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/NCT05971745</url>
    </required_header>
    <id_info>
      <org_study_id>19-117</org_study_id>
      <nct_id>NCT05971745</nct_id>
    </id_info>
    <brief_title>Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound</brief_title>
    <official_title>Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Connecticut Children's Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Newark Beth Israel Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Cohen Children's Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Gold Coast Hospital and Health Service</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Connecticut Children's Medical Center</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>
        The purpose of this study is to determine if pediatric emergency medicine providers can&#xD;
        accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to&#xD;
        radiology ultrasound (RADUS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to determine that the accuracy of trained pediatric emergency&#xD;
        medicine providers to diagnose hip effusion using point-of-care ultrasound (POCUS) is&#xD;
        non-inferior to the reference standard of radiology ultrasound (RADUS). Additionally, the&#xD;
        investigators seek to compare how POCUS performs against other clinical tests or&#xD;
        investigations for the diagnosis of septic arthritis. The investigators hypothesize that&#xD;
        trained EM providers will be able to diagnose hip effusions with high (&gt;90%) accuracy&#xD;
        compared to studies conducted by the Department of Radiology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 15, 2019</start_date>
    <completion_date type="Anticipated">April 25, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 25, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The presence or absence of a hip effusion.</measure>
      <time_frame>From the time the point-of-care ultrasound is performed by the physician during the emergency department visit through study completion, average of 2 years.</time_frame>
      <description>The presence or absence of an effusion as determined by the pediatric emergency medicine physician performing the point-of-care-ultrasound study on both the affected and unaffected sides (i.e. right hip and left hip).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The presence of absence of a hip effusion.</measure>
      <time_frame>From the time the radiologist reviews the ultrasound as performed by the radiology technician during the emergency department visit, through study completion, average of 2 years.</time_frame>
      <description>The presence or absence of an effusion as determined by the Radiologist on both the affected and unaffected sides.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The size of the effusion.</measure>
      <time_frame>From the time the point-of-care ultrasound is performed by the physician during the emergency department visit to study completion, average of 2 years</time_frame>
      <description>As measured by the pediatric emergency medicine provider in millimeters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The location of the measurement of the effusion.</measure>
      <time_frame>Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.</time_frame>
      <description>Pediatric emergency medicine physicians will measure an effusion at two designated locations. One location is based off of current published literature whereas the second is to provide a comparison to determine if the exact location alters the final diagnosis (effusion or no effusion). Investigators will determine whether the location along the angle of the neck affects the measurement obtained when compared with the current standard practice of measuring fluid along the widest part of the femoral neck.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Number of point-of-care ultrasound studies performed by PEM providers that have a different final diagnosis when compared to radiology ultrasound.</measure>
      <time_frame>Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.</time_frame>
      <description>Investigators will compare the final diagnosis (hip effusion or no hip effusion) between point-of-care-ultrasound and radiology ultrasound to determine the number of discrepancies between the groups.</description>
    </other_outcome>
    <other_outcome>
      <measure>Association between negative point-of-care ultrasound and low to moderate Kocher score.</measure>
      <time_frame>Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.</time_frame>
      <description>Investigators will determine whether the use of ultrasonography in patients with low or moderate Kocher score improves the ability to rule out septic arthritis.</description>
    </other_outcome>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Hip Effusion</condition>
    <condition>Septic Arthritis</condition>
    <condition>Transient Synovitis, Hip</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The target population are children 18 years and younger presenting to the Emergency&#xD;
          Department at Connecticut Children's Medical Center with a chief complaint that&#xD;
