<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/NCT02981355</url>
  </required_header>
  <id_info>
    <org_study_id>BST-CarGel Pr001</org_study_id>
    <nct_id>NCT02981355</nct_id>
  </id_info>
  <brief_title>Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions</brief_title>
  <acronym>RECORD</acronym>
  <official_title>Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Piramal Healthcare Canada Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Global Research Solutions</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Piramal Healthcare Canada Ltd</source>
  <oversight_info>
    <has_dmc>Yes</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 multi-centre randomized, controlled trial will assess the impact of BST-CarGel scaffold&#xD;
      with microfracture versus microfracture alone on short and long term clinical benefit in&#xD;
      patients with cartilage lesions of the femoral condyle requiring operative management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current standard of treatment for cartilage lesions on the femoral condyle is&#xD;
      microfracture, which is conducted by penetrating the subchondral bone below the lesion. This&#xD;
      procedure creates a natural healing response as a result of the bleeding and clotting caused&#xD;
      by the microfracture, restoring the lesion. BST-CarGel (Piramal Life Sciences,&#xD;
      Bio-Orthopaedic Division), a liquid chitosan-containing polymer scaffolding, has been&#xD;
      developed as an intra-articular injectable scaffold to aid in the stabilization of the blood&#xD;
      clot created by microfracture. BST-CarGel does not interfere with the normal clotting&#xD;
      process; however, it enables a prolonged healing time due to the increased stabilization of&#xD;
      the clot within the lesion and the inhibition of clot retraction.&#xD;
&#xD;
      The RECORD trial is a multi-centre, randomized, controlled trial to assess the impact of the&#xD;
      BST-CarGel scaffold and microfracture versus microfracture alone on short term clinical&#xD;
      benefit as measured by loaded knee pain (single leg squat) on a visual analogue scale (3-6&#xD;
      months), mid-long term clinical benefit as measured by the same loaded knee pain (single leg&#xD;
      squat) (9, 12, and 24 months) and Tegner Activity Score (TAS), International Knee&#xD;
      Documentation Committee (IKDC), and Knee Injury and Osteoarthritis (KOOS) at 3, 6, 9, 12 and&#xD;
      24 months post-operatively. Approximately 158 participants with full-thickness grade III and&#xD;
      IV cartilage lesions will be randomised in a 1:1 ratio to receive one of the two treatments&#xD;
      during an arthroscopic procedure and will be followed for up to 24 months to collect&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Actual">March 6, 2018</completion_date>
  <primary_completion_date type="Actual">March 6, 2018</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in loaded knee pain (single leg squat) visual analogue scale (VAS)</measure>
    <time_frame>Baseline to 24 months post-surgery</time_frame>
    <description>Used to demonstrate patient clinical improvement. The VAS is one of the most commonly used measures of pain intensity, where the patient rates their pain on a scale from 0 to 10 (0=no pain; 10=maximum pain possible).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knee function measured by the TAS questionnaire</measure>
    <time_frame>Baseline to 24 months post-surgery</time_frame>
    <description>The TAS is a validated patient-administered questionnaire for use in multiple knee injuries and consists of a numerical scale ranging from 0 to 10 to indicate the ability to perform specific activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knee function measured by the IKDC questionnaire</measure>
    <time_frame>Baseline to 24 months post-surgery</time_frame>
    <description>The IKDC measures the progress in symptoms, function, and sports activities caused by knee impairment after a treatment has been performed. It can be used with reliability and validity in patients with a range of knee conditions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knee function measured by the KOOS questionnaire</measure>
    <time_frame>Baseline to 24 months post-surgery</time_frame>
    <description>The KOOS is a measure of a patient's perceived knee pain and function, as well as associated problems with their knee status. It contains 42 items that are all recorded on a five-point Likert Scale by the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Repair tissue quantity and quality</measure>
    <time_frame>Up to 24 months post-surgery</time_frame>
