<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/NCT03275805</url>
  </required_header>
  <id_info>
    <org_study_id>20-3104</org_study_id>
    <nct_id>NCT03275805</nct_id>
  </id_info>
  <brief_title>Should Graf IIc Hips be Treated for 12 Weeks</brief_title>
  <official_title>How Should Stable Graf Type IIc Hips be Treated With Pavlik Harness?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</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>
      Children who are diagnosed with Developmental Hip Dysplasia (DDH) are often categorized&#xD;
      depending on the severity of their hip malformation. Regardless of the severity, the accepted&#xD;
      form of treatment is the Pavlik Harness. Unfortunately, there is no specific recommended&#xD;
      treatment regarding length of Pavlik Harness treatment for patients with DDH who have who&#xD;
      have been categorized with stable Graf type IIc hips. The investigators will aim to answer&#xD;
      this question with a randomized controlled trial of patients with these specific findings by&#xD;
      dividing selected patients into 2 arms. Each arm consists of varying lengths of Pavlik&#xD;
      harness treatment (treatment to normalization, no less than 6 weeks or 12 weeks full-time).&#xD;
      Patient's two year follow up radiographs will determine the best means of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Developmental Dysplasia of the Hip is a thoroughly researched and manageable disease if&#xD;
      treated correctly. While the literature agrees that Pavlik Harness treatment is the best&#xD;
      means of treatment, there is still a lack of research regarding those patients who have&#xD;
      stable Graf type IIc hips. Graf's classification method outlines the severity of dysplasia&#xD;
      with a categorical method based on physical exam and ultrasound findings with a range of I-IV&#xD;
      given in increasing order of severity. There are recommendations for how to treat more severe&#xD;
      forms, but there is no consensus among orthopedic surgeons on how to specifically treat type&#xD;
      IIc hips who present with stable hips.&#xD;
&#xD;
      Patients ages (0-18 weeks) of age will be recruited who present with stable Graf type IIc&#xD;
      hips that have normal exam and abnormal ultrasound. The investigator's designated hip clinic&#xD;
      defines normal exam as Ortolani and Barlow negative hips. Alpha angle will be used to&#xD;
      determine normalcy on ultrasound. Abnormal ultrasound will be defined as an alpha angle &lt;60&#xD;
      degrees, and less than 50% coverage and is justification in the facility for entrance into&#xD;
      our designated hip protocol.&#xD;
&#xD;
      Upon meeting inclusion/exclusion criteria, patients diagnosed with IIc hips will be placed in&#xD;
      the harness around 6 weeks of age. Patient consents will ensue at their 6 week follow up and&#xD;
      will randomly divide patients into one of two arms: one control group which will receive the&#xD;
      standard 12 week full-time protocol for Pavlik Harness treatment used at the institution, and&#xD;
      one experimental group which will receive full-time Pavlik Harness treatment until&#xD;
      normalization, but for no less than 6 weeks. All patients will be required to follow up at&#xD;
      week 1, 2, 3, 4, 6, 8, 10, and 12, then at 6 months, one year, and two years from the time of&#xD;
      harness placement. Ultrasounds will take place at week 1, 2, 3, 4, 6, 8, 10 and 12 and 6&#xD;
      months; radiographs will be taken at patients 6 month, one year and two year follow ups due&#xD;
      to ossification of the femoral head. Acetabular Index (AI) at two-year radiographs will be&#xD;
      used as the primary outcome variable.&#xD;
&#xD;
      Patients in the 6 week arm will only cease treatment if ultrasound and physical exam findings&#xD;
      are acceptable. If patients fail to have acceptable ultrasound findings at 6 weeks, then the&#xD;
      associated complication/failure will be noted, patients will be ineligible for study&#xD;
