xml: <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/NCT06024798</url>
    </required_header>
    <id_info>
      <org_study_id>W1024</org_study_id>
      <nct_id>NCT06024798</nct_id>
    </id_info>
    <brief_title>Detecting and Assessing Leg and Foot Stress Fractures Using Photon Counting CT</brief_title>
    <acronym>FootPCCT</acronym>
    <official_title>Assessing Patients With Suspected Stress or Insufficiency Fracture of the Lower Extremity With Photon-Counting-Computed-Tomography</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Balgrist University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Balgrist University 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>
        Stress fractures (fatigue or insufficiency fracture) are caused by the mismatch between bone&#xD;
        strength and chronic stress applied to the bone. The vast majority of these fractures occur&#xD;
        in the lower extremity. Early-stage diagnosis is crucial to optimize patient care.&#xD;
        Appropriate imaging is relevant in confirming diagnosis after clinical suspicion of stress&#xD;
        fractures. Radiographs have low sensitivity, so a relevant number of fractures go undetected.&#xD;
        MRI has a high sensitivity, but its availability is limited, and its respective examination&#xD;
        time is prolonged. This study investigates the diagnostic accuracy of PCCT in lower extremity&#xD;
        stress fractures as a dose-saving technology, guaranteeing an examination according to the&#xD;
        ALARA-principle (as low as reasonably achievable).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Stress fracture is caused by the mismatch between bone strength and chronical stress applied&#xD;
        to the bone, which is insufficient to cause an acute fracture, but a stress fracture does not&#xD;
        heal itself. One can subclassify it into fatigue fracture (overuse of a healthy bone) and&#xD;
        insufficiency fracture (normal use of a weakened bone). Fatigue fractures usually happen in&#xD;
        healthy athletes or military recruits, whereas insufficiency fracture appear in patients with&#xD;
        underlying metabolic or nutritional disorder (e.g. osteoporosis). On radiographs and Computed&#xD;
        Tomography (CT), stress fractures are defined as round or linear intracortical lucency or an&#xD;
        intertrabecular sclerotic line, which rarely intersects the cortex. Radiograph is a&#xD;
        cost-effective and highly available modality in detecting fractures, showing however a&#xD;
        moderate sensitivity in detecting stress fractures: 15-35% on the initial and 30-70% on the&#xD;
        follow-up imaging. CT, another modality highly available in most hospital settings, shows a&#xD;
        similar moderate sensitivity of 32-38% with however a corresponding high specificity of&#xD;
        88-98% on initial imaging. Similar specificity values can be observed for magnetic resonance&#xD;
        imaging (MRI) and nuclear scintigraphy. Although their availability is limited and their&#xD;
        respective examination time is prolonged, they outperform the x-ray based technologies in&#xD;
        term of sensitivity (68-98% MRI and 50-97% nuclear scintigraphy, respectively).&#xD;
  &#xD;
        The introduction of dual-energy technology advanced CT from a pure anatomical evaluation tool&#xD;
        to a combined anatomical and functional modality. Every material has a specific absorption&#xD;
        number, which can be assessed by applying two different energies (high and low x-ray tube&#xD;
        voltages). This method of multispectral imaging has been established and clinically&#xD;
        implemented in detecting gout and characterizing renal stones. Further studies have shown&#xD;
        that DECT can depict bone marrow edema, a marker of early stress fracture and a common&#xD;
        finding in MRI. However, this has yet not been implemented in clinical practice.&#xD;
  &#xD;
        The photon-counting-computed-tomography (PCCT) has been introduced recently, enabling an&#xD;
        energy dependent separation of photons over the whole x-ray energy spectrum. This results in&#xD;
        reduced background noise, improved image resolution and multispectral imaging without the&#xD;
        necessity of an additional acquisition at a different energy level. An initial study has&#xD;
        shown already shown the superiority of PCCT by better detecting and characterizing small&#xD;
        renal stones, when compared to conventional dual-energy computed tomography (DECT).&#xD;
  &#xD;
        In this project the investigators aim to include clinically referred patients with suspected&#xD;
        stress fracture of the lower extremity who will have an MRI to confirm the diagnosis of a&#xD;
        suspected stress fracture. The subjects will be scanned on the new PCCT system with dose&#xD;
        saving technology, guaranteeing an examination according to the ALARA-principle (as low as&#xD;
        reasonably achievable). The investigators will not inject iodine contrast media and they will&#xD;
        expect a median dose of 2-4 mSv (millisieverts). Since this will not exceed the threshold of&#xD;
        5 mSv, this project will be classified as category A.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>13 Weeks</target_duration>
    <primary_outcome>
      <measure>Presence of a fracture</measure>
      <time_frame>Day 1, 4weeks follow up assessment</time_frame>
      <description>Presence/absence of a fracture</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Presence of bone edema</measure>
      <time_frame>Day 1, 4weeks follow up assessment</time_frame>
      <description>Presence/absence of bone edema</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of soft tissue edema</measure>
      <time_frame>Day1, 4weeks follow up assessment</time_frame>
      <description>Presence/absence of soft tissue edema</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pain localization</measure>
      <time_frame>Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment</time_frame>
      <description>Pain localization will be done through a clear statement of anatomical location</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain character</measure>
      <time_frame>Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment</time_frame>
      <description>Pain will be characterized using the following terms: sharp, dull, aching, burning, radiating, numbing, and pulsating.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain intensity</measure>
      <time_frame>Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment</time_frame>
      <description>Pain intensity will be described using the Number Rating Scale (NRS): a score of 0 corresponds to the absence of pain, while a score of 10 indicates the most intense pain ever experienced.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain duration</measure>
      <time_frame>Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment</time_frame>
      <description>Pain duration is described in days (d).</description>
    </other_outcome>
    <other_outcome>
      <measure>Karlsson Scoring Scale: Patient reported outcome regarding the stress fracture</measure>
      <time_frame>Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment</time_frame>
      <description>The Karlsson scoring scale is utilized to evaluate and quantify both the functional status and the extent to which the stress fracture affects an individual's quality of life. The scoring system comprises a total of 90 points, where 0 points represent the most severe condition and 90 points indicate an absence of any issues.</description>
    </other_outcome>
    <other_outcome>
      <measure>Foot Function Index: Patient reported outcome regarding the stress fracture</measure>
      <time_frame>Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment</time_frame>
      <description>The Foot Function Index is utilized to evaluate and quantify both the functional status and the extent to which the stress fracture affects an individual's quality of life. The minimum score is 0% (no pain or difficulty), and maximum score is 100%</description>
    </other_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Stress Fracture Foot</condition>
    <condition>Stress Fracture Ankle</condition>
    <condition>Stress Fracture of Tibia</condition>
    <condition>Stress Fracture Metatarsal</condition>
    <condition>Lower Limb Fracture</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Photon-Counting-Computed-Tomography</intervention_name>
      <description>Initial and follow up (after 4 weeks) PCCT acquisition of the affected area of the lower extremity. Image acquisition will be performed on the PCCT</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          In cooperation with the Foot Clinic at the Balgrist University Hospital Zurich, potential&#xD;
          study candidates with suspected stress fracture who will undergo an MRI to confirm the&#xD;
          diagnosis are prospectively screened and proposed to join the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥ 16 years of age. Minor study subjects can have an additional signature by the parent&#xD;
               or legal guardian&#xD;
  &#xD;
            -  Clinically suspected stress or insufficiency fracture of the lower extremity&#xD;
  &#xD;
            -  Written consent of study participation&#xD;
  &#xD;
            -  Patients who will have an MRI to confirm the diagnosis of a suspected stress fracture&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt; 16 years of age&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Metal implants&#xD;
  &#xD;
            -  Postoperative situation&#xD;
