<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/NCT02260856</url>
  </required_header>
  <id_info>
    <org_study_id>2014-174</org_study_id>
    <nct_id>NCT02260856</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial of Leg Length Discrepancy Techniques</brief_title>
  <official_title>PEDS Trial: Percutaneous Epiphysiodesis, Drill Versus Screws for Leg Length Discrepancy A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hospital for Sick Children</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 is a randomized clinical trial of epiphysiodesis techniques: percutaneous transphyseal&#xD;
      screw epiphysiodesis versus percutaneous drill epiphysiodesis for the correction of leg&#xD;
      length discrepancy. Failed epiphysiodesis was selected as the primary outcome. Failed&#xD;
      epiphysiodesis was defined as one or more of the following: development of angular deformity&#xD;
      &gt; 5°, revision epiphysiodesis, or growth inhibition &lt; 70% of expected. EOS, low dose biplanar&#xD;
      X-Ray, will be used to make all length measurements. Secondary outcomes assess mean growth at&#xD;
      the physis following epiphysiodesis, in the subset of patients with bead implantation,&#xD;
      fluoroscopy and operative times, length of stay, return to full weight bearing, as well as&#xD;
      functional and quality of life outcomes. The following outcome scales will be used to measure&#xD;
      pain (VAS), quality of life (PROMIS Pediatric Pain Interference Scale), and function (PROMIS&#xD;
      Pediatric Mobility Scale, Pedi-FABS, and UCLA Activity Score). Each of these scales has been&#xD;
      validated for use in children (Beyer, Denyes, &amp; Villarruel, 1992; DeWitt et al., 2011;&#xD;
      Fabricant et al., 2013; Novais et al., 2014; Varni et al., 2010a). We will also determine the&#xD;
      cost associated with each technique and perform a cost-effectiveness analysis to establish&#xD;
      which technique is preferred from a societal perspective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drill and screw epiphysiodesis are the two most common techniques for surgical correction of&#xD;
      predicted limb length discrepancies 2-5cm. Both procedures require minimal incisions, less&#xD;
      than 1cm, (Canale &amp; Christian, 1990; Metaizeau et al., 1998). Previous studies have&#xD;
      demonstrated that both drill and screw epiphysiodesis result in improved outcomes compared to&#xD;
      open techniques (Alzahrani, Behairy, Alhossan, Arab, &amp; Alammari, 2003; Canale &amp; Christian,&#xD;
      1990). Moreover, alternative approaches such as medial and lateral 8 plates may not&#xD;
      sufficiently tether growth, or cause peripheral but not central growth arrest (Stewart et&#xD;
      al., 2013). We selected drill vs. screw epiphysiodesis as the two treatment groups as they&#xD;
      are both minimally invasive, relatively effective, in common usage, and are thought to differ&#xD;
      in costs and other characteristics.&#xD;
&#xD;
      Although outcomes of drill and screw epiphysiodesis exist{{10 Campens,C. 2010; 11 Ghanem,I.&#xD;
      2011}} , the assessments are retrospective non-randomized series, which may be at risk for&#xD;
      selection bias, and may not adequately capture all of the outcomes of interest, depending on&#xD;
      what data is routinely collected and documented in the medical chart. To our knowledge, no&#xD;
      prospective randomized comparison of epiphysiodesis techniques and clinical outcomes has been&#xD;
      published accurately assessing how effective each technique is in disabling growth at the&#xD;
      physis, or taking into account patient-centered outcomes or cost. Operative measures such as&#xD;
      the surgical time and radiation exposure from intra-operative fluoroscopy have not previously&#xD;
      been compared. Patient-centered outcomes such as level of pain, activity, and function by&#xD;
      measures such PROMIS and Ped-FABS, have not been previously assessed in this population. The&#xD;
      proposed research study aims to fill this gap.&#xD;
&#xD;
      This study was designed as a multicenter randomized trial to answer an important clinical&#xD;
      question and to do so with a clearly defined objective and validated outcomes. This trial can&#xD;
      be executed on a relatively small budget with simple outcome measures, and recruitment of a&#xD;
      moderate number of patients at each of a few centers well equipped for research. By involving&#xD;
      multiple surgeons and patients from various geographies, we improve the generalizability of&#xD;
      this study. Our institution and collaborating institutions have been successful in completing&#xD;
      randomized clinical trials in the past. This study will answer a clinical question that is&#xD;