      inclusion, and will continue with treatment to ensure hip reduction.&#xD;
&#xD;
      At routine follow ups, providers will note patient alpha angles on ultrasound at weeks&#xD;
      1,2,3,4,6, 8, 10, and 12 weeks. Since infant hips mature and may not be as visible on&#xD;
      ultrasound around 6 months of age, acetabular indices on radiographs will be taken to measure&#xD;
      patient hips at 6 month, 1 year, and 2 year follow ups. These images will be analyzed from&#xD;
      within EPIC after patient visits and data information will be stored in RedCAP until the&#xD;
      remainder of the study. Demographic and clinical characteristics will be included through&#xD;
      descriptive statistics. Non-inferiority testing between patient's 2 year AI findings will&#xD;
      determine if 6 weeks of treatment is no less harmful in terms of incidences of residual&#xD;
      dysplasia to that of 12 weeks of treatment. The specified non-inferiority margin will be 4&#xD;
      degrees. This is the chosen clinically accepted difference in AI between groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 11, 2021</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acetabular Index at 2 years</measure>
    <time_frame>2 year follow up</time_frame>
    <description>AI is a categorical measure that can be calculated on routine radiographs (X-rays). This measure helps clinicians get an overall view of the patient hip morphology and illustrates the effectiveness of Pavlik treatment by revealing the placement of the femoral head within the acetabulum (hip socket). AI is expressed as a horizontal line connecting Hilgenreiner's line to another line connecting the acetabular roofs.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Cost of Treatment</measure>
    <time_frame>After conclusion of the 2 year follow up</time_frame>
    <description>Patient charges for both arms will be collected and compared (physician, imaging, facility charges)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Developmental Dysplasia of Hip</condition>
  <arm_group>
    <arm_group_label>12 weeks Pavlik Treatment Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will receive 12 weeks of full-time Pavlik Harness treatment. Patients will most likely begin the 12-week regiment at their first visit to our hip clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 weeks Pavlik Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive treatment to normalization, but for no less than 6 weeks. Patients will begin their treatment around the time of their first visit to our designated hip clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Duration of Pavlik Harness treatment</intervention_name>
    <description>The only intervention that varies from standard of care (12 weeks of treatment) will be the duration of bracing (for the treatment to normalization arm). Patients in both arms will have identical follow up protocols and imaging to closely monitor hip morphology.</description>
    <arm_group_label>6 weeks Pavlik Treatment Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>12 week standard of care</intervention_name>
    <description>The intervention for this arm will be standard treatment for this pathology.</description>
    <arm_group_label>12 weeks Pavlik Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patients with:&#xD;
&#xD;
          -  DDH&#xD;
&#xD;
          -  Graf IIc hips (alpha angle = 43-49 degrees)&#xD;
&#xD;
          -  normal hip exam (stable hips)&#xD;
&#xD;
          -  abnormal ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with additional conditions: Neurologic or teratologic.&#xD;
&#xD;
          2. Follow up that occurs at any other institution.&#xD;
&#xD;
          3. Unstable hips&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Weeks</minimum_age>
    <maximum_age>18 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gaia Georgopoulos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Colorado</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reba L Salton, BS</last_name>
    <phone>7207770702</phone>
