<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/NCT02259140</url>
  </required_header>
  <id_info>
    <org_study_id>2014-199</org_study_id>
    <nct_id>NCT02259140</nct_id>
  </id_info>
  <brief_title>A Randomized Control Trial of Hip Dislocation Techniques for Pediatric Patients With Cerebral Palsy</brief_title>
  <official_title>ORCHID: Osteotomy vs Resection in CP Hip for Irreducible Dislocations: A Randomized Controlled Trial Comparing McHale to Castle Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Phoenix Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>British Columbia Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nicklaus Children's Hospital f/k/a Miami Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial will compare proximal femoral resection-interposition&#xD;
      arthroplasty to proximal femoral resection with subtrochanteric valgus osteotomy for the&#xD;
      treatment of painful irreducible hip dislocation in patients with cerebral palsy. The primary&#xD;
      outcome is quality of life and care giver burden measured by The Caregiver Priorities and&#xD;
      Child Health Index of Life with Disabilities (CPCHILD) score at one year. Secondary outcomes&#xD;
      will include pain (NCCPC-R, PROMIS pain intensity and PROMIS pain interference), function&#xD;
      (mobility questions), complications and surgical parameters such as OR time and fluoroscopy&#xD;
      time. A cost-effectiveness analysis will follow completion of the randomized controlled trial&#xD;
      (RCT). The authors hypothesize that mean CPCHILD scores (measured at 1 year) will be&#xD;
      significantly higher following the Subtrochanteric Valgus Osteotomy technique compared to&#xD;
      Proximal Femoral Resection-Interposition Arthroplasty technique. Furthermore, the Proximal&#xD;
      Femoral Resection-Interposition Arthroplasty technique will have a shorter length of hospital&#xD;
      stay, shorter fluoroscopy and OR times and the Subtrochanteric Valgus Osteotomy will have&#xD;
      longer sitting tolerance, less pain, smaller burden for caregivers, better health, and higher&#xD;
      quality of life. Additionally the authors hypothesize that Subtrochanteric Valgus Osteotomy&#xD;
      will be more expensive than Proximal Femoral Resection-Interposition Arthroplasty, due to the&#xD;
      cost of the plate, longer operative time, longer length of stay, and blood loss, but&#xD;
      Subtrochanteric Valgus Osteotomy will be preferred by patients due to less pain and better&#xD;
      functional and quality of life outcomes.The results of this study are expected to improve&#xD;
      outcomes for children with cerebral palsy with painful irreducible dislocated hips.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of children with cerebral palsy (CP) with painful dislocated hips is a clinical&#xD;
      challenge for the pediatric orthopedic surgeon. Although current regimens are based primarily&#xD;
      on hip surveillance and early treatment of subluxation to avoid progression to dislocation,&#xD;
      hip dislocations are still identified in the CP population. In younger children, in whom the&#xD;
      hip is still of relatively normal morphology with intact cartilage and potential for&#xD;
      remodeling (often identified by open tri-radiate cartilage) open hip reduction, varus&#xD;
      rotational osteotomy and pelvic osteotomy may be a reasonable option. In older children,&#xD;
      those with a deformed or damaged femoral head, those with closed triradiate cartilage, or in&#xD;
      those with an irreducible hip, salvage options must be considered.&#xD;
&#xD;
      Multiple techniques exist for treatment of irreducible painful hips in CP, including proximal&#xD;
      femoral resection-interposition arthroplasty, resection at the femoral neck with&#xD;
      subtrochanteric valgus osteotomy, hip replacement or hip arthrodesis (fusing the femur to the&#xD;
      socket in a static position). This wide variation in practices is consistent with clinical&#xD;
      uncertainty regarding the optimal treatment method for this problem. The most frequently&#xD;
      performed intervention for a painful irreducible hip in the setting of CP is a form of&#xD;
      resection arthroplasty, either alone (proximal femoral resection-interposition arthroplasty)&#xD;
      or in conjunction with valgus support osteotomy. Technique selection is based on the&#xD;
      functional level of the patient, patient symptoms, and surgeon preference.{{257 Van Riet,A.&#xD;
      2009; 253 Wright,P.B. 2013}}&#xD;
&#xD;
      Although outcomes of resection at the femoral neck with subtrochanteric valgus osteotomy and&#xD;
      proximal femoral resection-interposition arthroplasty techniques exist, published reports are&#xD;
      retrospective non-randomized small series, which may be at risk for selection bias, and do&#xD;
      not adequately capture all of the outcomes of interest, depending on what data has been&#xD;
      routinely collected and documented in the medical chart.{{253 Wright,P.B. 2013; 259 Leet,A.I.&#xD;
      2005}},{{252 Boldingh,E.J. 2013}} Furthermore, results from these studies may be influenced&#xD;
      by confounding factors, such as differences in patient age and other inequalities between&#xD;
      groups at the time of surgery.{{252 Boldingh,E.J. 2013; 253 Wright,P.B. 2013; 277&#xD;
      Settecerri,J.J. 2000}} To the investigators knowledge, no prospective randomized comparison&#xD;
      of hip resection techniques has been published accurately assessing child and parent quality&#xD;
      of life, hip migration, or taking into account sitting and standing tolerance, pain, or&#xD;