      important and current, providing orthopedic surgeons with an evidence-based identification of&#xD;
      the ideal technique for treating predicted limb length discrepancies 2-7cm.&#xD;
&#xD;
      This study will also be the first to accurately measure mean growth following both&#xD;
      epiphysiodesis techniques, through implantation of tantalum beads in consenting participants.&#xD;
      These beads will provide stationary landmarks by which growth can be measured directly, and&#xD;
      not inferred. Previous methods of judging epiphysiodesis success have primarily relied on&#xD;
      assessing efficacy by estimating growth inhibition through calculation. Tantalum beads have&#xD;
      been successfully used in adults and children (Lauge-Pedersen,H. 2006), and although it&#xD;
      requires implantation of small radio-opaque beads, it is considered the gold standard when&#xD;
      making detailed radiographic measures, and the optimal technique for physeal growth&#xD;
      measurements.(Lauge-Pedersen,H. 2006)(Haugan,K. 2012). Over 300 000 beads have been inserted&#xD;
      in vivo without significant complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Failure of Epiphysiodesis</measure>
    <time_frame>2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months</time_frame>
    <description>development of angular deformity &gt; 5°, revision epiphysiodesis, or growth inhibition &lt; 70% of expected</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Physeal Growth</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months</time_frame>
    <description>Distance between tantalum beads.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Baseline Pain</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months</time_frame>
    <description>Visual Analog Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months</time_frame>
    <description>PROMIS Pain Interference and Mobility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>An expected average of 2 days</time_frame>
    <description>participants will be followed for the duration of hospital stay (discharge date - admission date)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to full weight-bearing</measure>
    <time_frame>2- 6 weeks</time_frame>
    <description>Documenting the number of days until patient could weight-bear without using devices as crutches or wheelchairs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for Splint or Cast</measure>
    <time_frame>2- 6 weeks</time_frame>
    <description>Documenting days worn.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days Until Return to Sports</measure>
    <time_frame>2-6 weeks</time_frame>
    <description>Documenting how many days elapsed before the patient returned to sports. This information will be recorded in a post-operative pain and function diary. Return to sports is typically surgeon driven, but timing for return to sports is not standardized in clinical practice. In the current study patients will be allowed to return to sports when pain free, no longer limping and strength is equivalent to the non-operative side</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for Secondary Surgery</measure>
    <time_frame>2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months</time_frame>
    <description>Assessed in follow up clinical visits and documented in clinical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Level</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months</time_frame>
    <description>Pediatric activity scale assessment measured by HSS Pedi-FABS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Level</measure>
    <time_frame>Baseline, 2-6 weeks, 6 months, 12 months, 24 months, and 60 months</time_frame>
    <description>UCLA Activity Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>2-6 weeks, 6 months, 12 months, 24 months, and 60 months</time_frame>
    <description>Complications will be tracked for two years post surgery. Due to previous research, which is outlined below, the following complications will be included in the data collection follow up sheets: angular deformity, revision surgery, time until return to sports, hospital stay, failure/incomplete epiphysiodesis, time until weight bearing, infection, use of aid, number of days using the aid, and osteochondral damage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Costs</measure>
    <time_frame>5 years (end of study)</time_frame>
    <description>Costs will be collected through hospital administration. In hospital costs and outpatients costs will be included. Indirect costs, such as lost days of parental work will not be considered. Only costs from the United States centers in this protocol will be assessed.</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, epiphysiodesis technique, fluoroscopy time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Assessments</measure>