    <email>reba.salton@childrenscolorado.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gaia Georgopoulos, MD</last_name>
    <phone>7207775571</phone>
    <email>gaia.georgopoulos@childrenscolorado.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Reba L Salton</last_name>
      <phone>720-777-0702</phone>
      <email>reba.salton@childrenscolorado.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bialik V, Bialik GM, Blazer S, Sujov P, Wiener F, Berant M. Developmental dysplasia of the hip: a new approach to incidence. Pediatrics. 1999 Jan;103(1):93-9. doi: 10.1542/peds.103.1.93.</citation>
    <PMID>9917445</PMID>
  </reference>
  <reference>
    <citation>Dunn PM, Evans RE, Thearle MJ, Griffiths HE, Witherow PJ. Congenital dislocation of the hip: early and late diagnosis and management compared. Arch Dis Child. 1985 May;60(5):407-14. doi: 10.1136/adc.60.5.407.</citation>
    <PMID>4015144</PMID>
  </reference>
  <reference>
    <citation>Harding MG, Harcke HT, Bowen JR, Guille JT, Glutting J. Management of dislocated hips with Pavlik harness treatment and ultrasound monitoring. J Pediatr Orthop. 1997 Mar-Apr;17(2):189-98. doi: 10.1097/00004694-199703000-00010.</citation>
    <PMID>9075094</PMID>
  </reference>
  <reference>
    <citation>Herring JA. Conservative treatment of congenital dislocation of the hip in the newborn and infant. Clin Orthop Relat Res. 1992 Aug;(281):41-7.</citation>
    <PMID>1499226</PMID>
  </reference>
  <reference>
    <citation>Lorente Molto FJ, Gregori AM, Casas LM, Perales VM. Three-year prospective study of developmental dysplasia of the hip at birth: should all dislocated or dislocatable hips be treated? J Pediatr Orthop. 2002 Sep-Oct;22(5):613-21.</citation>
    <PMID>12198463</PMID>
  </reference>
  <reference>
    <citation>Mubarak S, Garfin S, Vance R, McKinnon B, Sutherland D. Pitfalls in the use of the Pavlik harness for treatment of congenital dysplasia, subluxation, and dislocation of the hip. J Bone Joint Surg Am. 1981 Oct;63(8):1239-48.</citation>
    <PMID>7287794</PMID>
  </reference>
  <reference>
    <citation>Novais EN, Sanders J, Kestel LA, Carry PM, Meyers ML. Graf Type-IV Hips Have a Higher Risk of Residual Acetabular Dysplasia at 1 Year of Age Following Successful Pavlik Harness Treatment for Developmental Hip Dysplasia. J Pediatr Orthop. 2018 Nov/Dec;38(10):498-502. doi: 10.1097/BPO.0000000000000875.</citation>
    <PMID>27662383</PMID>
  </reference>
  <reference>
    <citation>Paton RW, Hopgood PJ, Eccles K. Instability of the neonatal hip: the role of early or late splintage. Int Orthop. 2004 Oct;28(5):270-3. doi: 10.1007/s00264-004-0576-8. Epub 2004 Aug 12.</citation>
    <PMID>15309324</PMID>
  </reference>
  <reference>
    <citation>Rosendahl K, Dezateux C, Fosse KR, Aase H, Aukland SM, Reigstad H, Alsaker T, Moster D, Lie RT, Markestad T. Immediate treatment versus sonographic surveillance for mild hip dysplasia in newborns. Pediatrics. 2010 Jan;125(1):e9-16. doi: 10.1542/peds.2009-0357. Epub 2009 Dec 21.</citation>
    <PMID>20026501</PMID>
  </reference>
  <reference>
    <citation>Sewell MD, Rosendahl K, Eastwood DM. Developmental dysplasia of the hip. BMJ. 2009 Nov 24;339:b4454. doi: 10.1136/bmj.b4454. No abstract available.</citation>
    <PMID>19934187</PMID>
  </reference>
  <reference>
    <citation>Takahashi I. Functional treatment of congenital dislocation of the hip using Pavlik harness (Riemenbugel). Nihon Seikeigeka Gakkai Zasshi. 1985 Nov;59(11):973-84.</citation>
    <PMID>3831166</PMID>
  </reference>
  <reference>
    <citation>Westacott DJ, Mackay ND, Waton A, Webb MS, Henman P, Cooke SJ. Staged weaning versus immediate cessation of Pavlik harness treatment for developmental dysplasia of the hip. J Pediatr Orthop B. 2014 Mar;23(2):103-6. doi: 10.1097/BPB.0000000000000025.</citation>
    <PMID>24322535</PMID>
  </reference>
  <reference>
    <citation>Wood MK, Conboy V, Benson MK. Does early treatment by abduction splintage improve the development of dysplastic but stable neonatal hips? J Pediatr Orthop. 2000 May-Jun;20(3):302-5.</citation>
    <PMID>10823594</PMID>
  </reference>
  <reference>