  &#xD;
            -  Infection or tumorous disease affecting the lower extremity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stephan Wirth, PD Dr.med.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Balgrist University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Viehöfer Arnd, PD Dr.med.</last_name>
      <phone>+41 44 386 57 55</phone>
      <email>Arnd.Viehöfer@balgrist.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zendeli Flamur</last_name>
      <phone>+41 44 386 56 72</phone>
      <email>Flamur.Zendeli@balgrist.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Balgrist University Hospital</name>
        <address>
          <city>Zürich</city>
          <state>Zurich</state>
          <zip>8008</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Stephan Wirth, PD Dr.med.</last_name>
        <phone>+41 44 386 11 11</phone>
        <email>Stephan.Wirth@balgrist.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <link>
      <url>https://ssrpm.ch/wp-content/uploads/2021/01/Report-21.pdf</url>
      <description>Report on the use of patient shielding in radiological procedures Swiss Society of Radiobiology and Medical Physics.</description>
    </link>
    <reference>
      <citation>Palmer W, Bancroft L, Bonar F, Choi JA, Cotten A, Griffith JF, Robinson P, Pfirrmann CWA. Glossary of terms for musculoskeletal radiology. Skeletal Radiol. 2020 Jul;49(Suppl 1):1-33. doi: 10.1007/s00256-020-03465-1. Epub 2020 Jun 2.</citation>
      <PMID>32488336</PMID>
    </reference>
    <reference>
      <citation>Lassus J, Tulikoura I, Konttinen YT, Salo J, Santavirta S. Bone stress injuries of the lower extremity: a review. Acta Orthop Scand. 2002 Jun;73(3):359-68. doi: 10.1080/000164702320155392.</citation>
      <PMID>12143987</PMID>
    </reference>
    <reference>
      <citation>Wright AA, Hegedus EJ, Lenchik L, Kuhn KJ, Santiago L, Smoliga JM. Diagnostic Accuracy of Various Imaging Modalities for Suspected Lower Extremity Stress Fractures: A Systematic Review With Evidence-Based Recommendations for Clinical Practice. Am J Sports Med. 2016 Jan;44(1):255-63. doi: 10.1177/0363546515574066. Epub 2015 Mar 24.</citation>
      <PMID>25805712</PMID>
    </reference>
    <reference>
      <citation>Wortman JR, Uyeda JW, Fulwadhva UP, Sodickson AD. Dual-Energy CT for Abdominal and Pelvic Trauma. Radiographics. 2018 Mar-Apr;38(2):586-602. doi: 10.1148/rg.2018170058.</citation>
      <PMID>29528816</PMID>
    </reference>
    <reference>
      <citation>Cabarrus MC, Ambekar A, Lu Y, Link TM. MRI and CT of insufficiency fractures of the pelvis and the proximal femur. AJR Am J Roentgenol. 2008 Oct;191(4):995-1001. doi: 10.2214/AJR.07.3714.</citation>
      <PMID>18806133</PMID>
    </reference>
    <reference>
      <citation>Gosangi B, Mandell JC, Weaver MJ, Uyeda JW, Smith SE, Sodickson AD, Khurana B. Bone Marrow Edema at Dual-Energy CT: A Game Changer in the Emergency Department. Radiographics. 2020 May-Jun;40(3):859-874. doi: 10.1148/rg.2020190173.</citation>
      <PMID>32364883</PMID>
    </reference>
    <reference>
      <citation>Grunz JP, Sailer L, Lang P, Schule S, Kunz AS, Beer M, Hackenbroch C. Dual-energy CT in sacral fragility fractures: defining a cut-off Hounsfield unit value for the presence of traumatic bone marrow edema in patients with osteoporosis. BMC Musculoskelet Disord. 2022 Jul 29;23(1):724. doi: 10.1186/s12891-022-05690-2.</citation>
      <PMID>35906573</PMID>
    </reference>
    <reference>
      <citation>Henes FO, Nuchtern JV, Groth M, Habermann CR, Regier M, Rueger JM, Adam G, Grossterlinden LG. Comparison of diagnostic accuracy of Magnetic Resonance Imaging and Multidetector Computed Tomography in the detection of pelvic fractures. Eur J Radiol. 2012 Sep;81(9):2337-42. doi: 10.1016/j.ejrad.2011.07.012. Epub 2011 Sep 15.</citation>
      <PMID>21924851</PMID>
    </reference>
    <reference>
      <citation>Bongartz T, Glazebrook KN, Kavros SJ, Murthy NS, Merry SP, Franz WB 3rd, Michet CJ, Veetil BM, Davis JM 3rd, Mason TG 2nd, Warrington KJ, Ytterberg SR, Matteson EL, Crowson CS, Leng S, McCollough CH. Dual-energy CT for the diagnosis of gout: an accuracy and diagnostic yield study. Ann Rheum Dis. 2015 Jun;74(6):1072-7. doi: 10.1136/annrheumdis-2013-205095. Epub 2014 Mar 25.</citation>
      <PMID>24671771</PMID>
    </reference>
    <reference>
      <citation>Hidas G, Eliahou R, Duvdevani M, Coulon P, Lemaitre L, Gofrit ON, Pode D, Sosna J. Determination of renal stone composition with dual-energy CT: in vivo analysis and comparison with x-ray diffraction. Radiology. 2010 Nov;257(2):394-401. doi: 10.1148/radiol.10100249. Epub 2010 Aug 31.</citation>
      <PMID>20807846</PMID>
    </reference>
    <reference>
      <citation>Esquivel A, Ferrero A, Mileto A, Baffour F, Horst K, Rajiah PS, Inoue A, Leng S, McCollough C, Fletcher JG. Photon-Counting Detector CT: Key Points Radiologists Should Know. Korean J Radiol. 2022 Sep;23(9):854-865. doi: 10.3348/kjr.2022.0377.</citation>