    <time_frame>Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months</time_frame>
    <description>Mechanical Tibial-Femoral Angle, Mechanical Axis Deviation, mLDFA, MPTA, PPTA</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Leg Length Discrepancy</condition>
  <arm_group>
    <arm_group_label>Percutaneous Drill Epiphysiodesis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 5 mm incision will be made centered over the physis both medially and laterally. A 4.5 mm drill will be passed repeatedly across the physis in a divergent manner. Curettes will then be used to further remove and disrupt the growth plate. Fluoroscopy will be used throughout to ensure proper passage of the drill and curettes. Omnipaque dye will then be inserted to confirm ablation of the physis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Percutaneous Screw Epiphysiodesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the distal femur, guide wires will be placed in an antegrade fashion, with an 8 mm skin incision proximal to the physis both medially and laterally. The guide wire will be placed with the medial wire crossing the physis at the junction of the middle and medial third of the physis. The lateral guide wire will cross the physis at the junction of the lateral and middle third of the physis. The wires will extend into the epiphysis, but will not enter the joint. The guide wires will be over drilled with a 5 mm drill, and 7.3 mm fully threaded cannulated screws will be placed across the growth plate. For tibias, screw placement will be retrograde, with 8 mm incisions made medially and laterally distal to the physis, with guide wires aiming proximally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tantalum Beads &amp; Injector</intervention_name>
    <description>To measure growth at physis, four tantalum beads will be implanted per physis at baseline and take radiostereometric analysis measurements at all follow up timepoints. Tantalum beads have been used to make detailed three dimensional radiographic measurements in orthopedic and other specialties</description>
    <arm_group_label>Percutaneous Drill Epiphysiodesis</arm_group_label>
    <arm_group_label>Percutaneous Screw Epiphysiodesis</arm_group_label>
    <other_name>RSA Biomedical.</other_name>
    <other_name>One (1) UmRSA® Injectors Conventional design, Mussle loaded</other_name>
    <other_name>Robust design, Easy to clean and sterilize, Modular design</other_name>
    <other_name>(for Tantalum Markers diameter 0.8 or1.0mm)</other_name>
    <other_name>500 RSA ®Tantalum Markers diameter 0.8mm or 1.0mm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Drill Epiphysiodesis</intervention_name>
    <arm_group_label>Percutaneous Drill Epiphysiodesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Screw Epiphysiodesis</intervention_name>
    <arm_group_label>Percutaneous Screw Epiphysiodesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Open growth plates&#xD;
&#xD;
          -  Skeletally immature requiring isolated complete epiphysiodesis of the distal femur&#xD;
             and/or proximal tibia&#xD;
&#xD;
          -  At least one year of predicted growth remaining&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Predicted limb length discrepancy 2-7 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing additional orthopedic procedures at time of epiphysiodesis&#xD;
&#xD;
          -  Metabolic bone disease or &quot;sick physis&quot; syndrome, that may cause bone to grow in an&#xD;
             unpredictable manner.&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily R Dodwell, MD MPH FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Emily R Dodwell, MD MPH FRCSC</last_name>
    <phone>212-606-1451</phone>
    <email>dodwelle@hss.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kunal N Agarwal, MS</last_name>
    <phone>212-774-2121</phone>
    <email>agarwalk@hss.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Brian Snyder, MD PhD</last_name>
      <phone>617-355-6021</phone>
      <email>Brian.Snyder@childrens.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Benton Heyworth, MD</last_name>
      <phone>617-355-6021</phone>
      <email>Benton.Heyworth@childrens.harvard.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Benton Heyworth, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brian Snyder, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Dodwell, MD MPH FRCSC</last_name>
      <phone>212-606-1451</phone>
      <email>dodwelle@hss.edu</email>
    </contact>
    <contact_backup>
      <last_name>Roger Widmann, MD</last_name>
      <phone>212- 606-1325</phone>