    <citation>Atalar H, Sayli U, Yavuz OY, Uras I, Dogruel H. Indicators of successful use of the Pavlik harness in infants with developmental dysplasia of the hip. Int Orthop. 2007 Apr;31(2):145-50. doi: 10.1007/s00264-006-0097-8. Epub 2006 Apr 7.</citation>
    <PMID>16601983</PMID>
  </reference>
  <reference>
    <citation>Viere RG, Birch JG, Herring JA, Roach JW, Johnston CE. Use of the Pavlik harness in congenital dislocation of the hip. An analysis of failures of treatment. J Bone Joint Surg Am. 1990 Feb;72(2):238-44.</citation>
    <PMID>2303510</PMID>
  </reference>
  <reference>
    <citation>Lerman JA, Emans JB, Millis MB, Share J, Zurakowski D, Kasser JR. Early failure of Pavlik harness treatment for developmental hip dysplasia: clinical and ultrasound predictors. J Pediatr Orthop. 2001 May-Jun;21(3):348-53.</citation>
    <PMID>11371819</PMID>
  </reference>
  <reference>
    <citation>Graf R. Classification of hip joint dysplasia by means of sonography. Arch Orthop Trauma Surg (1978). 1984;102(4):248-55. doi: 10.1007/BF00436138.</citation>
    <PMID>6712426</PMID>
  </reference>
  <reference>
    <citation>Shorter D, Hong T, Osborn DA. Cochrane Review: Screening programmes for developmental dysplasia of the hip in newborn infants. Evid Based Child Health. 2013 Jan;8(1):11-54. doi: 10.1002/ebch.1891.</citation>
    <PMID>23878122</PMID>
  </reference>
  <reference>
    <citation>Woolacott NF, Puhan MA, Steurer J, Kleijnen J. Ultrasonography in screening for developmental dysplasia of the hip in newborns: systematic review. BMJ. 2005 Jun 18;330(7505):1413. doi: 10.1136/bmj.38450.646088.E0. Epub 2005 Jun 1.</citation>
    <PMID>15930025</PMID>
  </reference>
  <reference>
    <citation>Bracken J, Tran T, Ditchfield M. Developmental dysplasia of the hip: controversies and current concepts. J Paediatr Child Health. 2012 Nov;48(11):963-72; quiz 972-3. doi: 10.1111/j.1440-1754.2012.02601.x.</citation>
    <PMID>23126391</PMID>
  </reference>
  <reference>
    <citation>Shipman SA, Helfand M, Moyer VA, Yawn BP. Screening for developmental dysplasia of the hip: a systematic literature review for the US Preventive Services Task Force. Pediatrics. 2006 Mar;117(3):e557-76. doi: 10.1542/peds.2005-1597.</citation>
    <PMID>16510634</PMID>
  </reference>
  <reference>
    <citation>Patel H; Canadian Task Force on Preventive Health Care. Preventive health care, 2001 update: screening and management of developmental dysplasia of the hip in newborns. CMAJ. 2001 Jun 12;164(12):1669-77.</citation>
    <PMID>11450209</PMID>
  </reference>
  <reference>
    <citation>Godley DR. Assessment, diagnosis, and treatment of developmental dysplasia of the hip. JAAPA. 2013 Mar;26(3):54-8. doi: 10.1097/01720610-201303000-00011. No abstract available.</citation>
    <PMID>23520807</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DDH</keyword>
  <keyword>Pavlik Harness</keyword>
  <keyword>dysplasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Developmental Dysplasia of the Hip</mesh_term>
    <mesh_term>Hip Dislocation, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No sharing. Data is in RedCAP and will only be available for listed authors.</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/NCT03275805
org study id: 20-3104
nct id: NCT03275805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children who are diagnosed with Developmental Hip Dysplasia (DDH) are often categorized
      depending on the severity of their hip malformation. Regardless of the severity, the accepted
      form of treatment is the Pavlik Harness. Unfortunately, there is no specific recommended
      treatment regarding length of Pavlik Harness treatment for patients with DDH who have who
      have been categorized with stable Graf type IIc hips. The investigators will aim to answer
      this question with a randomized controlled trial of patients with these specific findings by
      dividing selected patients into 2 arms. Each arm consists of varying lengths of Pavlik
      harness treatment (treatment to normalization, no less than 6 weeks or 12 weeks full-time).
