<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/NCT04505020</url>
  </required_header>
  <id_info>
    <org_study_id>3DPRINT</org_study_id>
    <nct_id>NCT04505020</nct_id>
  </id_info>
  <brief_title>The Innovation of 3D Printing for Preoperative Planning in Hip Preservation Surgery</brief_title>
  <official_title>The Innovation of 3D Printing for Preoperative Planning in Hip Preservation Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</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>
      This is a randomized controlled trial (RCT) to evaluate the introduction of a 3D printed&#xD;
      model into the pre and intra-operative planning for arthroscopic femoroacetabular impingement&#xD;
      (FAI) surgery. The RCT will look to place patients into one of two treatment groups: 1)&#xD;
      conventional preoperative imaging (X-ray, CT, and MRI) only and 2) those that have had a 3D&#xD;
      printed model created in addition to the conventional imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, we investigate the use of 3D models during pre and intra-operative planning&#xD;
      could improve the success of hip arthroscopy and reduce the incidence of revision cases. By&#xD;
      adding an adjunct to the common suite of pre-operative imaging modalities (X-ray, MRI and&#xD;
      CT), we can change the surgeon's understanding of each patient's individual morphology with a&#xD;
      tactile physical model. This study will compare the success of hip arthroscopy in patients&#xD;
      with or without 3D printed models (in addition to traditional pre-operative imaging).&#xD;
&#xD;
      This will be a single-center, blinded observer, randomized controlled trial of 80 patients&#xD;
      performed at the Halifax Infirmary, Queen Elizabeth II Health Sciences Center in Halifax,&#xD;
      Nova Scotia. Patients with cam-type FAI involved in the study will be approached by the&#xD;
      surgeon, Dr. Ivan Wong, or a delegate regarding the study during a pre-operative visit.&#xD;
      Following a detailed discussion of the risks/benefits/alternatives of this study, the patient&#xD;
      will be provided with a copy of the informed consent to review, if they demonstrate an&#xD;
      interest in the study. If the patient wishes to be enrolled in the study, the research team&#xD;
      will obtain patient consent for the study according to the Division of Orthopaedic Surgery&#xD;
      and Nova Scotia Health Authority (NSHA) institutional protocols.&#xD;
&#xD;
      In the pre-operative period, there will be no additional time requirements for the&#xD;
      participant, except for the informed consent process for the study. Routine X-ray&#xD;
      radiographs, as well as a pre-operative MRI and CT scan, will be obtained for all subjects&#xD;
      undergoing FAI surgery. The participants will not be exposed to any additional radiation.&#xD;
      Subjects will complete a structured clinical examination conducted by a sports medicine&#xD;
      fellowship-trained orthopaedic consultant. The patient will also complete pre-operative&#xD;
      questionnaires.&#xD;
&#xD;
      Patients that have consented to the study will be randomized into two groups with a 50%&#xD;
      chance of being in either group. Randomization will be done with a computer random number&#xD;
      generator. Both groups will undergo routine pre-operative imaging but one group will also&#xD;
      have a 3D print made from the 3D CT reconstruction. All patient groups will undergo hip&#xD;
      arthroscopy for the treatment of their FAI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</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>Patients that have consented to the study will be randomized into four groups with a 50% chance of being in either group. The two treatment groups are 1) conventional preoperative imaging (X-ray, CT, and MRI) only 2) those that have had a 3D printed model created in addition to conventional imaging. There will be 40 patients in each group. Randomization will be done with a computer random number generator. Both groups will undergo routine pre-operative imaging but one group will also have a 3D print made from the 3D CT reconstruction. Both patient groups will undergo hip arthroscopy for treatment of their FAI.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants will be blinded/masked to the treatment (if they do or don't receive a 3D printed model of their hip) they receive until the end of the study. Patients will still be aware of the details of their surgical treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of CAM resection</measure>
    <time_frame>Change in Pre-op measurements compared to 2 weeks post-operatively</time_frame>
    <description>Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of CAM resection</measure>
    <time_frame>Change in Pre-op measurements compared to 6 months post-operatively</time_frame>
    <description>Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure of CAM resection</measure>
    <time_frame>Change in Pre-op measurements compared to 24 months post-operatively</time_frame>
    <description>Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in post-operative patient reported outcomes: iHOT-33</measure>
    <time_frame>Change in outcomes 24 months post operatively compared to Pre-operatively</time_frame>
