<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03000114</url>
  </required_header>
  <id_info>
    <org_study_id>REB15-2463</org_study_id>
    <nct_id>NCT03000114</nct_id>
  </id_info>
  <brief_title>Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease</brief_title>
  <official_title>Comparison of Collagenase Injection and Percutaneous Needle Aponeurotomy for Treatment of Dupuytren's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dupuytren's disease is a non-curative, progressive disorder leading to function-impairing&#xD;
      deformities of the hand. Although numerous treatments exist, the most common and widely&#xD;
      accepted therapy is removal of diseased fascia. Surgery is limited by prolonged recovery&#xD;
      time, and many patients require multiple surgeries throughout their life as the disease&#xD;
      progresses, with repeat surgeries increasing the risk of complications.&#xD;
&#xD;
      Long recovery times and need for repeat surgeries has renewed interest in minimally invasive&#xD;
      treatments for Dupuytren's disease. Percutaneous needle aponeurotomy (PNA) allows for rapid&#xD;
      improvement in finger extension with minimal recovery time. The FDA approved collagenase&#xD;
      clostridium histolyticum injection for Dupuytren's disease in 2010, which also allows for&#xD;
      rapid increase in finger extension, also with minimal recovery time. Currently there is only&#xD;
      one small study comparing PNA and collagenase injection (CI) that suggests similar outcomes&#xD;
      in both treatments. Both treatments are minimally invasive, requiring minimal time off work&#xD;
      and post-procedure pain. The main barrier to widespread adoption of CI is cost, particularly&#xD;
      in patients with multiple areas of disease requiring treatment. The project proposed will&#xD;
      compare these two methods for treating Dupuytren's disease.&#xD;
&#xD;
      Approximately 334 participants will be recruited from patients referred for treatment to hand&#xD;
      surgeons trained in CI and PNA at two Calgary, AB hospitals. Need for treatment will be&#xD;
      determined in the usual fashion, and the option for entry into the study will be proposed to&#xD;
      patients meeting inclusion/exclusion criteria. Participants will be randomized into either&#xD;
      the PNA or CI treatment group. The surgeon will not be blinded to the procedure group;&#xD;
      however, the therapist measuring outcomes will be, and the study participants will need to&#xD;
      not divulge to the therapists which group they are in.&#xD;
&#xD;
      Both procedures are performed under local freezing, and range from 5-20minutes. PNA involves&#xD;
      the surgeon freezing the skin over the Dupuytren's cord, then using a small gauge needle&#xD;
      inserted under the skin to cut the cord. This is repeated up the length of the cord to weaken&#xD;
      it, allowing the surgeon to extend the finger and rupture the cord. CI involves the injection&#xD;
      of collagenase (Xiaflex®), directly into the Dupuytren's cord. The patient then returns to&#xD;
      see the surgeon within one week, has freezing placed in the hand, and the affected digit is&#xD;
      extended to rupture the already weakened cord.&#xD;
&#xD;
      The patient will be required to present to the hand therapist team for measurements of joint&#xD;
      angles before and after the assigned treatment is performed. In order to measure treatment&#xD;
      efficacy, study participants will be required to return for measurements of treated joints&#xD;
      every 6 months. Lastly, participants will need to inform the performing surgeon or therapist,&#xD;
      at follow-up visits of any complications they experience.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Contracture Recurrence</measure>
    <time_frame>6 months - 5 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Intervention to 5 years post-intervention</time_frame>
    <description>Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Intervention to 5 years post-intervention</time_frame>
    <description>Patient to Report</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">334</enrollment>
  <condition>Dupuytren Contracture</condition>
  <condition>Dupuytren's Disease of Finger</condition>
  <arm_group>
    <arm_group_label>Percutaneous Needle Aponeurotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collagenase Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Needle Aponeurotomy</intervention_name>
    <arm_group_label>Percutaneous Needle Aponeurotomy</arm_group_label>
    <other_name>Percutaneous Needle Fasciotomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XIAFLEX</intervention_name>
    <arm_group_label>Collagenase Injection</arm_group_label>
    <other_name>collagenase clostridium histolyticum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients requiring treatment for functionally limiting Dupuytren's disease involving&#xD;
             the MCP and PIP joints, defined as MCP joint contracture 20-100 degrees, PIP joint&#xD;
             contracture 20-80 degrees and positive table top test. Patients must be over 18 years&#xD;
             of age to enroll in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had previous interventions of contracture presenting for treatment,&#xD;
             in an effort to compare similar disease state and risk with each procedure.&#xD;
&#xD;
          -  Disease involving DIP joint or thumb, as collagenase has not been approved for use in&#xD;
             the thumb or DIP joints.&#xD;
&#xD;
          -  Pregnant or nursing, although there is data indicating no detection of collagenase in&#xD;
             patient serum following injection for Dupuytren's contractures, there is no data&#xD;
             exploring the effects of collagenase on a fetus or infant.&#xD;
&#xD;
          -  Anticoagulation therapy other than ASA (held 7 days prior to procedure), which is a&#xD;
             recommendation by the manufacture of collagenase used in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Justin Yeung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Justin Yeung, MD</last_name>
    <phone>403-800-9157</phone>
    <email>Justin.Yeung2@albertahealthservices.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Valerie Hurdle, MD</last_name>
    <phone>4038161345</phone>
    <email>vhurdle@ucalgary.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin Yeung, MD</last_name>
      <phone>403-800-9157</phone>
      <email>Justin.Yeung2@albertahealthservices.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011 May;36(5):936-42. doi: 10.1016/j.jhsa.2011.03.002.</citation>
    <PMID>21527148</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.</citation>
    <PMID>19726771</PMID>
  </reference>
  <reference>
    <citation>Gilpin D, Coleman S, Hall S, Houston A, Karrasch J, Jones N. Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren's disease. J Hand Surg Am. 2010 Dec;35(12):2027-38.e1. doi: 10.1016/j.jhsa.2010.08.007.</citation>
    <PMID>21134613</PMID>
  </reference>
  <reference>
    <citation>Nydick JA, Olliff BW, Garcia MJ, Hess AV, Stone JD. A comparison of percutaneous needle fasciotomy and collagenase injection for dupuytren disease. J Hand Surg Am. 2013 Dec;38(12):2377-80. doi: 10.1016/j.jhsa.2013.08.096. Epub 2013 Sep 20.</citation>
    <PMID>24060510</PMID>
  </reference>
  <reference>
    <citation>Chen NC, Shauver MJ, Chung KC. Cost-effectiveness of open partial fasciectomy, needle aponeurotomy, and collagenase injection for dupuytren contracture. J Hand Surg Am. 2011 Nov;36(11):1826-1834.e32. doi: 10.1016/j.jhsa.2011.08.004. Epub 2011 Oct 5.</citation>
    <PMID>21981831</PMID>
  </reference>
  <reference>
    <citation>Smith AC. Diagnosis and indications for surgical treatment. Hand Clin. 1991 Nov;7(4):635-42; discussion 643.</citation>
    <PMID>1769986</PMID>
  </reference>
  <reference>
    <citation>Peimer CA, Blazar P, Coleman S, Kaplan FT, Smith T, Lindau T. Dupuytren Contracture Recurrence Following Treatment With Collagenase Clostridium histolyticum (CORDLESS [Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study]): 5-Year Data. J Hand Surg Am. 2015 Aug;40(8):1597-605. doi: 10.1016/j.jhsa.2015.04.036. Epub 2015 Jun 18.</citation>
    <PMID>26096221</PMID>
  </reference>
  <reference>
    <citation>van Rijssen AL, Werker PM. Percutaneous needle fasciotomy in dupuytren's disease. J Hand Surg Br. 2006 Oct;31(5):498-501. doi: 10.1016/j.jhsb.2006.03.174. Epub 2006 Jun 12.</citation>
    <PMID>16766101</PMID>
  </reference>
  <reference>
    <citation>Zhang AY, Curtin CM, Hentz VR. Flexor tendon rupture after collagenase injection for Dupuytren contracture: case report. J Hand Surg Am. 2011 Aug;36(8):1323-5. doi: 10.1016/j.jhsa.2011.05.016. Epub 2011 Jun 25.</citation>
    <PMID>21705158</PMID>
  </reference>
  <reference>
    <citation>van Rijssen AL, Ter Linden H, Werker PMN. Five-year results of a randomized clinical trial on treatment in Dupuytren's disease: percutaneous needle fasciotomy versus limited fasciectomy. Plast Reconstr Surg. 2012 Feb;129(2):469-477. doi: 10.1097/PRS.0b013e31823aea95.</citation>
    <PMID>21987045</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Justin Yeung</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Collagenase injection</keyword>
  <keyword>percutaneous needle aponeurotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dupuytren Contracture</mesh_term>
    <mesh_term>Contracture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000114
org study id: REB15-2463
nct id: NCT03000114
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Contracture Recurrence
time frame: 6 months - 5 years
description: 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.
measure: Patient Satisfaction
time frame: Intervention to 5 years post-intervention
description: Survey
measure: Complications
time frame: Intervention to 5 years post-intervention
description: Patient to Report
arm group label: Percutaneous Needle Aponeurotomy
arm group type: Active Comparator
description: 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.
arm group label: Collagenase Injection
arm group type: Active Comparator
description: 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.
intervention type: Procedure
intervention name: Percutaneous Needle Aponeurotomy
arm group label: Percutaneous Needle Aponeurotomy
other name: Percutaneous Needle Fasciotomy
intervention type: Drug
intervention name: XIAFLEX
arm group label: Collagenase Injection
other name: collagenase clostridium histolyticum
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Justin Yeung, MD
role: Principal Investigator
affiliation: University of Calgary
last name: Justin Yeung, MD
phone: 403-800-9157
email: Justin.Yeung2@albertahealthservices.ca
last name: Valerie Hurdle, MD
phone: 4038161345
email: vhurdle@ucalgary.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011 May;36(5):936-42. doi: 10.1016/j.jhsa.2011.03.002.
PMID: 21527148
citation: 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.
citation: Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.
PMID: 19726771
citation: Gilpin D, Coleman S, Hall S, Houston A, Karrasch J, Jones N. Injectable collagenase Clostridium histolyticum: a new nonsurgical treatment for Dupuytren's disease. J Hand Surg Am. 2010 Dec;35(12):2027-38.e1. doi: 10.1016/j.jhsa.2010.08.007.
PMID: 21134613
citation: Nydick JA, Olliff BW, Garcia MJ, Hess AV, Stone JD. A comparison of percutaneous needle fasciotomy and collagenase injection for dupuytren disease. J Hand Surg Am. 2013 Dec;38(12):2377-80. doi: 10.1016/j.jhsa.2013.08.096. Epub 2013 Sep 20.
PMID: 24060510
citation: Chen NC, Shauver MJ, Chung KC. Cost-effectiveness of open partial fasciectomy, needle aponeurotomy, and collagenase injection for dupuytren contracture. J Hand Surg Am. 2011 Nov;36(11):1826-1834.e32. doi: 10.1016/j.jhsa.2011.08.004. Epub 2011 Oct 5.
PMID: 21981831
citation: Smith AC. Diagnosis and indications for surgical treatment. Hand Clin. 1991 Nov;7(4):635-42; discussion 643.
PMID: 1769986
citation: Peimer CA, Blazar P, Coleman S, Kaplan FT, Smith T, Lindau T. Dupuytren Contracture Recurrence Following Treatment With Collagenase Clostridium histolyticum (CORDLESS [Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study]): 5-Year Data. J Hand Surg Am. 2015 Aug;40(8):1597-605. doi: 10.1016/j.jhsa.2015.04.036. Epub 2015 Jun 18.
PMID: 26096221
citation: van Rijssen AL, Werker PM. Percutaneous needle fasciotomy in dupuytren's disease. J Hand Surg Br. 2006 Oct;31(5):498-501. doi: 10.1016/j.jhsb.2006.03.174. Epub 2006 Jun 12.
PMID: 16766101
citation: Zhang AY, Curtin CM, Hentz VR. Flexor tendon rupture after collagenase injection for Dupuytren contracture: case report. J Hand Surg Am. 2011 Aug;36(8):1323-5. doi: 10.1016/j.jhsa.2011.05.016. Epub 2011 Jun 25.
PMID: 21705158
citation: van Rijssen AL, Ter Linden H, Werker PMN. Five-year results of a randomized clinical trial on treatment in Dupuytren's disease: percutaneous needle fasciotomy versus limited fasciectomy. Plast Reconstr Surg. 2012 Feb;129(2):469-477. doi: 10.1097/PRS.0b013e31823aea95.
PMID: 21987045
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Justin Yeung
investigator title: Doctor
mesh term: Dupuytren Contracture
mesh term: Contracture
sharing ipd: Undecided