Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)

Primary outcome measure

  • Brief Michigan Hand Questionnaire (brief MHQ) [ Time Frame: Baseline ]
  • Unite Rhumatologique des Affections de la Main (URAM) scale [ Time Frame: Baseline ]
  • Daily Pain and Function Scales [ Time Frame: Baseline ]
  • Brief Michigan Hand Questionnaire (brief MHQ) [ Time Frame: Day 7 ]
  • Brief Michigan Hand Questionnaire (brief MHQ) [ Time Frame: Day 14 ]
  • Brief Michigan Hand Questionnaire (brief MHQ) [ Time Frame: Day 21 ]
  • Brief Michigan Hand Questionnaire (brief MHQ) [ Time Frame: Day 28 ]
  • Unite Rhumatologique des Affections de la Main (URAM) scale [ Time Frame: Day 7 ]
  • Unite Rhumatologique des Affections de la Main (URAM) scale [ Time Frame: Day 14 ]
  • Unite Rhumatologique des Affections de la Main (URAM) scale [ Time Frame: Day 21 ]
  • Unite Rhumatologique des Affections de la Main (URAM) scale [ Time Frame: Day 28 ]
  • Daily Pain and Function Scales [ Time Frame: Day 1 ]
  • Daily Pain and Function Scales [ Time Frame: Day 2 ]
  • Daily Pain and Function Scales [ Time Frame: Day 3 ]
  • Daily Pain and Function Scales [ Time Frame: Day 4 ]
  • Daily Pain and Function Scales [ Time Frame: Day 5 ]
  • Daily Pain and Function Scales [ Time Frame: Day 6 ]
  • Daily Pain and Function Scales [ Time Frame: Day 7 ]
  • Daily Pain and Function Scales [ Time Frame: Day 14 ]
  • Daily Pain and Function Scales [ Time Frame: Day 21 ]
  • Daily Pain and Function Scales [ Time Frame: Day 28 ]

Central Contacts and Locations

Locations

Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Catherine McMillan, MSc

catherine.mcmillan@sunnybrook.ca

Principal Investigator:

Paul A. Binhammer, MD, MSc

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 6, 2016

Last verified

Dec, 2016

Keywords

  • Dupuytren disease
  • needle aponeurotomy
  • collagenase

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2016-12-06.