      <email>widmannr@hss.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Emily R Dodwell, MD MPH FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roger F Widmann, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel W Green, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John S Blanco, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shevaun M Doyle, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David M Scher, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jo Hannafin, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Marx, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stephen Lyman, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Douglas Mintz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Martin Gargan, MD FRCSC</last_name>
      <phone>416-813-7980</phone>
      <email>martin.gargan@sickkids.ca</email>
    </contact>
    <investigator>
      <last_name>Martin Gargan, MD FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>James G Wright, MD MPH FRCSC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simon Kelley, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Blair VP 3rd, Walker SJ, Sheridan JJ, Schoenecker PL. Epiphysiodesis: a problem of timing. J Pediatr Orthop. 1982 Aug;2(3):281-4.</citation>
    <PMID>7130384</PMID>
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  <reference>
    <citation>Little DG, Nigo L, Aiona MD. Deficiencies of current methods for the timing of epiphysiodesis. J Pediatr Orthop. 1996 Mar-Apr;16(2):173-9. doi: 10.1097/00004694-199603000-00007.</citation>
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  <reference>
    <citation>Lauge-Pedersen H, Hagglund G, Johnsson R. Radiostereometric analysis for monitoring percutaneous physiodesis. A preliminary study. J Bone Joint Surg Br. 2006 Nov;88(11):1502-7. doi: 10.1302/0301-620X.88B11.17730.</citation>
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  <reference>
    <citation>Haugan K, Husby OS, Klaksvik J, Foss OA. The migration pattern of the Charnley femoral stem: a five-year follow-up RSA study in a well-functioning patient group. J Orthop Traumatol. 2012 Sep;13(3):137-43. doi: 10.1007/s10195-012-0187-x. Epub 2012 May 11.</citation>
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  <reference>
    <citation>Campens C, Mousny M, Docquier PL. Comparison of three surgical epiphysiodesis techniques for the treatment of lower limb length discrepancy. Acta Orthop Belg. 2010 Apr;76(2):226-32.</citation>
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  <reference>
    <citation>Ghanem I, Karam JA, Widmann RF. Surgical epiphysiodesis indications and techniques: update. Curr Opin Pediatr. 2011 Feb;23(1):53-9. doi: 10.1097/MOP.0b013e32834231b3.</citation>
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    <citation>DeWitt EM, Stucky BD, Thissen D, Irwin DE, Langer M, Varni JW, Lai JS, Yeatts KB, Dewalt DA. Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: built using item response theory. J Clin Epidemiol. 2011 Jul;64(7):794-804. doi: 10.1016/j.jclinepi.2010.10.012. Epub 2011 Feb 2.</citation>
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  <reference>
    <citation>Fabricant PD, Robles A, Downey-Zayas T, Do HT, Marx RG, Widmann RF, Green DW. Development and validation of a pediatric sports activity rating scale: the Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS). Am J Sports Med. 2013 Oct;41(10):2421-9. doi: 10.1177/0363546513496548. Epub 2013 Jul 26.</citation>
    <PMID>23893420</PMID>
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  <reference>
    <citation>Novais EN, Heyworth BE, Stamoulis C, Sullivan K, Millis MB, Kim YJ. Open surgical treatment of femoroacetabular impingement in adolescent athletes: preliminary report on improvement of physical activity level. J Pediatr Orthop. 2014 Apr-May;34(3):287-94. doi: 10.1097/BPO.0000000000000093.</citation>
    <PMID>24172673</PMID>
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  <reference>
    <citation>Varni JW, Thissen D, Stucky BD, Liu Y, Magnus B, Quinn H, Irwin DE, DeWitt EM, Lai JS, Amtmann D, Gross HE, DeWalt DA. PROMIS(R) Parent Proxy Report Scales for children ages 5-7 years: an item response theory analysis of differential item functioning across age groups. Qual Life Res. 2014 Feb;23(1):349-61. doi: 10.1007/s11136-013-0439-0. Epub 2013 Jun 6.</citation>
    <PMID>23740167</PMID>
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  <reference>
    <citation>Canale ST, Christian CA. Techniques for epiphysiodesis about the knee. Clin Orthop Relat Res. 1990 Jun;(255):81-5.</citation>
    <PMID>2347169</PMID>
  </reference>
  <reference>
    <citation>Metaizeau JP, Wong-Chung J, Bertrand H, Pasquier P. Percutaneous epiphysiodesis using transphyseal screws (PETS). J Pediatr Orthop. 1998 May-Jun;18(3):363-9.</citation>
    <PMID>9600565</PMID>
  </reference>
  <reference>
    <citation>Stewart D, Cheema A, Szalay EA. Dual 8-plate technique is not as effective as ablation for epiphysiodesis about the knee. J Pediatr Orthop. 2013 Dec;33(8):843-6. doi: 10.1097/BPO.0b013e3182a11d23.</citation>
    <PMID>23872800</PMID>
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  <reference>
    <citation>Alzahrani AG, Behairy YM, Alhossan MH, Arab FS, Alammari AA. Percutaneous versus open epiphysiodesis. Saudi Med J. 2003 Feb;24(2):203-5.</citation>
    <PMID>12682689</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RCT</keyword>
  <keyword>Epiphysiodesis</keyword>
  <keyword>Tantalum beads</keyword>
  <keyword>Patient centered outcome data</keyword>
  <keyword>Cost effective analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leg Length Inequality</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/NCT02260856
org study id: 2014-174
nct id: NCT02260856
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is a randomized clinical trial of epiphysiodesis techniques: percutaneous transphyseal
      screw epiphysiodesis versus percutaneous drill epiphysiodesis for the correction of leg
      length discrepancy. Failed epiphysiodesis was selected as the primary outcome. Failed
      epiphysiodesis was defined as one or more of the following: development of angular deformity
      > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected. EOS, low dose biplanar
      X-Ray, will be used to make all length measurements. Secondary outcomes assess mean growth at
      the physis following epiphysiodesis, in the subset of patients with bead implantation,
      fluoroscopy and operative times, length of stay, return to full weight bearing, as well as
      functional and quality of life outcomes. The following outcome scales will be used to measure
      pain (VAS), quality of life (PROMIS Pediatric Pain Interference Scale), and function (PROMIS
      Pediatric Mobility Scale, Pedi-FABS, and UCLA Activity Score). Each of these scales has been
      validated for use in children (Beyer, Denyes, & Villarruel, 1992; DeWitt et al., 2011;
      Fabricant et al., 2013; Novais et al., 2014; Varni et al., 2010a). We will also determine the
      cost associated with each technique and perform a cost-effectiveness analysis to establish
      which technique is preferred from a societal perspective.
Drill and screw epiphysiodesis are the two most common techniques for surgical correction of
      predicted limb length discrepancies 2-5cm. Both procedures require minimal incisions, less
      than 1cm, (Canale & Christian, 1990; Metaizeau et al., 1998). Previous studies have
      demonstrated that both drill and screw epiphysiodesis result in improved outcomes compared to
      open techniques (Alzahrani, Behairy, Alhossan, Arab, & Alammari, 2003; Canale & Christian,
      1990). Moreover, alternative approaches such as medial and lateral 8 plates may not
      sufficiently tether growth, or cause peripheral but not central growth arrest (Stewart et
      al., 2013). We selected drill vs. screw epiphysiodesis as the two treatment groups as they
      are both minimally invasive, relatively effective, in common usage, and are thought to differ
      in costs and other characteristics.

      Although outcomes of drill and screw epiphysiodesis exist{{10 Campens,C. 2010; 11 Ghanem,I.
      2011}} , the assessments are retrospective non-randomized series, which may be at risk for
      selection bias, and may not adequately capture all of the outcomes of interest, depending on
      what data is routinely collected and documented in the medical chart. To our knowledge, no
      prospective randomized comparison of epiphysiodesis techniques and clinical outcomes has been
      published accurately assessing how effective each technique is in disabling growth at the
      physis, or taking into account patient-centered outcomes or cost. Operative measures such as
      the surgical time and radiation exposure from intra-operative fluoroscopy have not previously
      been compared. Patient-centered outcomes such as level of pain, activity, and function by
      measures such PROMIS and Ped-FABS, have not been previously assessed in this population. The
      proposed research study aims to fill this gap.

      This study was designed as a multicenter randomized trial to answer an important clinical
      question and to do so with a clearly defined objective and validated outcomes. This trial can
      be executed on a relatively small budget with simple outcome measures, and recruitment of a
      moderate 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 identification of
      the ideal technique for treating predicted limb length discrepancies 2-7cm.

      This study will also be the first to accurately measure mean growth following both
      epiphysiodesis techniques, through implantation of tantalum beads in consenting participants.
