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

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. Identifier: NCT02725528
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : September 18, 2018
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Achilleas Thoma, McMaster University

Brief Summary:
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 or disease Intervention/treatment Phase
Dupuytren's Disease Drug: collagenase injection Procedure: limited palmar fasciectomy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
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
Actual Study Start Date : July 8, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: collagenase 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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Canadian Citizen
  2. 18 years of age or older
  3. 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)
  4. Demonstrated inability to simultaneously place the affected finger and palm flat on a table
  5. 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.

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 identifier (NCT number): NCT02725528

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Contact: Achilleas Thoma, MD MSc FRCSC 905-523-0019

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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 Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Achilleas Thoma, MD MSc FRCSC    905-523-0019   
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
The Physicians' Services Incorporated Foundation
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Principal Investigator: Achilleas Thoma, MD MSc FRCSC McMaster University

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Responsible Party: Achilleas Thoma, Dr. Achllieas Thoma, McMaster University Identifier: NCT02725528     History of Changes
Other Study ID Numbers: PSI 2016-03
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Dupuytren Contracture
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Muscular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases