<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/NCT04403919</url>
  </required_header>
  <id_info>
    <org_study_id>20-00280</org_study_id>
    <nct_id>NCT04403919</nct_id>
  </id_info>
  <brief_title>Knotless Suture in Revision Total Joint Arthroplasty</brief_title>
  <official_title>Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Barbed suture has been demonstrated to be safe in primary hip and knee surgery and&#xD;
      retrospective data suggests barbed suture represents no increased complications in the&#xD;
      revision setting. Barbed suture may represent a faster, more effective way to perform&#xD;
      revision arthroplasty closures. There are no Level I studies comparing traditional and barbed&#xD;
      suture closure. The purpose of this study is to assess the surgical complexities of closures&#xD;
      using closure time without sacrificing cosmesis or wound complications between the&#xD;
      traditional closure and barbed closure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">June 1, 2023</completion_date>
  <primary_completion_date type="Actual">June 1, 2023</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>prospective, randomized, controlled trial, parallel four-arm design, single-center study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time of closure in seconds</measure>
    <time_frame>30 minutes (perioperative)</time_frame>
    <description>Measurement of the time needed to properly close the wound with each technique.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Complications Related to Wound Closure</measure>
    <time_frame>Day 90</time_frame>
    <description>Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Cost of Assigned Closure Procedure</measure>
    <time_frame>Day 90</time_frame>
    <description>Assessment of the cost difference based on supplies, personnel, and time between each technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (POSAS) Score</measure>
    <time_frame>Week 6 Post-Surgery</time_frame>
    <description>The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale, where 0 = normal skin and 10 = worst scar imaginable. Together they make up the 'Total Score' of the Patient and Observer Scale, which ranges from 0 to 120; higher scores indicate worse scars.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Sutures Used</measure>
    <time_frame>30 minutes (perioperative)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Incision</measure>
    <time_frame>30 minutes (perioperative)</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Revision total knee arthroplasty: control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Revision total knee arthroplasty: active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Revision Total Hip Arthroplasty: control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Revision Total Hip Arthroplasty: active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Closure: Knee</intervention_name>
    <description>Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson &amp; Johnson) and Dermabond advanced.</description>
    <arm_group_label>Revision total knee arthroplasty: control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Barbed suture closure: Knee</intervention_name>
    <description>The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.</description>
    <arm_group_label>Revision total knee arthroplasty: active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Closure: Hip</intervention_name>
    <description>The capsule will be closed with Vicryl Plus number 1&#xD;
Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &amp;Johnson, Somerville, NJ)&#xD;
Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus)&#xD;
Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson &amp; Johnson)&#xD;
followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &amp;Johnson).</description>
    <arm_group_label>Revision Total Hip Arthroplasty: control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Barbed suture closure: Hip</intervention_name>
    <description>The capsule will be closed with stratafix symmetric PDS Plus&#xD;
Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &amp;Johnson, Somerville, NJ)&#xD;
Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson &amp; Johnson, Somerville, NJ)&#xD;
Subcuticular suture with stratafix spiral monocryl plus, Ethicon&#xD;
followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &amp;Johnson).</description>
    <arm_group_label>Revision Total Hip Arthroplasty: active</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients ≥ 18 years of age&#xD;
&#xD;
          2. Surgical candidates undergoing revision total knee or total hip arthroplasty for one&#xD;
             of the following indications second stage of two stage reimplantation for infection,&#xD;
             mechanical loosening, instability, polyethylene wear, stiffness, or periprosthetic&#xD;
             fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is ≤ 18 years of age&#xD;
&#xD;
          2. Patient is unable to provide written consent&#xD;
&#xD;
          3. Patient has active infections in the operative leg/joint&#xD;
&#xD;
          4. Known Allergy to Suture material&#xD;
&#xD;
          5. Underlying Dermatological diseases affecting surgical site including dermatitis,&#xD;
             eczema, or psoriasis; connective tissue or vascular disorders or diseases that would&#xD;
             adversely affect wound healing; metastatic cancer; renal insufficiency (dialysis);&#xD;
             steroid dependence; malnourishment; and other disease processes resulting in an&#xD;
             immunocompromised state. Diabetes, smoking and obesity will be allowed as they are&#xD;
             frequent comorbidities in our revision joint population&#xD;
&#xD;
          6. Anterior total hip replacement&#xD;
&#xD;
          7. Stage 1 of two stage revision for infection&#xD;
&#xD;
          8. Closure performed by plastic surgeon, including flap coverage&#xD;
&#xD;
        Vulnerable populations will not be enrolled in this study.&#xD;
&#xD;
        Withdrawal Criteria&#xD;
&#xD;
          1. Failure to attend regularly scheduled follow up appointments&#xD;
&#xD;
          2. Deviation from closure protocol&#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>Ran Schwarzkopf, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>Requests should be directed to ran.schwarzkopf@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT04403919
org study id: 20-00280
nct id: NCT04403919
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Barbed suture has been demonstrated to be safe in primary hip and knee surgery and
      retrospective data suggests barbed suture represents no increased complications in the
      revision setting. Barbed suture may represent a faster, more effective way to perform
      revision arthroplasty closures. There are no Level I studies comparing traditional and barbed
      suture closure. The purpose of this study is to assess the surgical complexities of closures
      using closure time without sacrificing cosmesis or wound complications between the
      traditional closure and barbed closure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized, controlled trial, parallel four-arm design, single-center study
primary purpose: Other
masking: None (Open Label)
measure: Time of closure in seconds
time frame: 30 minutes (perioperative)
description: Measurement of the time needed to properly close the wound with each technique.
measure: Incidence of Complications Related to Wound Closure
time frame: Day 90
description: Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure.
measure: Total Cost of Assigned Closure Procedure
time frame: Day 90
description: Assessment of the cost difference based on supplies, personnel, and time between each technique.
measure: Patient and Observer Scar Assessment Scale (POSAS) Score
time frame: Week 6 Post-Surgery
description: The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale, where 0 = normal skin and 10 = worst scar imaginable. Together they make up the 'Total Score' of the Patient and Observer Scale, which ranges from 0 to 120; higher scores indicate worse scars.
measure: Total Number of Sutures Used
time frame: 30 minutes (perioperative)
measure: Length of Incision
time frame: 30 minutes (perioperative)
arm group label: Revision total knee arthroplasty: control
arm group type: Active Comparator
arm group label: Revision total knee arthroplasty: active
arm group type: Experimental
arm group label: Revision Total Hip Arthroplasty: control
arm group type: Active Comparator
arm group label: Revision Total Hip Arthroplasty: active
arm group type: Experimental
intervention type: Device
intervention name: Conventional Closure: Knee
description: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson & Johnson) and Dermabond advanced.
arm group label: Revision total knee arthroplasty: control
intervention type: Device
intervention name: Barbed suture closure: Knee
description: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
arm group label: Revision total knee arthroplasty: active
intervention type: Device
intervention name: Conventional Closure: Hip
description: The capsule will be closed with Vicryl Plus number 1
Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &Johnson, Somerville, NJ)
Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus)
Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson)
followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson).
arm group label: Revision Total Hip Arthroplasty: control
intervention type: Device
intervention name: Barbed suture closure: Hip
description: The capsule will be closed with stratafix symmetric PDS Plus
Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &Johnson, Somerville, NJ)
Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson & Johnson, Somerville, NJ)
Subcuticular suture with stratafix spiral monocryl plus, Ethicon
followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson).
arm group label: Revision Total Hip Arthroplasty: active
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ran Schwarzkopf, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: Requests should be directed to ran.schwarzkopf@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.