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

NCT02301078 | Unknown

• 1 other identifier: Pain and Function - PNA vs CCH
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Dupuytren disease; needle aponeurotomy; collagenase

Outcome Measures

Primary Outcomes (21)

• Brief Michigan Hand Questionnaire (brief MHQ)

  A validated patient-reported 12-item questionnaire pertaining to several aspects of hand function that is answered on 1 through 5 Likert scales. Higher scores indicate better hand function.

  Baseline

• Unite Rhumatologique des Affections de la Main (URAM) scale

  The URAM is a validated patient-reported 9-item functional assessment scale used clinically and for research purposes specific to patients with Dupuytren's disease. The resulting score quantifies Dupuytren's disease-related disability, with higher scores indicating higher level of disability.

  Baseline

• Daily Pain and Function Scales

  An emailed form asking participants to rate pain and function during the past 24 hours using two 1-5 Likert scales. Two additional questions to assess night splint compliance and pain medication (yes/no)

  Baseline

• Brief Michigan Hand Questionnaire (brief MHQ)

  Day 7

• Brief Michigan Hand Questionnaire (brief MHQ)

  Day 14

• Brief Michigan Hand Questionnaire (brief MHQ)

  Day 21

• Brief Michigan Hand Questionnaire (brief MHQ)

  Day 28

• Unite Rhumatologique des Affections de la Main (URAM) scale

  Day 7

• Unite Rhumatologique des Affections de la Main (URAM) scale

  Day 14

• Unite Rhumatologique des Affections de la Main (URAM) scale

  Day 21

• Unite Rhumatologique des Affections de la Main (URAM) scale

  Day 28

• Daily Pain and Function Scales

  Day 1

• Daily Pain and Function Scales

  Day 2

• Daily Pain and Function Scales

  Day 3

• Daily Pain and Function Scales

  Day 4

• Daily Pain and Function Scales

  Day 5

• Daily Pain and Function Scales

  Day 6

• Daily Pain and Function Scales

  Day 7

• Daily Pain and Function Scales

  Day 14

• Daily Pain and Function Scales

  Day 21

• Daily Pain and Function Scales

  Day 28

Study Arms (2)

Percutaneous Needle Aponeurotomy

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

Procedure: Percutaneous Needle Aponeurotomy

Xiaflex

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

Drug: Collagenase clostridium histolyticum

Interventions

Percutaneous Needle Aponeurotomy PROCEDURE

single procedure (day 0)

Also known as: needle aponeurotomy, fasciotomy

Percutaneous Needle Aponeurotomy

Collagenase clostridium histolyticum DRUG

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

Also known as: Xiaflex

Xiaflex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at Sunnybrook Health Sciences Centre choosing either percutaneous needle aponeurotomy or Xiaflex injection for treatment of Dupuytren's disease.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Fasciotomy; Microbial Collagenase

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: November 25, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

CA (1)