      <PMID>36047540</PMID>
    </reference>
    <reference>
      <citation>Marcus RP, Fletcher JG, Ferrero A, Leng S, Halaweish AF, Gutjahr R, Vrtiska TJ, Wells ML, Enders FT, McCollough CH. Detection and Characterization of Renal Stones by Using Photon-Counting-based CT. Radiology. 2018 Nov;289(2):436-442. doi: 10.1148/radiol.2018180126. Epub 2018 Aug 7.</citation>
      <PMID>30084728</PMID>
    </reference>
    <reference>
      <citation>Tenforde AS, Fredericson M. Influence of sports participation on bone health in the young athlete: a review of the literature. PM R. 2011 Sep;3(9):861-7. doi: 10.1016/j.pmrj.2011.05.019.</citation>
      <PMID>21944303</PMID>
    </reference>
    <reference>
      <citation>Grunz JP, Heidenreich JF, Lennartz S, Weighardt JP, Bley TA, Ergun S, Petritsch B, Huflage H. Spectral Shaping Via Tin Prefiltration in Ultra-High-Resolution Photon-Counting and Energy-Integrating Detector CT of the Temporal Bone. Invest Radiol. 2022 Dec 1;57(12):819-825. doi: 10.1097/RLI.0000000000000901. Epub 2022 Jun 24.</citation>
      <PMID>35776435</PMID>
    </reference>
    <reference>
      <citation>Grunz JP, Petritsch B, Luetkens KS, Kunz AS, Lennartz S, Ergun S, Bley TA, Huflage H. Ultra-Low-Dose Photon-Counting CT Imaging of the Paranasal Sinus With Tin Prefiltration: How Low Can We Go? Invest Radiol. 2022 Nov 1;57(11):728-733. doi: 10.1097/RLI.0000000000000887. Epub 2022 May 6.</citation>
      <PMID>35703452</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Fractures, Stress</mesh_term>
      <mesh_term>Tibial Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024798
  org study id: W1024
  nct id: NCT06024798
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Stress fractures (fatigue or insufficiency fracture) are caused by the mismatch between bone
        strength and chronic stress applied to the bone. The vast majority of these fractures occur
        in the lower extremity. Early-stage diagnosis is crucial to optimize patient care.
        Appropriate imaging is relevant in confirming diagnosis after clinical suspicion of stress
        fractures. Radiographs have low sensitivity, so a relevant number of fractures go undetected.
        MRI has a high sensitivity, but its availability is limited, and its respective examination
        time is prolonged. This study investigates the diagnostic accuracy of PCCT in lower extremity
        stress fractures as a dose-saving technology, guaranteeing an examination according to the
        ALARA-principle (as low as reasonably achievable).
  Stress fracture is caused by the mismatch between bone strength and chronical stress applied
        to the bone, which is insufficient to cause an acute fracture, but a stress fracture does not
        heal itself. One can subclassify it into fatigue fracture (overuse of a healthy bone) and
        insufficiency fracture (normal use of a weakened bone). Fatigue fractures usually happen in
        healthy athletes or military recruits, whereas insufficiency fracture appear in patients with
        underlying metabolic or nutritional disorder (e.g. osteoporosis). On radiographs and Computed
        Tomography (CT), stress fractures are defined as round or linear intracortical lucency or an
        intertrabecular sclerotic line, which rarely intersects the cortex. Radiograph is a
        cost-effective and highly available modality in detecting fractures, showing however a
        moderate sensitivity in detecting stress fractures: 15-35% on the initial and 30-70% on the
        follow-up imaging. CT, another modality highly available in most hospital settings, shows a
        similar moderate sensitivity of 32-38% with however a corresponding high specificity of
        88-98% on initial imaging. Similar specificity values can be observed for magnetic resonance
        imaging (MRI) and nuclear scintigraphy. Although their availability is limited and their
        respective examination time is prolonged, they outperform the x-ray based technologies in
        term of sensitivity (68-98% MRI and 50-97% nuclear scintigraphy, respectively).
  
        The introduction of dual-energy technology advanced CT from a pure anatomical evaluation tool
        to a combined anatomical and functional modality. Every material has a specific absorption
        number, which can be assessed by applying two different energies (high and low x-ray tube
        voltages). This method of multispectral imaging has been established and clinically
        implemented in detecting gout and characterizing renal stones. Further studies have shown
        that DECT can depict bone marrow edema, a marker of early stress fracture and a common
        finding in MRI. However, this has yet not been implemented in clinical practice.