    <description>The secondary outcome is the differences in post-operative patient reported outcomes for the international hip outcome tool (iHOT-33) when compared to a pre-operative baseline. (Scores for the International hip outcome tool range from 0-100 where higher values represent better outcomes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in post-operative patient reported outcomes: NAHS</measure>
    <time_frame>Change in outcomes 24 months post operatively compared to Pre-operatively</time_frame>
    <description>The secondary outcome is the differences in post-operative patient reported outcomes for the Non-arthritic Hip Score (NAHS) when compared to a pre-operative baseline. (Scores for the Non-arthritic Hip Score range from 0-80 where higher values represent better outcomes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in post-operative patient reported outcomes: EQ5D</measure>
    <time_frame>Change in outcomes 24 months post operatively compared to Pre-operatively</time_frame>
    <description>The secondary outcome is the differences in post-operative patient reported outcomes for the European Quality of Life Questionnaire (EQ-5D) when compared to a pre-operative baseline. (Scores for EQ-5D range from 1-5 in 5 categories where lower values represent better outcomes in each category).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in post-operative patient reported outcomes: EQ5D-VAS</measure>
    <time_frame>Change in outcomes 24 months post operatively compared to Pre-operatively</time_frame>
    <description>The secondary outcome is the differences in post-operative patient reported outcomes for the European Quality of Life Questionnaire-Visual Analog Scale (EQ-5D-VAS) when compared to a pre-operative baseline. (Scores for EQ-5D-VAS range from 0-100 where higher values represent better outcomes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in post-operative patient reported outcomes: VR-12</measure>
    <time_frame>Change in outcomes 24 months post operatively compared to Pre-operatively</time_frame>
    <description>The secondary outcome is the differences in post-operative patient reported outcomes for the Veteran's RAND 12 Item Health Survey (VR-12) when compared to a pre-operative baseline. (Scores for VR-12 range from 0-100 where higher values represent better outcomes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in post-operative patient reported outcomes: HOS-Usual Activities</measure>
    <time_frame>Change in outcomes 24 months post operatively compared to Pre-operatively</time_frame>
    <description>The secondary outcome is the differences in post-operative patient reported outcomes for the Hip Outcome Score for usual activities (HOS-UA) when compared to a pre-operative baseline. (Scores for HOS range from 0-68 where higher values represent better outcomes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in post-operative patient reported outcomes: HOS-Sport</measure>
    <time_frame>Change in outcomes 24 months post operatively compared to Pre-operatively</time_frame>
    <description>The secondary outcome is the differences in post-operative patient reported outcomes for the Hip Outcome Score for sports (HOS-S) when compared to a pre-operative baseline. (Scores for HOS range from 0-30 where higher values represent better outcomes).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The number of times conventional imaging and 3D prints are referenced intra-operatively.</measure>
    <time_frame>During surgery only</time_frame>
    <description>Another secondary outcome is the number of times each of the following are referenced intra-operatively: X-Rays, MRI, MRA, CT, CT with 3D reconstruction and 3D model of patient's hip. Additionally the number of X-Ray images taken intra-operatively will be recorded.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Femoro Acetabular Impingement</condition>
  <arm_group>
    <arm_group_label>3D Print + Conventional imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group allocation will receive a 3D reconstruction of their hip in addition to conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Imaging</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in this group allocation will receive conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3D Print + Conventional imaging</intervention_name>
    <description>This group will have a 3D reconstruction of their hip printed using a 3D printer so that the PI can use it in their pre and intra-operative planning along with traditional imaging.</description>
    <arm_group_label>3D Print + Conventional imaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional imaging</intervention_name>
    <description>This group will have CT, MRI and X-Ray imaging completed so that the PI can use it in their pre and intra-operative planning.</description>
    <arm_group_label>Conventional Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Radiological proven diagnosis of cam-type femoroacetabular impingement (FAI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with advanced arthritis (Tonnis Grade III or Kellgren-Lawrence Grade III or&#xD;
             IV or evidence of less than 2 mm of joint space, as determined by conventional&#xD;
             radiographs.)&#xD;
&#xD;
          -  Patients with 1cm2 (or greater) of cartilage delamination in the hip&#xD;