          necessitates hip ultrasonography as determined by the physician caring for the patient at&#xD;
          the time of the visit. Those presenting during the study period of October 2019-December&#xD;
          2023 will be recruited. This is a multi-center, international study that will also be&#xD;
          conducted in the Pediatric Emergency Departments at the following institutions: Connecticut&#xD;
          Children's, Cohen Children's Medical Center, New York-Presbyterian / Columbia University&#xD;
          Medical Center, Yale New Haven Hospital, Newark Beth Israel Medical Center, and Gold Coast&#xD;
          Hospital (Queensland, Australia).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years or younger&#xD;
  &#xD;
            -  Clinical presentation necessitating hip ultrasonography as determined by the&#xD;
               evaluating clinician&#xD;
  &#xD;
            -  Study physician available at the time of presentation to ED&#xD;
  &#xD;
            -  Patient or legal guardian provides consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children who present when a study physician is not available or those for whom consent&#xD;
               is not given.&#xD;
  &#xD;
            -  Children who have had hip ultrasound imaging prior to their ED visit. Children with&#xD;
               prior hip/pelvis x-rays will not be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ruchika M Jones, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Connecticut Children's</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ruchika M Jones, MD, MS</last_name>
      <phone>860-837-5596</phone>
      <email>rjones@connecticutchildrens.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ruchika M Jones</name>
        <address>
          <city>Hartford</city>
          <state>Connecticut</state>
          <zip>06106</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ruchika M Jones, MD, MS</last_name>
        <email>RJones@connecticutchildrens.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Yale University</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06550</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Antonio Riera, MD</last_name>
        <phone>203-737-7439</phone>
        <email>antonio.riera@yale.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Newark Beth Israel Medical Center</name>
        <address>
          <city>Newark</city>
          <state>New Jersey</state>
          <zip>07112</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Adam Sivitz, MD</last_name>
        <phone>973-740-0607</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cohen Children's Medical Center</name>
        <address>
          <city>New Hyde Park</city>
          <state>New York</state>
          <zip>11042</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>William Mak, DO</last_name>
        <phone>718-470-3247</phone>
        <email>wmak1@northwell.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Columbia University Medical Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10032</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Laurie A Malia, DO</last_name>
        <phone>646-317-4590</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Gold Coast Hospital and Health Service</name>
        <address>
          <city>Southport</city>
          <state>Queensland</state>
          <zip>4211</zip>
          <country>Australia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peter J Snelling, MBBS</last_name>
        <email>p.snelling@uq.edu.au</email>
      </contact>
    </location>
    <location_countries>
      <country>Australia</country>
      <country>United States</country>
    </location_countries>
    <results_reference>
      <citation>Caird MS, Flynn JM, Leung YL, Millman JE, D'Italia JG, Dormans JP. Factors distinguishing septic arthritis from transient synovitis of the hip in children. A prospective study. J Bone Joint Surg Am. 2006 Jun;88(6):1251-7. doi: 10.2106/JBJS.E.00216.</citation>
      <PMID>16757758</PMID>
    </results_reference>
    <results_reference>
      <citation>Kocher MS, Zurakowski D, Kasser JR. Differentiating between septic arthritis and transient synovitis of the hip in children: an evidence-based clinical prediction algorithm. J Bone Joint Surg Am. 1999 Dec;81(12):1662-70. doi: 10.2106/00004623-199912000-00002.</citation>
      <PMID>10608376</PMID>
    </results_reference>
    <results_reference>
      <citation>Klein DM, Barbera C, Gray ST, Spero CR, Perrier G, Teicher JL. Sensitivity of objective parameters in the diagnosis of pediatric septic hips. Clin Orthop Relat Res. 1997 May;(338):153-9. doi: 10.1097/00003086-199705000-00022.</citation>
      <PMID>9170376</PMID>
    </results_reference>
    <results_reference>
      <citation>Del Beccaro MA, Champoux AN, Bockers T, Mendelman PM. Septic arthritis versus transient synovitis of the hip: the value of screening laboratory tests. Ann Emerg Med. 1992 Dec;21(12):1418-22. doi: 10.1016/s0196-0644(05)80052-6.</citation>
      <PMID>1443834</PMID>
    </results_reference>
    <results_reference>
      <citation>Fabry G, Meire E. Septic arthritis of the hip in children: poor results after late and inadequate treatment. J Pediatr Orthop. 1983 Sep;3(4):461-6. doi: 10.1097/01241398-198309000-00008.</citation>
      <PMID>6630490</PMID>
