<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/NCT04403958</url>
  </required_header>
  <id_info>
    <org_study_id>1467/2020</org_study_id>
    <nct_id>NCT04403958</nct_id>
  </id_info>
  <brief_title>The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion</brief_title>
  <acronym>PROOF II</acronym>
  <official_title>The Use of Proximal Carpal Row Versus Iliac Crest Bone Graft in Total Wrist Fusion - a Randomized Controlled Multicenter Trial Comparing Two Operative Techniques (PROOF II - Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Töölö Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kymenlaakso Central Hospital Kotka Finland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Töölö Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal&#xD;
      carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone&#xD;
      graft.&#xD;
&#xD;
      Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized&#xD;
      (1:1 computer generated sequence with random block size) to two parallel groups and will&#xD;
      undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting.&#xD;
&#xD;
      Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after&#xD;
      the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the&#xD;
      primary outcome is fusion rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fusion rate (percent)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain (Visual Analogue Scale)</measure>
    <time_frame>6 months</time_frame>
    <description>The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Rated Wrist Evaluation (PRWE)</measure>
    <time_frame>6 months</time_frame>
    <description>The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)</measure>
    <time_frame>6 months</time_frame>
    <description>The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Global rating to treatment effect will be evaluated by question: &quot;How would you rate the function of your hand compared to the situation before the treatment?&quot;. The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>6 months</time_frame>
    <description>Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>Perioperative</time_frame>
    <description>Operative time is measured in minutes for time in the operation theatre and time used for surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence of complications (i.e. non-union, fracture, re-operation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Wrist Arthritis</condition>
  <condition>Fusion; Joint</condition>
  <arm_group>
    <arm_group_label>PRC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total wrist arthrodesis with PRC and dorsal plate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TWA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total wrist arthrodesis with dorsal plate</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PRC</intervention_name>
    <description>Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft</description>
    <arm_group_label>PRC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TWA</intervention_name>
    <description>Total wrist arthrodesis with dorsal plate using iliac crest as bone graft</description>
    <arm_group_label>TWA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 - 75&#xD;
&#xD;
          -  Symptom duration &gt; 3 months&#xD;
&#xD;
          -  American Society of Anaesthesiologists physical status (ASA) I-III&#xD;
&#xD;
          -  Fluent in written and spoken Finnish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 or &gt;75 years&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Heavy smoking (&gt; 20 cigarettes per day)&#xD;
&#xD;
          -  Condition or medication affecting bony healing (eg diabetes mellitus with poor&#xD;
             glycemic control, malnutrition, use of per oral corticosteroids)&#xD;
&#xD;
          -  Ulnar variance &gt; 1 mm&#xD;
&#xD;
          -  Wrist pain treatable with partial wrist fusion&#xD;
&#xD;
          -  Previous partial wrist fusion&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  Neurological condition affecting upper limb function&#xD;
&#xD;
          -  Less than 6 months after another operation of the same upper limb&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuli Aspinen, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>HUS Töölö Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samuli Aspinen, M.D., Ph.D.</last_name>
    <phone>+358406360546</phone>
    <email>samuli.aspinen@hus.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jorma Ryhänen, adj. prof.</last_name>
    <email>jorma.ryhanen@hus.fi</email>
  </overall_contact_backup>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Töölö Hospital</investigator_affiliation>
    <investigator_full_name>Samuli Aspinen</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Ankylosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04403958
org study id: 1467/2020
nct id: NCT04403958
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal
      carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone
      graft.

      Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized
      (1:1 computer generated sequence with random block size) to two parallel groups and will
      undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting.

      Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after
      the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the
      primary outcome is fusion rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fusion rate (percent)
time frame: 6 months
measure: Pain (Visual Analogue Scale)
time frame: 6 months
description: The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)
measure: Patient-Rated Wrist Evaluation (PRWE)
time frame: 6 months
description: The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
measure: Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)
time frame: 6 months
description: The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)
measure: Global improvement
time frame: 6 months
description: Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better
measure: Grip strength
time frame: 6 months
description: Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side
measure: Operative time
time frame: Perioperative
description: Operative time is measured in minutes for time in the operation theatre and time used for surgery
measure: Complications
time frame: 12 months
description: Incidence of complications (i.e. non-union, fracture, re-operation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.
arm group label: PRC
arm group type: Experimental
description: Total wrist arthrodesis with PRC and dorsal plate
arm group label: TWA
arm group type: Active Comparator
description: Total wrist arthrodesis with dorsal plate
intervention type: Procedure
intervention name: PRC
description: Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
arm group label: PRC
intervention type: Procedure
intervention name: TWA
description: Total wrist arthrodesis with dorsal plate using iliac crest as bone graft
arm group label: TWA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Samuli Aspinen, M.D., Ph.D.
role: Principal Investigator
affiliation: HUS Töölö Hospital
last name: Samuli Aspinen, M.D., Ph.D.
phone: +358406360546
email: samuli.aspinen@hus.fi
last name: Jorma Ryhänen, adj. prof.
email: jorma.ryhanen@hus.fi
responsible party type: Principal Investigator
investigator affiliation: Töölö Hospital
investigator full name: Samuli Aspinen
investigator title: Principal investigator
mesh term: Arthritis
mesh term: Ankylosis
sharing ipd: No