&#xD;
          -  Patients with type III or IV heterotopic ossification&#xD;
&#xD;
          -  Patients with avascular necrosis&#xD;
&#xD;
          -  Patients who are unable to provide informed consent&#xD;
&#xD;
          -  Patients who are undergoing revision hip arthroscopy&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
&#xD;
          -  Patients who have the presence of local or systemic infection&#xD;
&#xD;
          -  Patients with an inability to cooperate with and/or comprehend post-operative&#xD;
             instructions&#xD;
&#xD;
          -  Patients with nonvascular surgical sites (MRI proven)&#xD;
&#xD;
          -  Patients with cancer&#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>Ivan Wong, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nova Scotia Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>5955 Veterans' Memorial Lane Room 2106, VMB</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>April 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Ivan Wong</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Femoroacetabular Impingement</keyword>
  <keyword>Cam lesion</keyword>
  <keyword>3D printing</keyword>
  <keyword>Pre-operative planning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoracetabular Impingement</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared with other researchers.</ipd_description>
  </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/NCT04505020
org study id: 3DPRINT
nct id: NCT04505020
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled trial (RCT) to evaluate the introduction of a 3D printed
      model into the pre and intra-operative planning for arthroscopic femoroacetabular impingement
      (FAI) surgery. The RCT will look to place patients into one of two treatment groups: 1)
      conventional preoperative imaging (X-ray, CT, and MRI) only and 2) those that have had a 3D
      printed model created in addition to the conventional imaging.
In this study, we investigate the use of 3D models during pre and intra-operative planning
      could improve the success of hip arthroscopy and reduce the incidence of revision cases. By
      adding an adjunct to the common suite of pre-operative imaging modalities (X-ray, MRI and
      CT), we can change the surgeon's understanding of each patient's individual morphology with a
      tactile physical model. This study will compare the success of hip arthroscopy in patients
      with or without 3D printed models (in addition to traditional pre-operative imaging).

      This will be a single-center, blinded observer, randomized controlled trial of 80 patients
      performed at the Halifax Infirmary, Queen Elizabeth II Health Sciences Center in Halifax,
      Nova Scotia. Patients with cam-type FAI involved in the study will be approached by the
      surgeon, Dr. Ivan Wong, or a delegate regarding the study during a pre-operative visit.
      Following a detailed discussion of the risks/benefits/alternatives of this study, the patient
      will be provided with a copy of the informed consent to review, if they demonstrate an
      interest in the study. If the patient wishes to be enrolled in the study, the research team
      will obtain patient consent for the study according to the Division of Orthopaedic Surgery
      and Nova Scotia Health Authority (NSHA) institutional protocols.

      In the pre-operative period, there will be no additional time requirements for the
      participant, except for the informed consent process for the study. Routine X-ray
      radiographs, as well as a pre-operative MRI and CT scan, will be obtained for all subjects
      undergoing FAI surgery. The participants will not be exposed to any additional radiation.
      Subjects will complete a structured clinical examination conducted by a sports medicine
      fellowship-trained orthopaedic consultant. The patient will also complete pre-operative
      questionnaires.

      Patients that have consented to the study will be randomized into two groups with a 50%
      chance of being in either group. Randomization will be done with a computer random number
      generator. Both groups will undergo routine pre-operative imaging but one group will also
      have a 3D print made from the 3D CT reconstruction. All patient groups will undergo hip
      arthroscopy for the treatment of their FAI.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients that have consented to the study will be randomized into four groups with a 50% chance of being in either group. The two treatment groups are 1) conventional preoperative imaging (X-ray, CT, and MRI) only 2) those that have had a 3D printed model created in addition to conventional imaging. There will be 40 patients in each group. Randomization will be done with a computer random number generator. Both groups will undergo routine pre-operative imaging but one group will also have a 3D print made from the 3D CT reconstruction. Both patient groups will undergo hip arthroscopy for treatment of their FAI.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participants will be blinded/masked to the treatment (if they do or don't receive a 3D printed model of their hip) they receive until the end of the study. Patients will still be aware of the details of their surgical treatment.