      Patient's two year follow up radiographs will determine the best means of treatment.
Developmental Dysplasia of the Hip is a thoroughly researched and manageable disease if
      treated correctly. While the literature agrees that Pavlik Harness treatment is the best
      means of treatment, there is still a lack of research regarding those patients who have
      stable Graf type IIc hips. Graf's classification method outlines the severity of dysplasia
      with a categorical method based on physical exam and ultrasound findings with a range of I-IV
      given in increasing order of severity. There are recommendations for how to treat more severe
      forms, but there is no consensus among orthopedic surgeons on how to specifically treat type
      IIc hips who present with stable hips.

      Patients ages (0-18 weeks) of age will be recruited who present with stable Graf type IIc
      hips that have normal exam and abnormal ultrasound. The investigator's designated hip clinic
      defines normal exam as Ortolani and Barlow negative hips. Alpha angle will be used to
      determine normalcy on ultrasound. Abnormal ultrasound will be defined as an alpha angle <60
      degrees, and less than 50% coverage and is justification in the facility for entrance into
      our designated hip protocol.

      Upon meeting inclusion/exclusion criteria, patients diagnosed with IIc hips will be placed in
      the harness around 6 weeks of age. Patient consents will ensue at their 6 week follow up and
      will randomly divide patients into one of two arms: one control group which will receive the
      standard 12 week full-time protocol for Pavlik Harness treatment used at the institution, and
      one experimental group which will receive full-time Pavlik Harness treatment until
      normalization, but for no less than 6 weeks. All patients will be required to follow up at
      week 1, 2, 3, 4, 6, 8, 10, and 12, then at 6 months, one year, and two years from the time of
      harness placement. Ultrasounds will take place at week 1, 2, 3, 4, 6, 8, 10 and 12 and 6
      months; radiographs will be taken at patients 6 month, one year and two year follow ups due
      to ossification of the femoral head. Acetabular Index (AI) at two-year radiographs will be
      used as the primary outcome variable.

      Patients in the 6 week arm will only cease treatment if ultrasound and physical exam findings
      are acceptable. If patients fail to have acceptable ultrasound findings at 6 weeks, then the
      associated complication/failure will be noted, patients will be ineligible for study
      inclusion, and will continue with treatment to ensure hip reduction.

      At routine follow ups, providers will note patient alpha angles on ultrasound at weeks
      1,2,3,4,6, 8, 10, and 12 weeks. Since infant hips mature and may not be as visible on
      ultrasound around 6 months of age, acetabular indices on radiographs will be taken to measure
      patient hips at 6 month, 1 year, and 2 year follow ups. These images will be analyzed from
      within EPIC after patient visits and data information will be stored in RedCAP until the
      remainder of the study. Demographic and clinical characteristics will be included through
      descriptive statistics. Non-inferiority testing between patient's 2 year AI findings will
      determine if 6 weeks of treatment is no less harmful in terms of incidences of residual
      dysplasia to that of 12 weeks of treatment. The specified non-inferiority margin will be 4
      degrees. This is the chosen clinically accepted difference in AI between groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acetabular Index at 2 years
time frame: 2 year follow up
description: AI is a categorical measure that can be calculated on routine radiographs (X-rays). This measure helps clinicians get an overall view of the patient hip morphology and illustrates the effectiveness of Pavlik treatment by revealing the placement of the femoral head within the acetabulum (hip socket). AI is expressed as a horizontal line connecting Hilgenreiner's line to another line connecting the acetabular roofs.