    <description>Measured by MOCART Score and percentage lesion fill. The MOCART Score will be completed by two independent, blinded, well-trained radiologist readers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events related to treatment</measure>
    <time_frame>Up to 24 months post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic evaluation</measure>
    <time_frame>surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery</time_frame>
    <description>Measured by study-specific Resource Utilization Questionnaires which will be used to determine the costs associated with the use of the BST-CarGel scaffold treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Traumatic; Lesion</condition>
  <condition>Degenerative Lesion of Articular Cartilage of Knee</condition>
  <arm_group>
    <arm_group_label>Microfracture treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Microfracture surgery of the femoral condyle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BST-CarGel plus microfracture treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BST-CarGel combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following an arthroscopic microfracture surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microfracture treatment</intervention_name>
    <description>Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.</description>
    <arm_group_label>BST-CarGel plus microfracture treatment</arm_group_label>
    <arm_group_label>Microfracture treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BST-CarGel</intervention_name>
    <description>BST-CarGel is combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following microfracture arthroscopic surgery.</description>
    <arm_group_label>BST-CarGel plus microfracture treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  requires cartilage repair treatment due to distal femoral cartilage lesion&#xD;
&#xD;
          -  is 18-55 years of age at the time of surgery&#xD;
&#xD;
          -  has single, focal cartilage lesion on one of the femoral condyles&#xD;
&#xD;
          -  has symptomatic cartilage lesion that has failed conservative management&#xD;
&#xD;
          -  has a single lesion classified as focal, full-thickness grade 3 or 4 according to the&#xD;
             ICRS (3A, 3B, 3C, 3D and 4A)&#xD;
&#xD;
          -  an area of lesion between 1.5-3 cm2 after debridement&#xD;
&#xD;
          -  has a stable knee (&lt;5-mm side-to-side difference on Lachman and varus and valgus&#xD;
             stress testing and grade 0 or 1 on the pivot-shift test) and an intact meniscal rim&#xD;
&#xD;
          -  is willing and able to participate in required follow-up visits at the investigational&#xD;
             site and to complete study procedures and questionnaires and recommended physiotherapy&#xD;
             regimen&#xD;
&#xD;
          -  has agreed to discontinue the use of all knee pain medication 3 days before the&#xD;
             pre-treatment visit and the post-treatment follow-up visits at 3, 6, 9, 12, and 24&#xD;
             months&#xD;
&#xD;
          -  has consented to participating in the study by signing the IRB/EC approved informed&#xD;
             consent form&#xD;
&#xD;
          -  no deep osteochondral defect ( &lt; 5 mm bone loss)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has multiple lesions or kissing (opposing) lesion(s) greater than GII&#xD;
&#xD;
          -  has clinically relevant compartment malalignment (&gt;5°)&#xD;
&#xD;
          -  has bone cyst(s) associated with, or adjacent to, the index lesion&#xD;
&#xD;
          -  has Osteochondritis Dissecans with bone or bone-cartilage fragment in place&#xD;
&#xD;
          -  has had ligament treatments in the index knee within the previous 24 months&#xD;
&#xD;
          -  has had surgical cartilage treatments in the index knee within previous 12 months&#xD;
&#xD;
          -  has had intra-articular injections in the index knee within the previous 2 months&#xD;
&#xD;
          -  has diagnosis of an immunosuppressive disorder&#xD;
&#xD;
          -  has a BMI &gt; 30 kg/m2&#xD;
&#xD;
          -  has concomitant healing bone fractures&#xD;
&#xD;
          -  has a single lesion classified as focal, full-thickness grade 4B as defined by ICRS&#xD;
&#xD;
          -  has noteworthy pain in the ipsilateral hip or ankle or contralateral hip, knee, or&#xD;
             ankle&#xD;
&#xD;
          -  has inflammatory arthropathy&#xD;
&#xD;
          -  has blood clotting disorders, was receiving anticoagulant therapy, or has recurring&#xD;
             deep vein thrombosis&#xD;
&#xD;
          -  has a serious heart condition or liver and/or renal abnormalities diagnosed within the&#xD;
             previous 24 months&#xD;
&#xD;
          -  has chronic infection of the lower joint extremities&#xD;
&#xD;
          -  has a history of alcohol or drug abuse within the previous 12 months&#xD;