measure: Measure of CAM resection
time frame: Change in Pre-op measurements compared to 2 weeks post-operatively
description: Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
measure: Measure of CAM resection
time frame: Change in Pre-op measurements compared to 6 months post-operatively
description: Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
measure: Measure of CAM resection
time frame: Change in Pre-op measurements compared to 24 months post-operatively
description: Our primary outcome for this study is the resection of cam impingement according to alpha-angle on post-operative anterior-posterior (AP) and frog leg X-ray views.
measure: Differences in post-operative patient reported outcomes: iHOT-33
time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
description: The secondary outcome is the differences in post-operative patient reported outcomes for the international hip outcome tool (iHOT-33) when compared to a pre-operative baseline. (Scores for the International hip outcome tool range from 0-100 where higher values represent better outcomes)
measure: Differences in post-operative patient reported outcomes: NAHS
time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
description: The secondary outcome is the differences in post-operative patient reported outcomes for the Non-arthritic Hip Score (NAHS) when compared to a pre-operative baseline. (Scores for the Non-arthritic Hip Score range from 0-80 where higher values represent better outcomes).
measure: Differences in post-operative patient reported outcomes: EQ5D
time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
description: The secondary outcome is the differences in post-operative patient reported outcomes for the European Quality of Life Questionnaire (EQ-5D) when compared to a pre-operative baseline. (Scores for EQ-5D range from 1-5 in 5 categories where lower values represent better outcomes in each category).
measure: Differences in post-operative patient reported outcomes: EQ5D-VAS
time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
description: The secondary outcome is the differences in post-operative patient reported outcomes for the European Quality of Life Questionnaire-Visual Analog Scale (EQ-5D-VAS) when compared to a pre-operative baseline. (Scores for EQ-5D-VAS range from 0-100 where higher values represent better outcomes).
measure: Differences in post-operative patient reported outcomes: VR-12
time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
description: The secondary outcome is the differences in post-operative patient reported outcomes for the Veteran's RAND 12 Item Health Survey (VR-12) when compared to a pre-operative baseline. (Scores for VR-12 range from 0-100 where higher values represent better outcomes).
measure: Differences in post-operative patient reported outcomes: HOS-Usual Activities
time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
description: The secondary outcome is the differences in post-operative patient reported outcomes for the Hip Outcome Score for usual activities (HOS-UA) when compared to a pre-operative baseline. (Scores for HOS range from 0-68 where higher values represent better outcomes).
measure: Differences in post-operative patient reported outcomes: HOS-Sport
time frame: Change in outcomes 24 months post operatively compared to Pre-operatively
description: The secondary outcome is the differences in post-operative patient reported outcomes for the Hip Outcome Score for sports (HOS-S) when compared to a pre-operative baseline. (Scores for HOS range from 0-30 where higher values represent better outcomes).
measure: The number of times conventional imaging and 3D prints are referenced intra-operatively.
time frame: During surgery only
description: Another secondary outcome is the number of times each of the following are referenced intra-operatively: X-Rays, MRI, MRA, CT, CT with 3D reconstruction and 3D model of patient's hip. Additionally the number of X-Ray images taken intra-operatively will be recorded.
arm group label: 3D Print + Conventional imaging
arm group type: Experimental
description: Patients in this group allocation will receive a 3D reconstruction of their hip in addition to conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure.
arm group label: Conventional Imaging
arm group type: Other
description: Patients in this group allocation will receive conventional preoperative imaging (X-ray, CT, and MRI) only for the use of pre-operative and intra-operative planning for their hip arthroscopy (FAI) procedure.
intervention type: Other
intervention name: 3D Print + Conventional imaging
description: This group will have a 3D reconstruction of their hip printed using a 3D printer so that the PI can use it in their pre and intra-operative planning along with traditional imaging.
arm group label: 3D Print + Conventional imaging
intervention type: Other
intervention name: Conventional imaging
description: This group will have CT, MRI and X-Ray imaging completed so that the PI can use it in their pre and intra-operative planning.
arm group label: Conventional Imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ivan Wong, Dr.
role: Principal Investigator
affiliation: Nova Scotia Health Authority
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Ivan Wong
investigator title: Principal Investigator
mesh term: Femoracetabular Impingement
sharing ipd: No
ipd description: Individual participant data will not be shared with other researchers.