measure: Cost of Treatment
time frame: After conclusion of the 2 year follow up
description: Patient charges for both arms will be collected and compared (physician, imaging, facility charges)
arm group label: 12 weeks Pavlik Treatment Arm
arm group type: Active Comparator
description: This arm will receive 12 weeks of full-time Pavlik Harness treatment. Patients will most likely begin the 12-week regiment at their first visit to our hip clinic.
arm group label: 6 weeks Pavlik Treatment Arm
arm group type: Experimental
description: This arm will receive treatment to normalization, but for no less than 6 weeks. Patients will begin their treatment around the time of their first visit to our designated hip clinic.
intervention type: Other
intervention name: Duration of Pavlik Harness treatment
description: The only intervention that varies from standard of care (12 weeks of treatment) will be the duration of bracing (for the treatment to normalization arm). Patients in both arms will have identical follow up protocols and imaging to closely monitor hip morphology.
arm group label: 6 weeks Pavlik Treatment Arm
intervention type: Other
intervention name: 12 week standard of care
description: The intervention for this arm will be standard treatment for this pathology.
arm group label: 12 weeks Pavlik Treatment Arm
criteria: 
gender: All
minimum age: 0 Weeks
maximum age: 18 Weeks
healthy volunteers: No
last name: Gaia Georgopoulos, MD
role: Principal Investigator
affiliation: Children's Hospital Colorado
last name: Reba L Salton, BS
phone: 7207770702
email: reba.salton@childrenscolorado.org
last name: Gaia Georgopoulos, MD
phone: 7207775571
email: gaia.georgopoulos@childrenscolorado.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Bialik V, Bialik GM, Blazer S, Sujov P, Wiener F, Berant M. Developmental dysplasia of the hip: a new approach to incidence. Pediatrics. 1999 Jan;103(1):93-9. doi: 10.1542/peds.103.1.93.
PMID: 9917445
citation: Dunn PM, Evans RE, Thearle MJ, Griffiths HE, Witherow PJ. Congenital dislocation of the hip: early and late diagnosis and management compared. Arch Dis Child. 1985 May;60(5):407-14. doi: 10.1136/adc.60.5.407.
PMID: 4015144
citation: Harding MG, Harcke HT, Bowen JR, Guille JT, Glutting J. Management of dislocated hips with Pavlik harness treatment and ultrasound monitoring. J Pediatr Orthop. 1997 Mar-Apr;17(2):189-98. doi: 10.1097/00004694-199703000-00010.
PMID: 9075094
citation: Herring JA. Conservative treatment of congenital dislocation of the hip in the newborn and infant. Clin Orthop Relat Res. 1992 Aug;(281):41-7.
PMID: 1499226
citation: Lorente Molto FJ, Gregori AM, Casas LM, Perales VM. Three-year prospective study of developmental dysplasia of the hip at birth: should all dislocated or dislocatable hips be treated? J Pediatr Orthop. 2002 Sep-Oct;22(5):613-21.
PMID: 12198463
citation: Mubarak S, Garfin S, Vance R, McKinnon B, Sutherland D. Pitfalls in the use of the Pavlik harness for treatment of congenital dysplasia, subluxation, and dislocation of the hip. J Bone Joint Surg Am. 1981 Oct;63(8):1239-48.
PMID: 7287794
citation: Novais EN, Sanders J, Kestel LA, Carry PM, Meyers ML. Graf Type-IV Hips Have a Higher Risk of Residual Acetabular Dysplasia at 1 Year of Age Following Successful Pavlik Harness Treatment for Developmental Hip Dysplasia. J Pediatr Orthop. 2018 Nov/Dec;38(10):498-502. doi: 10.1097/BPO.0000000000000875.
PMID: 27662383
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responsible party type: Sponsor
mesh term: Developmental Dysplasia of the Hip
mesh term: Hip Dislocation, Congenital
sharing ipd: No
ipd description: No sharing. Data is in RedCAP and will only be available for listed authors.