  
        The photon-counting-computed-tomography (PCCT) has been introduced recently, enabling an
        energy dependent separation of photons over the whole x-ray energy spectrum. This results in
        reduced background noise, improved image resolution and multispectral imaging without the
        necessity of an additional acquisition at a different energy level. An initial study has
        shown already shown the superiority of PCCT by better detecting and characterizing small
        renal stones, when compared to conventional dual-energy computed tomography (DECT).
  
        In this project the investigators aim to include clinically referred patients with suspected
        stress fracture of the lower extremity who will have an MRI to confirm the diagnosis of a
        suspected stress fracture. The subjects will be scanned on the new PCCT system with dose
        saving technology, guaranteeing an examination according to the ALARA-principle (as low as
        reasonably achievable). The investigators will not inject iodine contrast media and they will
        expect a median dose of 2-4 mSv (millisieverts). Since this will not exceed the threshold of
        5 mSv, this project will be classified as category A.
  observational model: Case-Only
  time perspective: Prospective
  measure: Presence of a fracture
  time frame: Day 1, 4weeks follow up assessment
  description: Presence/absence of a fracture
  measure: Presence of bone edema
  time frame: Day 1, 4weeks follow up assessment
  description: Presence/absence of bone edema
  measure: Presence of soft tissue edema
  time frame: Day1, 4weeks follow up assessment
  description: Presence/absence of soft tissue edema
  measure: Pain localization
  time frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
  description: Pain localization will be done through a clear statement of anatomical location
  measure: Pain character
  time frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
  description: Pain will be characterized using the following terms: sharp, dull, aching, burning, radiating, numbing, and pulsating.
  measure: Pain intensity
  time frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
  description: Pain intensity will be described using the Number Rating Scale (NRS): a score of 0 corresponds to the absence of pain, while a score of 10 indicates the most intense pain ever experienced.
  measure: Pain duration
  time frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
  description: Pain duration is described in days (d).
  measure: Karlsson Scoring Scale: Patient reported outcome regarding the stress fracture
  time frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
  description: The Karlsson scoring scale is utilized to evaluate and quantify both the functional status and the extent to which the stress fracture affects an individual's quality of life. The scoring system comprises a total of 90 points, where 0 points represent the most severe condition and 90 points indicate an absence of any issues.
  measure: Foot Function Index: Patient reported outcome regarding the stress fracture
  time frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
  description: The Foot Function Index is utilized to evaluate and quantify both the functional status and the extent to which the stress fracture affects an individual's quality of life. The minimum score is 0% (no pain or difficulty), and maximum score is 100%
  intervention type: Diagnostic Test
  intervention name: Photon-Counting-Computed-Tomography
  description: Initial and follow up (after 4 weeks) PCCT acquisition of the affected area of the lower extremity. Image acquisition will be performed on the PCCT
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stephan Wirth, PD Dr.med.
  role: Principal Investigator
  affiliation: Balgrist University Hospital
  last name: Viehöfer Arnd, PD Dr.med.
  phone: +41 44 386 57 55
  email: Arnd.Viehöfer@balgrist.ch
  last name: Zendeli Flamur
  phone: +41 44 386 56 72
  email: Flamur.Zendeli@balgrist.ch
  facility: 
  contact: 
  country: Switzerland
  url: https://ssrpm.ch/wp-content/uploads/2021/01/Report-21.pdf
  description: Report on the use of patient shielding in radiological procedures Swiss Society of Radiobiology and Medical Physics.
  citation: Palmer W, Bancroft L, Bonar F, Choi JA, Cotten A, Griffith JF, Robinson P, Pfirrmann CWA. Glossary of terms for musculoskeletal radiology. Skeletal Radiol. 2020 Jul;49(Suppl 1):1-33. doi: 10.1007/s00256-020-03465-1. Epub 2020 Jun 2.
  PMID: 32488336
  citation: Lassus J, Tulikoura I, Konttinen YT, Salo J, Santavirta S. Bone stress injuries of the lower extremity: a review. Acta Orthop Scand. 2002 Jun;73(3):359-68. doi: 10.1080/000164702320155392.
  PMID: 12143987
  citation: Wright AA, Hegedus EJ, Lenchik L, Kuhn KJ, Santiago L, Smoliga JM. Diagnostic Accuracy of Various Imaging Modalities for Suspected Lower Extremity Stress Fractures: A Systematic Review With Evidence-Based Recommendations for Clinical Practice. Am J Sports Med. 2016 Jan;44(1):255-63. doi: 10.1177/0363546515574066. Epub 2015 Mar 24.
  PMID: 25805712
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  responsible party type: Sponsor
  mesh term: Fractures, Bone
  mesh term: Fractures, Stress
  mesh term: Tibial Fractures
  sharing ipd: No