    </results_reference>
    <results_reference>
      <citation>Lunseth PA, Heiple KG. Prognosis in septic arthritis of the hip in children. Clin Orthop Relat Res. 1979 Mar-Apr;(139):81-5.</citation>
      <PMID>455855</PMID>
    </results_reference>
    <results_reference>
      <citation>Hallel T, Salvati EA. Septic arthritis of the hip in infancy: end result study. Clin Orthop Relat Res. 1978 May;(132):115-28.</citation>
      <PMID>307996</PMID>
    </results_reference>
    <results_reference>
      <citation>Bennett OM, Namnyak SS. Acute septic arthritis of the hip joint in infancy and childhood. Clin Orthop Relat Res. 1992 Aug;(281):123-32.</citation>
      <PMID>1499198</PMID>
    </results_reference>
    <results_reference>
      <citation>Kocher MS, Mandiga R, Zurakowski D, Barnewolt C, Kasser JR. Validation of a clinical prediction rule for the differentiation between septic arthritis and transient synovitis of the hip in children. J Bone Joint Surg Am. 2004 Aug;86(8):1629-35. doi: 10.2106/00004623-200408000-00005.</citation>
      <PMID>15292409</PMID>
    </results_reference>
    <results_reference>
      <citation>Cruz AI Jr, Anari JB, Ramirez JM, Sankar WN, Baldwin KD. Distinguishing Pediatric Lyme Arthritis of the Hip from Transient Synovitis and Acute Bacterial Septic Arthritis: A Systematic Review and Meta-analysis. Cureus. 2018 Jan 25;10(1):e2112. doi: 10.7759/cureus.2112.</citation>
      <PMID>29581924</PMID>
    </results_reference>
    <results_reference>
      <citation>Plumb J, Mallin M, Bolte RG. The role of ultrasound in the emergency department evaluation of the acutely painful pediatric hip. Pediatr Emerg Care. 2015 Jan;31(1):54-8; quiz 59-61. doi: 10.1097/PEC.0000000000000332.</citation>
      <PMID>25560622</PMID>
    </results_reference>
    <results_reference>
      <citation>Laine JC, Denning JR, Riccio AI, Jo C, Joglar JM, Wimberly RL. The use of ultrasound in the management of septic arthritis of the hip. J Pediatr Orthop B. 2015 Mar;24(2):95-8. doi: 10.1097/BPB.0000000000000134.</citation>
      <PMID>25588046</PMID>
    </results_reference>
    <results_reference>
      <citation>Ehrendorfer S, LeQuesne G, Penta M, Smith P, Cundy P. Bilateral synovitis in symptomatic unilateral transient synovitis of the hip: an ultrasonographic study in 56 children. Acta Orthop Scand. 1996 Apr;67(2):149-52. doi: 10.3109/17453679608994660.</citation>
      <PMID>8623569</PMID>
    </results_reference>
    <results_reference>
      <citation>Yabunaka K, Ohue M, Morimoto N, Kitano N, Shinohara K, Takamura M, Gotanda T, Sanada S. Sonographic measurement of transient synovitis in children: diagnostic value of joint effusion. Radiol Phys Technol. 2012 Jan;5(1):15-9. doi: 10.1007/s12194-011-0128-z. Epub 2011 Jul 12.</citation>
      <PMID>21748477</PMID>
    </results_reference>
    <results_reference>
      <citation>Agarwal A, Aggarwal AN. Bone and Joint Infections in Children: Septic Arthritis. Indian J Pediatr. 2016 Aug;83(8):825-33. doi: 10.1007/s12098-015-1816-1. Epub 2015 Jul 21.</citation>
      <PMID>26189923</PMID>
    </results_reference>
    <results_reference>
      <citation>Vieira RL, Levy JA. Bedside ultrasonography to identify hip effusions in pediatric patients. Ann Emerg Med. 2010 Mar;55(3):284-9. doi: 10.1016/j.annemergmed.2009.06.527. Epub 2009 Aug 20.</citation>
      <PMID>19695738</PMID>
    </results_reference>
    <results_reference>
      <citation>Luhmann SJ, Jones A, Schootman M, Gordon JE, Schoenecker PL, Luhmann JD. Differentiation between septic arthritis and transient synovitis of the hip in children with clinical prediction algorithms. J Bone Joint Surg Am. 2004 May;86(5):956-62. doi: 10.2106/00004623-200405000-00011.</citation>
      <PMID>15118038</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Connecticut Children's Medical Center</investigator_affiliation>
      <investigator_full_name>Ruchika Jones</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Point of Care Ultrasound</keyword>
    <keyword>Hip Effusion</keyword>
    <keyword>Pediatric Emergency Medicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis, Infectious</mesh_term>
      <mesh_term>Synovitis</mesh_term>
      <mesh_term>Emergencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Each study site will enter data into Redcap hosted by the lead site, Connecticut Children's. Data will be available for review and combined by Connecticut Children's investigators for data analysis. Each participating site has completed a data use agreement with the lead site agreeing to this plan.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Shared as patients are seen throughout the course of the study.</ipd_time_frame>
      <ipd_access_criteria>Only the designated study investigator at each participating site will have Redcap access for purposes of data entry only. Primary investigators at the lead site will have access to the combined data set for data analyses.</ipd_access_criteria>
    </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/NCT05971745
  org study id: 19-117
  nct id: NCT05971745
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine if pediatric emergency medicine providers can
        accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to
        radiology ultrasound (RADUS).