      hospital length of stay. Operative measures such as surgical time, blood loss and radiation&#xD;
      exposure from intra-operative fluoroscopy have not previously been compared in a prospective&#xD;
      manner.&#xD;
&#xD;
      This study was designed as a multicenter randomized trial to answer an important clinical&#xD;
      question about a rare condition, and to do so with a clearly defined objective and validated&#xD;
      set of outcomes. This simple trial can be executed on a relatively small budget with simple&#xD;
      outcome measures, and recruitment of a small number of patients at each of a few centers well&#xD;
      equipped for research. By involving multiple surgeons and patients from various geographies,&#xD;
      we improve the generalizability of this study. Our institution and collaborating institutions&#xD;
      have been successful in completing randomized clinical trials in the past. This study will&#xD;
      answer a clinical question that is important and current, providing orthopedic surgeons with&#xD;
      an evidence-based answer: the optimal technique in treating painful irreducible hip&#xD;
      dislocation in patients with cerebral palsy. The proposed research study aims to fill these&#xD;
      gaps.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No patients have been enrolled since 2015. There has been difficulty recruiting patients for&#xD;
    randomization. We have initiated a prospective cohort study evaluating salvage hip procedures&#xD;
    for patients with cerebral palsy.&#xD;
  </why_stopped>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">May 13, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Life and Caregiver Burden</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>Measured by CPCHILD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Hip Migration</measure>
    <time_frame>Baseline, post-operative, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>X-rays measuring hip migration will be standardized to anteroposterior (AP) Pelvis and Frog lateral. Patient positioning will be standardized according to normal clinical practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>NCCPC-R, PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>Indirect Cost Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>An expected average of 5 days</time_frame>
    <description>Discharge date - admission date. Transform into number of days. Length of stay can vary from days to weeks, if serious complication occurs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sitting Tolerance</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>Measured by wheelchair pressure mapping (hours /wk)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>Measured by goniometer (degrees)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>Infection, deep vein thrombosis (DVT), fracture, heterotropic calcification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>Measured by GMFCS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Splint</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>Need for splint or cast will be documented in medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Surgery</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>Need for secondary surgery will be documented in medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standing Tolerance</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months</time_frame>
    <description>Measured by instander (hours/ week)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Costs</measure>
    <time_frame>4 years (end of study)</time_frame>
    <description>analyze claims data (approx 4 years)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative Outcomes</measure>
    <time_frame>intra-operative</time_frame>
    <description>radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hip Dysplasia</condition>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Proximal Femoral Resection Arthroplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 10-12 cm direct lateral incision will be made distally from the greater trochanter. The abductors of the hip are detached with sharp dissection. A capsulotomy is performed. The femur is exposed in a supra-periosteal manner (2 cm distal to the lesser trochanter) at the level of the ischium; transverse osteotomy will then be performed. The joint capsule will be sutured to itself. The iliopsoas tendon and the abductor tendons are attached to the capsule. The quadriceps will be brought around the proximal femoral stump and sutured to medial tissues.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subtrochanteric Valgus Osteotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 10-12 cm direct lateral incision will be made distally from the greater trochanter. The medial half of the abductors may be incised off the greater trochanter for repair. The femoral head is resected at the base of the neck. The ligamentum teres is incised off the head and preserved. A lateral closing wedge osteotomy is performed below the lesser trochanter. 3.5 or 4.5 5 hole locking/non-locking surgeon-contoured plate ( 45⁰) will be used to stabilize the osteotomy. Femoral torsion will be corrected. The psoas tendon will attach the ligamentum teres to the lesser trochanter. The anterior and posterior capsule is sutured together creating interposition tissue. If the ligamentum teres was sutured to the lesser trochanter, the capsule will not close, but will be covered by the psoas tendon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Proximal Femoral Resection Arthroplasty</intervention_name>