&#xD;
          -  is facing current or impending incarceration&#xD;
&#xD;
          -  has a known allergy to shellfish&#xD;
&#xD;
          -  is pregnant or plans to become pregnant during the course of the study&#xD;
&#xD;
          -  in the opinion of the PI, has an emotional or neurological condition that would&#xD;
             pre-empt their ability or willingness to participate in the study including mental&#xD;
             illness, drug or alcohol abuse&#xD;
&#xD;
          -  chronic knee pain&#xD;
&#xD;
          -  has a documented medical history of vitamin-D deficiency that is not being managed&#xD;
             with supplementation&#xD;
&#xD;
          -  is entered in another investigational drug, biologic, or device study or has been&#xD;
             treated with an investigational product in the past 30 days&#xD;
&#xD;
          -  requires an open procedure&#xD;
&#xD;
          -  is known to be at risk for lost to follow-up, or failure to return for scheduled&#xD;
             visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Pierre Desmarais</last_name>
    <role>Study Chair</role>
    <affiliation>Piramal Healthcare Canada Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Calvary Wakefield Hospital</name>
      <address>
        <city>Adelaide</city>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Murdoch Orthopaedic Clinic</name>
      <address>
        <city>Murdoch</city>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banff Sport Medicine</name>
      <address>
        <city>Banff</city>
        <zip>T1L1B3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fowler Kennedy Sport Medicine Clinic</name>
      <address>
        <city>London</city>
        <zip>N6A3K7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <zip>H1T4B3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de La Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Nancy - Hospital Central</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93042</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quironsalud Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SportClinic Zurich / Hirslanden Clinic</name>
      <address>
        <city>Zurich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Orthopaedic Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B312AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton</name>
      <address>
        <city>Southampton</city>
        <zip>S0166YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Netherlands</country>
  </removed_countries>
  <results_reference>
    <citation>Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Methot S, Vehik K, Restrepo A. BST-CarGel(R) Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilage. 2015 Apr;6(2):62-72. doi: 10.1177/1947603514562064.</citation>
    <PMID>26069709</PMID>
  </results_reference>
  <results_reference>
    <citation>Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.</citation>
    <PMID>24048551</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 30, 2018</last_update_submitted>
  <last_update_submitted_qc>October 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BST-CarGel</keyword>
  <keyword>Microfracture</keyword>
  <keyword>Cartilage Lesion, Chondral Lesion</keyword>
  <keyword>Femoral condyle</keyword>
  <keyword>Bone Marrow Stimulation</keyword>
  <keyword>Cartilage Repair</keyword>
  <keyword>Tear of Articular Cartilage of Knee, Current</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Stress</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/NCT02981355
org study id: BST-CarGel Pr001
nct id: NCT02981355
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This multi-centre randomized, controlled trial will assess the impact of BST-CarGel scaffold
      with microfracture versus microfracture alone on short and long term clinical benefit in
      patients with cartilage lesions of the femoral condyle requiring operative management.
The current standard of treatment for cartilage lesions on the femoral condyle is
      microfracture, which is conducted by penetrating the subchondral bone below the lesion. This
      procedure creates a natural healing response as a result of the bleeding and clotting caused
      by the microfracture, restoring the lesion. BST-CarGel (Piramal Life Sciences,
      Bio-Orthopaedic Division), a liquid chitosan-containing polymer scaffolding, has been
      developed as an intra-articular injectable scaffold to aid in the stabilization of the blood
      clot created by microfracture. BST-CarGel does not interfere with the normal clotting
      process; however, it enables a prolonged healing time due to the increased stabilization of
      the clot within the lesion and the inhibition of clot retraction.