  The purpose of this study is to determine that the accuracy of trained pediatric emergency
        medicine providers to diagnose hip effusion using point-of-care ultrasound (POCUS) is
        non-inferior to the reference standard of radiology ultrasound (RADUS). Additionally, the
        investigators seek to compare how POCUS performs against other clinical tests or
        investigations for the diagnosis of septic arthritis. The investigators hypothesize that
        trained EM providers will be able to diagnose hip effusions with high (>90%) accuracy
        compared to studies conducted by the Department of Radiology.
  observational model: Other
  time perspective: Prospective
  measure: The presence or absence of a hip effusion.
  time frame: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit through study completion, average of 2 years.
  description: The presence or absence of an effusion as determined by the pediatric emergency medicine physician performing the point-of-care-ultrasound study on both the affected and unaffected sides (i.e. right hip and left hip).
  measure: The presence of absence of a hip effusion.
  time frame: From the time the radiologist reviews the ultrasound as performed by the radiology technician during the emergency department visit, through study completion, average of 2 years.
  description: The presence or absence of an effusion as determined by the Radiologist on both the affected and unaffected sides.
  measure: The size of the effusion.
  time frame: From the time the point-of-care ultrasound is performed by the physician during the emergency department visit to study completion, average of 2 years
  description: As measured by the pediatric emergency medicine provider in millimeters.
  measure: The location of the measurement of the effusion.
  time frame: Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.
  description: Pediatric emergency medicine physicians will measure an effusion at two designated locations. One location is based off of current published literature whereas the second is to provide a comparison to determine if the exact location alters the final diagnosis (effusion or no effusion). Investigators will determine whether the location along the angle of the neck affects the measurement obtained when compared with the current standard practice of measuring fluid along the widest part of the femoral neck.
  measure: Number of point-of-care ultrasound studies performed by PEM providers that have a different final diagnosis when compared to radiology ultrasound.
  time frame: Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.
  description: Investigators will compare the final diagnosis (hip effusion or no hip effusion) between point-of-care-ultrasound and radiology ultrasound to determine the number of discrepancies between the groups.
  measure: Association between negative point-of-care ultrasound and low to moderate Kocher score.
  time frame: Upon chart review: between the time the measurement was obtained in the emergency department up to six weeks later when the chart is reviewed by primary investigator.
  description: Investigators will determine whether the use of ultrasonography in patients with low or moderate Kocher score improves the ability to rule out septic arthritis.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: 18 Years
  healthy volunteers: No
  last name: Ruchika M Jones, MD, MS
  role: Principal Investigator
  affiliation: Connecticut Children's
  last name: Ruchika M Jones, MD, MS
  phone: 860-837-5596
  email: rjones@connecticutchildrens.org
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Australia
  country: United States
  citation: Caird MS, Flynn JM, Leung YL, Millman JE, D'Italia JG, Dormans JP. Factors distinguishing septic arthritis from transient synovitis of the hip in children. A prospective study. J Bone Joint Surg Am. 2006 Jun;88(6):1251-7. doi: 10.2106/JBJS.E.00216.
  PMID: 16757758
  citation: Kocher MS, Zurakowski D, Kasser JR. Differentiating between septic arthritis and transient synovitis of the hip in children: an evidence-based clinical prediction algorithm. J Bone Joint Surg Am. 1999 Dec;81(12):1662-70. doi: 10.2106/00004623-199912000-00002.
  PMID: 10608376
  citation: Klein DM, Barbera C, Gray ST, Spero CR, Perrier G, Teicher JL. Sensitivity of objective parameters in the diagnosis of pediatric septic hips. Clin Orthop Relat Res. 1997 May;(338):153-9. doi: 10.1097/00003086-199705000-00022.
  PMID: 9170376
  citation: Del Beccaro MA, Champoux AN, Bockers T, Mendelman PM. Septic arthritis versus transient synovitis of the hip: the value of screening laboratory tests. Ann Emerg Med. 1992 Dec;21(12):1418-22. doi: 10.1016/s0196-0644(05)80052-6.
  PMID: 1443834
  citation: Fabry G, Meire E. Septic arthritis of the hip in children: poor results after late and inadequate treatment. J Pediatr Orthop. 1983 Sep;3(4):461-6. doi: 10.1097/01241398-198309000-00008.
