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

NCT ID: NCT02301078

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Dupuytren Disease

Keywords

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Dupuytren disease needle aponeurotomy collagenase

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Percutaneous Needle Aponeurotomy

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

Percutaneous Needle Aponeurotomy

Intervention Type PROCEDURE

single procedure (day 0)

Xiaflex

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

Collagenase clostridium histolyticum

Intervention Type DRUG

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

Interventions

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Percutaneous Needle Aponeurotomy

single procedure (day 0)

Intervention Type PROCEDURE

Collagenase clostridium histolyticum

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

Intervention Type DRUG

Other Intervention Names

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needle aponeurotomy fasciotomy Xiaflex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Catherine McMillan, MSc

Role: primary

Other Identifiers

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Pain and Function - PNA vs CCH

Identifier Type: -

Identifier Source: org_study_id