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Trial record 3 of 85 for:    dupuytren | Recruiting, Not yet recruiting, Available Studies

Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease

This study is currently recruiting participants.
Verified December 2016 by Justin Yeung, University of Calgary
Sponsor:
ClinicalTrials.gov Identifier:
NCT03000114
First Posted: December 21, 2016
Last Update Posted: December 21, 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):
Justin Yeung, University of Calgary
  Purpose

Dupuytren's disease is a non-curative, progressive disorder leading to function-impairing deformities of the hand. Although numerous treatments exist, the most common and widely accepted therapy is removal of diseased fascia. Surgery is limited by prolonged recovery time, and many patients require multiple surgeries throughout their life as the disease progresses, with repeat surgeries increasing the risk of complications.

Long recovery times and need for repeat surgeries has renewed interest in minimally invasive treatments for Dupuytren's disease. Percutaneous needle aponeurotomy (PNA) allows for rapid improvement in finger extension with minimal recovery time. The FDA approved collagenase clostridium histolyticum injection for Dupuytren's disease in 2010, which also allows for rapid increase in finger extension, also with minimal recovery time. Currently there is only one small study comparing PNA and collagenase injection (CI) that suggests similar outcomes in both treatments. Both treatments are minimally invasive, requiring minimal time off work and post-procedure pain. The main barrier to widespread adoption of CI is cost, particularly in patients with multiple areas of disease requiring treatment. The project proposed will compare these two methods for treating Dupuytren's disease.

Approximately 334 participants will be recruited from patients referred for treatment to hand surgeons trained in CI and PNA at two Calgary, AB hospitals. Need for treatment will be determined in the usual fashion, and the option for entry into the study will be proposed to patients meeting inclusion/exclusion criteria. Participants will be randomized into either the PNA or CI treatment group. The surgeon will not be blinded to the procedure group; however, the therapist measuring outcomes will be, and the study participants will need to not divulge to the therapists which group they are in.

Both procedures are performed under local freezing, and range from 5-20minutes. PNA involves the surgeon freezing the skin over the Dupuytren's cord, then using a small gauge needle inserted under the skin to cut the cord. This is repeated up the length of the cord to weaken it, allowing the surgeon to extend the finger and rupture the cord. CI involves the injection of collagenase (Xiaflex®), directly into the Dupuytren's cord. The patient then returns to see the surgeon within one week, has freezing placed in the hand, and the affected digit is extended to rupture the already weakened cord.

The patient will be required to present to the hand therapist team for measurements of joint angles before and after the assigned treatment is performed. In order to measure treatment efficacy, study participants will be required to return for measurements of treated joints every 6 months. Lastly, participants will need to inform the performing surgeon or therapist, at follow-up visits of any complications they experience.


Condition Intervention Phase
Dupuytren Contracture Dupuytren's Disease of Finger Procedure: Percutaneous Needle Aponeurotomy Drug: XIAFLEX Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Collagenase Injection and Percutaneous Needle Aponeurotomy for Treatment of Dupuytren's Disease

Resource links provided by NLM:


Further study details as provided by Justin Yeung, University of Calgary:

Primary Outcome Measures:
  • Contracture Recurrence [ Time Frame: 6 months - 5 years ]
    Recurrence defined by an increase in joint contracture of at least 30 degrees in presence of palpable cord, or the patient underwent repeat intervention to correct new/worsening contracture in the treated joint.


Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: Intervention to 5 years post-intervention ]
    Survey

  • Complications [ Time Frame: Intervention to 5 years post-intervention ]
    Patient to Report


Estimated Enrollment: 334
Study Start Date: January 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Percutaneous Needle Aponeurotomy
Percutaneous Needle Aponeurotomy (PNA) involves the surgeon anaesthetizing the skin over the Dupuytren's cord, then using a small gauge needle inserted percutaneously, cutting the cord with the sharp edge of the needle using a sweeping motion. This is repeated up the length of the cord to weaken it, allowing an extension force to be applied over the finger to rupture the cord.
Procedure: Percutaneous Needle Aponeurotomy
Other Name: Percutaneous Needle Fasciotomy
Active Comparator: Collagenase Injection
Collagenase Injection (CI) involves the injection of collagenase clostridium histolyticum (0.58 mg), directly into the Dupuytren's cord. The patient then returns to see the surgeon within one week, has local anaesthetic is administered, and an extension force is applied to the affected digit to rupture the already weakened cord.
Drug: XIAFLEX
Other Name: collagenase clostridium histolyticum

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring treatment for functionally limiting Dupuytren's disease involving the MCP and PIP joints, defined as MCP joint contracture 20-100 degrees, PIP joint contracture 20-80 degrees and positive table top test. Patients must be over 18 years of age to enroll in the study.

Exclusion Criteria:

  • Patients who have had previous interventions of contracture presenting for treatment, in an effort to compare similar disease state and risk with each procedure.
  • Disease involving DIP joint or thumb, as collagenase has not been approved for use in the thumb or DIP joints.
  • Pregnant or nursing, although there is data indicating no detection of collagenase in patient serum following injection for Dupuytren's contractures, there is no data exploring the effects of collagenase on a fetus or infant.
  • Anticoagulation therapy other than ASA (held 7 days prior to procedure), which is a recommendation by the manufacture of collagenase used in this study.
  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): NCT03000114


Contacts
Contact: Justin Yeung, MD 403-800-9157 Justin.Yeung2@albertahealthservices.ca
Contact: Valerie Hurdle, MD 4038161345 vhurdle@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Justin Yeung, MD    403-800-9157    Justin.Yeung2@albertahealthservices.ca   
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Justin Yeung, MD University of Calgary
  More Information

Publications:
Lermusiaux JL, Debeyre N. Le traitement médical de la maladie de Dupuytren. In: de Sèze S, Ryckewaert A, Kahn MF, Guérin CI. L'actualité rhumatologique 1979. Paris: Expansion Scientifique Française, 1980:338 -343.

Responsible Party: Justin Yeung, Doctor, University of Calgary
ClinicalTrials.gov Identifier: NCT03000114     History of Changes
Other Study ID Numbers: REB15-2463
First Submitted: December 17, 2016
First Posted: December 21, 2016
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Justin Yeung, University of Calgary:
Collagenase injection
percutaneous needle aponeurotomy

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