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Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's (EXTEND)

This study is not yet open for participant recruitment.
Verified March 2016 by McMaster University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02725528
First Posted: April 1, 2016
Last Update Posted: April 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
McMaster University
  Purpose
This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms of improved quality of life and reducing recurrence of the disease without serious complications. Since collagenase injections are costly it is also important to know if this novel intervention is cost-effective from the patient, Ministry of Health and societal perspectives.

Condition Intervention Phase
Dupuytren's Disease Procedure: collagenase injection Procedure: limited palmar fasciectomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized Controlled Trial Comparing The Clinical Effectiveness and Cost-Effectiveness of Collagenase Injection (Xiaflex) and Palmar Fasciectomy in the Management of Dupuytren's Disease

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • health-related quality of life (HRQL) using the Michigan Hand Outcomes Questionnaire (MHQ) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • HRQL measured with the Health Utility Index Mark 3 (HUI3) of Health) [ Time Frame: 1 year ]
  • HRQL measured with the Unité Rhumatologique des Affections de la Main (URAM) [ Time Frame: 1 year ]
  • HRQL measured with the Southampton Dupuytren's Scoring Scheme (SDSS) [ Time Frame: 1 year ]
  • Quality Adjusted Life Years (QALY) measured with the Health Utility Index Mark 3 (HUI3) [ Time Frame: 1 year ]
  • Self-reported healthcare utilization [ Time Frame: 1 year ]
  • Range of motion (ROM) of hand joints [ Time Frame: 1 year ]
  • Recurrence rates [ Time Frame: 1 year ]

Estimated Enrollment: 128
Study Start Date: November 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: collagenase injection
This procedure will be performed either in a minor procedure room or the hand clinic as per surgeon's routine practice. Collagenase will be administered with or without local anesthesia. As this is a pragmatic study there may be more than one digit injected at a time just as surgery occurs on more than one digit at a time. A recently published study by Gaston et al confirmed that two concurrent injections of collagenase to 2 affected joints in the same hand are generally well tolerated and the frequency of most adverse events (AEs) is similar to those reported in studies that use single sequential injections.
Procedure: collagenase injection
injection
Other Name: enzyme, collagenase clostridium histolyticum, xiaflex
Active Comparator: limited palmar fasciectomy
The Dupuytren's cord will be excised under local anesthesia in a minor procedure room setting or main operating room under local or general anesthetic depending on the complexity of the disease and the surgeon's routine. As this is a pragmatic study comparison of collagenase injections (novel intervention) to limited palmar fasciectomy as it is actually presently performed in all settings academic or community (local in minor room or general/local anesthetic in the main operating room) will be examined. Surgery will be performed according to the operating surgeon's preferred technique i.e. zig-zag Brunner incision or straight incision with z-plasty closure of the skin.
Procedure: limited palmar fasciectomy
surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Dupuytren's contracture of the metacarpophalangeal (MCP) joint or of the proximal interphalangeal (PIP) joint with a fixed flexion contracture of 20º or greater in at least 1 finger (not the thumb)
  3. Demonstrated inability to simultaneously place the affected finger and palm flat on a table
  4. Able to understand and communicate in English

Exclusion Criteria:

  1. Previous treatment of the primary joint within 90 days of study inclusion
  2. Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel release, stenosing tenosynovitis release)
  3. Persistent extension deficit from a previous surgery of the same digit
  4. Any chronic muscular or neuromuscular disorder affecting wrist or hand
  5. Patient generally unfit for surgery
  6. Patient with specific treatment preference
  7. Bleeding disorder or recent stroke
  8. Allergy to collagenase
  9. Collagenase treatment or treatment with any investigational drug within 30 days of study inclusion
  10. Use of a tetracycline derivative within 14 days of first dose of study drug (because tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs [i.e., matrix metalloproteinases])
  11. Pregnant or breast feeding patients
  12. Patients who do not have insurance coverage for collagenase injections
  13. Patients who are unable to provide informed consent or are unable to complete quality of life questionnaires due to mental capacity or neuro-psychological problems.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725528


Contacts
Contact: Achilleas Thoma, MD MSc FRCSC 905-523-0019 athoma@mcmaster.ca

Locations
Canada, Ontario
Hamilton Health Sciences Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: James Bain, MD    905-521-2100 ext 73222      
St. Joseph's Healthcare / McMaster University Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Achilleas Thoma, MD MSc FRCSC    905-523-0019    athoma@mcmaster.ca   
Principal Investigator: Achilleas Thoma, MD MSc FRCSC         
St. Joseph's Hospital Not yet recruiting
Hamilton, Ontario, Canada
Contact: Carolyn Levis, MD    905-308-9419      
St. Joseph's Healthcare Not yet recruiting
London, Ontario, Canada, N6A 4V2
Contact: Bing Gan, MD    519-646-6097      
Markham Stouffville Hospital Not yet recruiting
Markham, Ontario, Canada, L6B 0T1
Contact: Tara Lynn Teshima, MD    289-597-6775      
679 Davis St. Suite 209 Not yet recruiting
Newmarket, Ontario, Canada, L3Y 5G8
Contact: Bimpe Ayeni, MD    905-853-6644      
Halton Healthcare Services Not yet recruiting
Oakville, Ontario, Canada, L6J 0B2
Contact: Nancy de Kleer, MD    905-901-9545      
Oakville Trafalgar Hospital Not yet recruiting
Oakville, Ontario, Canada
Contact: Rodger Shortt, MD    905-849-4282      
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Murray Allen         
North York General Hospital Not yet recruiting
Toronto, Ontario, Canada, M2J 1V1
Contact: Yasser El-Sheikh, MD    416-782-7788      
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Achilleas Thoma, MD MSc FRCSC McMaster University
  More Information

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02725528     History of Changes
Other Study ID Numbers: PSI 2016-03
First Submitted: March 22, 2016
First Posted: April 1, 2016
Last Update Posted: April 1, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Dupuytren Contracture
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