  PMID: 6630490
  citation: Lunseth PA, Heiple KG. Prognosis in septic arthritis of the hip in children. Clin Orthop Relat Res. 1979 Mar-Apr;(139):81-5.
  PMID: 455855
  citation: Hallel T, Salvati EA. Septic arthritis of the hip in infancy: end result study. Clin Orthop Relat Res. 1978 May;(132):115-28.
  PMID: 307996
  citation: Bennett OM, Namnyak SS. Acute septic arthritis of the hip joint in infancy and childhood. Clin Orthop Relat Res. 1992 Aug;(281):123-32.
  PMID: 1499198
  citation: Kocher MS, Mandiga R, Zurakowski D, Barnewolt C, Kasser JR. Validation of a clinical prediction rule for the differentiation between septic arthritis and transient synovitis of the hip in children. J Bone Joint Surg Am. 2004 Aug;86(8):1629-35. doi: 10.2106/00004623-200408000-00005.
  PMID: 15292409
  citation: Cruz AI Jr, Anari JB, Ramirez JM, Sankar WN, Baldwin KD. Distinguishing Pediatric Lyme Arthritis of the Hip from Transient Synovitis and Acute Bacterial Septic Arthritis: A Systematic Review and Meta-analysis. Cureus. 2018 Jan 25;10(1):e2112. doi: 10.7759/cureus.2112.
  PMID: 29581924
  citation: Plumb J, Mallin M, Bolte RG. The role of ultrasound in the emergency department evaluation of the acutely painful pediatric hip. Pediatr Emerg Care. 2015 Jan;31(1):54-8; quiz 59-61. doi: 10.1097/PEC.0000000000000332.
  PMID: 25560622
  citation: Laine JC, Denning JR, Riccio AI, Jo C, Joglar JM, Wimberly RL. The use of ultrasound in the management of septic arthritis of the hip. J Pediatr Orthop B. 2015 Mar;24(2):95-8. doi: 10.1097/BPB.0000000000000134.
  PMID: 25588046
  citation: Ehrendorfer S, LeQuesne G, Penta M, Smith P, Cundy P. Bilateral synovitis in symptomatic unilateral transient synovitis of the hip: an ultrasonographic study in 56 children. Acta Orthop Scand. 1996 Apr;67(2):149-52. doi: 10.3109/17453679608994660.
  PMID: 8623569
  citation: Yabunaka K, Ohue M, Morimoto N, Kitano N, Shinohara K, Takamura M, Gotanda T, Sanada S. Sonographic measurement of transient synovitis in children: diagnostic value of joint effusion. Radiol Phys Technol. 2012 Jan;5(1):15-9. doi: 10.1007/s12194-011-0128-z. Epub 2011 Jul 12.
  PMID: 21748477
  citation: Agarwal A, Aggarwal AN. Bone and Joint Infections in Children: Septic Arthritis. Indian J Pediatr. 2016 Aug;83(8):825-33. doi: 10.1007/s12098-015-1816-1. Epub 2015 Jul 21.
  PMID: 26189923
  citation: Vieira RL, Levy JA. Bedside ultrasonography to identify hip effusions in pediatric patients. Ann Emerg Med. 2010 Mar;55(3):284-9. doi: 10.1016/j.annemergmed.2009.06.527. Epub 2009 Aug 20.
  PMID: 19695738
  citation: Luhmann SJ, Jones A, Schootman M, Gordon JE, Schoenecker PL, Luhmann JD. Differentiation between septic arthritis and transient synovitis of the hip in children with clinical prediction algorithms. J Bone Joint Surg Am. 2004 May;86(5):956-62. doi: 10.2106/00004623-200405000-00011.
  PMID: 15118038
  responsible party type: Principal Investigator
  investigator affiliation: Connecticut Children's Medical Center
  investigator full name: Ruchika Jones
  investigator title: Principal Investigator
  mesh term: Arthritis, Infectious
  mesh term: Synovitis
  mesh term: Emergencies
  sharing ipd: Yes
  ipd description: Each study site will enter data into Redcap hosted by the lead site, Connecticut Children's. Data will be available for review and combined by Connecticut Children's investigators for data analysis. Each participating site has completed a data use agreement with the lead site agreeing to this plan.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Shared as patients are seen throughout the course of the study.
  ipd access criteria: Only the designated study investigator at each participating site will have Redcap access for purposes of data entry only. Primary investigators at the lead site will have access to the combined data set for data analyses.