    <description>Drains will be placed at the surgeon's discretion. Patients will be placed in skin traction on the operative side. Post-operative bracing or casting will be at the surgeon's discretion. All patients will receive standardized post-operative prophylactic radiation to minimize heterotopic ossification.</description>
    <arm_group_label>Proximal Femoral Resection Arthroplasty</arm_group_label>
    <other_name>Castle Technique</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subtrochanteric Valgus Osteotomy</intervention_name>
    <description>Drains will be placed at the surgeon's discretion. Post-operative bracing or casting will be at the surgeon's discretion. All patients will receive standardized post-operative prophylactic radiation to minimize heterotopic ossification.</description>
    <arm_group_label>Subtrochanteric Valgus Osteotomy</arm_group_label>
    <other_name>McHale Technique</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  7-21 years of age&#xD;
&#xD;
          -  Painful irreducible Hip dislocation and cerebral palsy diagnosis&#xD;
&#xD;
          -  GMFCS 4 or 5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  GMFCS 1-3&#xD;
&#xD;
          -  Decline to participate&#xD;
&#xD;
          -  Outcome scales not validated in patient language.&#xD;
&#xD;
          -  Candidate for total hip replacement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily Dodwell, MD MPH FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Children's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Van Riet A, Moens P. The McHale procedure in the treatment of the painful chronically dislocated hip in adolescents and adults with cerebral palsy. Acta Orthop Belg. 2009 Apr;75(2):181-8.</citation>
    <PMID>19492557</PMID>
  </reference>
  <reference>
    <citation>Wright PB, Ruder J, Birnbaum MA, Phillips JH, Herrera-Soto JA, Knapp DR. Outcomes after salvage procedures for the painful dislocated hip in cerebral palsy. J Pediatr Orthop. 2013 Jul-Aug;33(5):505-10. doi: 10.1097/BPO.0b013e3182924677.</citation>
    <PMID>23752147</PMID>
  </reference>
  <reference>
    <citation>Leet AI, Chhor K, Launay F, Kier-York J, Sponseller PD. Femoral head resection for painful hip subluxation in cerebral palsy: Is valgus osteotomy in conjunction with femoral head resection preferable to proximal femoral head resection and traction? J Pediatr Orthop. 2005 Jan-Feb;25(1):70-3. doi: 10.1097/00004694-200501000-00016.</citation>
    <PMID>15614063</PMID>
  </reference>
  <reference>
    <citation>Boldingh EJ, Bouwhuis CB, van der Heijden-Maessen HC, Bos CF, Lankhorst GJ. Palliative hip surgery in severe cerebral palsy: a systematic review. J Pediatr Orthop B. 2014 Jan;23(1):86-92. doi: 10.1097/BPB.0b013e3283651a5d.</citation>
    <PMID>24025529</PMID>
  </reference>
  <reference>
    <citation>Settecerri JJ, Karol LA. Effectiveness of femoral varus osteotomy in patients with cerebral palsy. J Pediatr Orthop. 2000 Nov-Dec;20(6):776-80. doi: 10.1097/00004694-200011000-00015.</citation>
    <PMID>11097253</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>May 13, 2021</last_update_submitted>
  <last_update_submitted_qc>May 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cerebral palsy</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>hip dislocation</keyword>
  <keyword>hip subluxation</keyword>
  <keyword>patient centered outcomes</keyword>
  <keyword>cost effectiveness analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Hip Dislocation</mesh_term>
    <mesh_term>Developmental Dysplasia of the Hip</mesh_term>
    <mesh_term>Hip Dislocation, Congenital</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <!-- 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/NCT02259140
org study id: 2014-199
nct id: NCT02259140
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This randomized controlled trial will compare proximal femoral resection-interposition
      arthroplasty to proximal femoral resection with subtrochanteric valgus osteotomy for the
      treatment of painful irreducible hip dislocation in patients with cerebral palsy. The primary
      outcome is quality of life and care giver burden measured by The Caregiver Priorities and
      Child Health Index of Life with Disabilities (CPCHILD) score at one year. Secondary outcomes
      will include pain (NCCPC-R, PROMIS pain intensity and PROMIS pain interference), function
      (mobility questions), complications and surgical parameters such as OR time and fluoroscopy
      time. A cost-effectiveness analysis will follow completion of the randomized controlled trial
      (RCT). The authors hypothesize that mean CPCHILD scores (measured at 1 year) will be
      significantly higher following the Subtrochanteric Valgus Osteotomy technique compared to
      Proximal Femoral Resection-Interposition Arthroplasty technique. Furthermore, the Proximal
      Femoral Resection-Interposition Arthroplasty technique will have a shorter length of hospital
      stay, shorter fluoroscopy and OR times and the Subtrochanteric Valgus Osteotomy will have
      longer sitting tolerance, less pain, smaller burden for caregivers, better health, and higher
      quality of life. Additionally the authors hypothesize that Subtrochanteric Valgus Osteotomy
      will be more expensive than Proximal Femoral Resection-Interposition Arthroplasty, due to the
      cost of the plate, longer operative time, longer length of stay, and blood loss, but
      Subtrochanteric Valgus Osteotomy will be preferred by patients due to less pain and better
      functional and quality of life outcomes.The results of this study are expected to improve
      outcomes for children with cerebral palsy with painful irreducible dislocated hips.