      The RECORD trial is a multi-centre, randomized, controlled trial to assess the impact of the
      BST-CarGel scaffold and microfracture versus microfracture alone on short term clinical
      benefit as measured by loaded knee pain (single leg squat) on a visual analogue scale (3-6
      months), mid-long term clinical benefit as measured by the same loaded knee pain (single leg
      squat) (9, 12, and 24 months) and Tegner Activity Score (TAS), International Knee
      Documentation Committee (IKDC), and Knee Injury and Osteoarthritis (KOOS) at 3, 6, 9, 12 and
      24 months post-operatively. Approximately 158 participants with full-thickness grade III and
      IV cartilage lesions will be randomised in a 1:1 ratio to receive one of the two treatments
      during an arthroscopic procedure and will be followed for up to 24 months to collect
      outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in loaded knee pain (single leg squat) visual analogue scale (VAS)
time frame: Baseline to 24 months post-surgery
description: Used to demonstrate patient clinical improvement. The VAS is one of the most commonly used measures of pain intensity, where the patient rates their pain on a scale from 0 to 10 (0=no pain; 10=maximum pain possible).
measure: Change in knee function measured by the TAS questionnaire
time frame: Baseline to 24 months post-surgery
description: The TAS is a validated patient-administered questionnaire for use in multiple knee injuries and consists of a numerical scale ranging from 0 to 10 to indicate the ability to perform specific activities.
measure: Change in knee function measured by the IKDC questionnaire
time frame: Baseline to 24 months post-surgery
description: The IKDC measures the progress in symptoms, function, and sports activities caused by knee impairment after a treatment has been performed. It can be used with reliability and validity in patients with a range of knee conditions.
measure: Change in knee function measured by the KOOS questionnaire
time frame: Baseline to 24 months post-surgery
description: The KOOS is a measure of a patient's perceived knee pain and function, as well as associated problems with their knee status. It contains 42 items that are all recorded on a five-point Likert Scale by the patient.
measure: Repair tissue quantity and quality
time frame: Up to 24 months post-surgery
description: Measured by MOCART Score and percentage lesion fill. The MOCART Score will be completed by two independent, blinded, well-trained radiologist readers.
measure: Adverse events related to treatment
time frame: Up to 24 months post-surgery
measure: Economic evaluation
time frame: surgical visit, 2 weeks, 6 weeks, 3 months, 6 months, 9 months,12 months and 24 months post-surgery
description: Measured by study-specific Resource Utilization Questionnaires which will be used to determine the costs associated with the use of the BST-CarGel scaffold treatment.
arm group label: Microfracture treatment
arm group type: Active Comparator
description: Microfracture surgery of the femoral condyle
arm group label: BST-CarGel plus microfracture treatment
arm group type: Experimental
description: BST-CarGel combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following an arthroscopic microfracture surgery.
intervention type: Procedure
intervention name: Microfracture treatment
description: Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.
arm group label: BST-CarGel plus microfracture treatment
arm group label: Microfracture treatment
intervention type: Device
intervention name: BST-CarGel
description: BST-CarGel is combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following microfracture arthroscopic surgery.
arm group label: BST-CarGel plus microfracture treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Jean-Pierre Desmarais
role: Study Chair
affiliation: Piramal Healthcare Canada Ltd
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: France
country: Germany
country: Spain
country: Switzerland
country: United Kingdom
country: Netherlands
citation: Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Methot S, Vehik K, Restrepo A. BST-CarGel(R) Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilage. 2015 Apr;6(2):62-72. doi: 10.1177/1947603514562064.
PMID: 26069709
citation: Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.
PMID: 24048551
responsible party type: Sponsor
mesh term: Fractures, Stress
sharing ipd: No