The treatment of children with cerebral palsy (CP) with painful dislocated hips is a clinical
      challenge for the pediatric orthopedic surgeon. Although current regimens are based primarily
      on hip surveillance and early treatment of subluxation to avoid progression to dislocation,
      hip dislocations are still identified in the CP population. In younger children, in whom the
      hip is still of relatively normal morphology with intact cartilage and potential for
      remodeling (often identified by open tri-radiate cartilage) open hip reduction, varus
      rotational osteotomy and pelvic osteotomy may be a reasonable option. In older children,
      those with a deformed or damaged femoral head, those with closed triradiate cartilage, or in
      those with an irreducible hip, salvage options must be considered.

      Multiple techniques exist for treatment of irreducible painful hips in CP, including proximal
      femoral resection-interposition arthroplasty, resection at the femoral neck with
      subtrochanteric valgus osteotomy, hip replacement or hip arthrodesis (fusing the femur to the
      socket in a static position). This wide variation in practices is consistent with clinical
      uncertainty regarding the optimal treatment method for this problem. The most frequently
      performed intervention for a painful irreducible hip in the setting of CP is a form of
      resection arthroplasty, either alone (proximal femoral resection-interposition arthroplasty)
      or in conjunction with valgus support osteotomy. Technique selection is based on the
      functional level of the patient, patient symptoms, and surgeon preference.{{257 Van Riet,A.
      2009; 253 Wright,P.B. 2013}}

      Although outcomes of resection at the femoral neck with subtrochanteric valgus osteotomy and
      proximal femoral resection-interposition arthroplasty techniques exist, published reports are
      retrospective non-randomized small series, which may be at risk for selection bias, and do
      not adequately capture all of the outcomes of interest, depending on what data has been
      routinely collected and documented in the medical chart.{{253 Wright,P.B. 2013; 259 Leet,A.I.
      2005}},{{252 Boldingh,E.J. 2013}} Furthermore, results from these studies may be influenced
      by confounding factors, such as differences in patient age and other inequalities between
      groups at the time of surgery.{{252 Boldingh,E.J. 2013; 253 Wright,P.B. 2013; 277
      Settecerri,J.J. 2000}} To the investigators knowledge, no prospective randomized comparison
      of hip resection techniques has been published accurately assessing child and parent quality
      of life, hip migration, or taking into account sitting and standing tolerance, pain, or
      hospital length of stay. Operative measures such as surgical time, blood loss and radiation
      exposure from intra-operative fluoroscopy have not previously been compared in a prospective
      manner.

      This study was designed as a multicenter randomized trial to answer an important clinical
      question about a rare condition, and to do so with a clearly defined objective and validated
      set of outcomes. This simple trial can be executed on a relatively small budget with simple
      outcome measures, and recruitment of a small number of patients at each of a few centers well
      equipped for research. By involving multiple surgeons and patients from various geographies,
      we improve the generalizability of this study. Our institution and collaborating institutions
      have been successful in completing randomized clinical trials in the past. This study will
      answer a clinical question that is important and current, providing orthopedic surgeons with
      an evidence-based answer: the optimal technique in treating painful irreducible hip
      dislocation in patients with cerebral palsy. The proposed research study aims to fill these
      gaps.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in Quality of Life and Caregiver Burden
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: Measured by CPCHILD.
measure: Mean Hip Migration
time frame: Baseline, post-operative, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: X-rays measuring hip migration will be standardized to anteroposterior (AP) Pelvis and Frog lateral. Patient positioning will be standardized according to normal clinical practice.
measure: Pain Scores
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: NCCPC-R, PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity
measure: Caregiver Burden
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: Indirect Cost Form
measure: Length of Stay
time frame: An expected average of 5 days
description: Discharge date - admission date. Transform into number of days. Length of stay can vary from days to weeks, if serious complication occurs.
measure: Sitting Tolerance
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: Measured by wheelchair pressure mapping (hours /wk)
measure: Range of Motion
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: Measured by goniometer (degrees)
measure: Complications
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: Infection, deep vein thrombosis (DVT), fracture, heterotropic calcification
measure: Function
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: Measured by GMFCS.
measure: Splint
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: Need for splint or cast will be documented in medical records.
measure: Secondary Surgery
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: Need for secondary surgery will be documented in medical records.
measure: Standing Tolerance
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
description: Measured by instander (hours/ week)
measure: Medical Costs
time frame: 4 years (end of study)
description: analyze claims data (approx 4 years)
measure: Operative Outcomes
time frame: intra-operative
description: radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique
arm group label: Proximal Femoral Resection Arthroplasty
arm group type: Active Comparator
description: A 10-12 cm direct lateral incision will be made distally from the greater trochanter. The abductors of the hip are detached with sharp dissection. A capsulotomy is performed. The femur is exposed in a supra-periosteal manner (2 cm distal to the lesser trochanter) at the level of the ischium; transverse osteotomy will then be performed. The joint capsule will be sutured to itself. The iliopsoas tendon and the abductor tendons are attached to the capsule. The quadriceps will be brought around the proximal femoral stump and sutured to medial tissues.
arm group label: Subtrochanteric Valgus Osteotomy
arm group type: Experimental
description: A 10-12 cm direct lateral incision will be made distally from the greater trochanter. The medial half of the abductors may be incised off the greater trochanter for repair. The femoral head is resected at the base of the neck. The ligamentum teres is incised off the head and preserved. A lateral closing wedge osteotomy is performed below the lesser trochanter. 3.5 or 4.5 5 hole locking/non-locking surgeon-contoured plate ( 45⁰) will be used to stabilize the osteotomy. Femoral torsion will be corrected. The psoas tendon will attach the ligamentum teres to the lesser trochanter. The anterior and posterior capsule is sutured together creating interposition tissue. If the ligamentum teres was sutured to the lesser trochanter, the capsule will not close, but will be covered by the psoas tendon.
intervention type: Procedure
intervention name: Proximal Femoral Resection Arthroplasty
description: Drains will be placed at the surgeon's discretion. Patients will be placed in skin traction on the operative side. Post-operative bracing or casting will be at the surgeon's discretion. All patients will receive standardized post-operative prophylactic radiation to minimize heterotopic ossification.
arm group label: Proximal Femoral Resection Arthroplasty
other name: Castle Technique
intervention type: Procedure
intervention name: Subtrochanteric Valgus Osteotomy
description: Drains will be placed at the surgeon's discretion. Post-operative bracing or casting will be at the surgeon's discretion. All patients will receive standardized post-operative prophylactic radiation to minimize heterotopic ossification.
arm group label: Subtrochanteric Valgus Osteotomy
other name: McHale Technique
criteria: 
gender: All
minimum age: 7 Years
maximum age: 21 Years
healthy volunteers: No
last name: Emily Dodwell, MD MPH FRCSC
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
facility: 
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country: Canada
country: United States
citation: Van Riet A, Moens P. The McHale procedure in the treatment of the painful chronically dislocated hip in adolescents and adults with cerebral palsy. Acta Orthop Belg. 2009 Apr;75(2):181-8.
PMID: 19492557
citation: Wright PB, Ruder J, Birnbaum MA, Phillips JH, Herrera-Soto JA, Knapp DR. Outcomes after salvage procedures for the painful dislocated hip in cerebral palsy. J Pediatr Orthop. 2013 Jul-Aug;33(5):505-10. doi: 10.1097/BPO.0b013e3182924677.
PMID: 23752147
citation: Leet AI, Chhor K, Launay F, Kier-York J, Sponseller PD. Femoral head resection for painful hip subluxation in cerebral palsy: Is valgus osteotomy in conjunction with femoral head resection preferable to proximal femoral head resection and traction? J Pediatr Orthop. 2005 Jan-Feb;25(1):70-3. doi: 10.1097/00004694-200501000-00016.
PMID: 15614063
citation: Boldingh EJ, Bouwhuis CB, van der Heijden-Maessen HC, Bos CF, Lankhorst GJ. Palliative hip surgery in severe cerebral palsy: a systematic review. J Pediatr Orthop B. 2014 Jan;23(1):86-92. doi: 10.1097/BPB.0b013e3283651a5d.
PMID: 24025529
citation: Settecerri JJ, Karol LA. Effectiveness of femoral varus osteotomy in patients with cerebral palsy. J Pediatr Orthop. 2000 Nov-Dec;20(6):776-80. doi: 10.1097/00004694-200011000-00015.
PMID: 11097253
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Hip Dislocation
mesh term: Developmental Dysplasia of the Hip
mesh term: Hip Dislocation, Congenital
mesh term: Cerebral Palsy