      These beads will provide stationary landmarks by which growth can be measured directly, and
      not inferred. Previous methods of judging epiphysiodesis success have primarily relied on
      assessing efficacy by estimating growth inhibition through calculation. Tantalum beads have
      been successfully used in adults and children (Lauge-Pedersen,H. 2006), and although it
      requires implantation of small radio-opaque beads, it is considered the gold standard when
      making detailed radiographic measures, and the optimal technique for physeal growth
      measurements.(Lauge-Pedersen,H. 2006)(Haugan,K. 2012). Over 300 000 beads have been inserted
      in vivo without significant complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Failure of Epiphysiodesis
time frame: 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
description: development of angular deformity > 5°, revision epiphysiodesis, or growth inhibition < 70% of expected
measure: Change in Physeal Growth
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
description: Distance between tantalum beads.
measure: Time to Baseline Pain
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
description: Visual Analog Scale
measure: Quality of Life
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
description: PROMIS Pain Interference and Mobility
measure: Length of Hospital Stay
time frame: An expected average of 2 days
description: participants will be followed for the duration of hospital stay (discharge date - admission date)
measure: Time to full weight-bearing
time frame: 2- 6 weeks
description: Documenting the number of days until patient could weight-bear without using devices as crutches or wheelchairs.
measure: Need for Splint or Cast
time frame: 2- 6 weeks
description: Documenting days worn.
measure: Days Until Return to Sports
time frame: 2-6 weeks
description: Documenting how many days elapsed before the patient returned to sports. This information will be recorded in a post-operative pain and function diary. Return to sports is typically surgeon driven, but timing for return to sports is not standardized in clinical practice. In the current study patients will be allowed to return to sports when pain free, no longer limping and strength is equivalent to the non-operative side
measure: Need for Secondary Surgery
time frame: 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
description: Assessed in follow up clinical visits and documented in clinical records
measure: Physical Activity Level
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
description: Pediatric activity scale assessment measured by HSS Pedi-FABS.
measure: Physical Activity Level
time frame: Baseline, 2-6 weeks, 6 months, 12 months, 24 months, and 60 months
description: UCLA Activity Scale
measure: Complications
time frame: 2-6 weeks, 6 months, 12 months, 24 months, and 60 months
description: Complications will be tracked for two years post surgery. Due to previous research, which is outlined below, the following complications will be included in the data collection follow up sheets: angular deformity, revision surgery, time until return to sports, hospital stay, failure/incomplete epiphysiodesis, time until weight bearing, infection, use of aid, number of days using the aid, and osteochondral damage.
measure: Medical Costs
time frame: 5 years (end of study)
description: Costs will be collected through hospital administration. In hospital costs and outpatients costs will be included. Indirect costs, such as lost days of parental work will not be considered. Only costs from the United States centers in this protocol will be assessed.
measure: Operative Outcomes
time frame: intra-operative
description: radiation, total time during surgery, skin dose, blood loss, surgeon experience, epiphysiodesis technique, fluoroscopy time
measure: Radiographic Assessments
time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months, 23-25 months, 59-61 months
description: Mechanical Tibial-Femoral Angle, Mechanical Axis Deviation, mLDFA, MPTA, PPTA
arm group label: Percutaneous Drill Epiphysiodesis
arm group type: Active Comparator
description: A 5 mm incision will be made centered over the physis both medially and laterally. A 4.5 mm drill will be passed repeatedly across the physis in a divergent manner. Curettes will then be used to further remove and disrupt the growth plate. Fluoroscopy will be used throughout to ensure proper passage of the drill and curettes. Omnipaque dye will then be inserted to confirm ablation of the physis.
arm group label: Percutaneous Screw Epiphysiodesis
arm group type: Experimental
description: In the distal femur, guide wires will be placed in an antegrade fashion, with an 8 mm skin incision proximal to the physis both medially and laterally. The guide wire will be placed with the medial wire crossing the physis at the junction of the middle and medial third of the physis. The lateral guide wire will cross the physis at the junction of the lateral and middle third of the physis. The wires will extend into the epiphysis, but will not enter the joint. The guide wires will be over drilled with a 5 mm drill, and 7.3 mm fully threaded cannulated screws will be placed across the growth plate. For tibias, screw placement will be retrograde, with 8 mm incisions made medially and laterally distal to the physis, with guide wires aiming proximally.
intervention type: Device
intervention name: Tantalum Beads & Injector
description: To measure growth at physis, four tantalum beads will be implanted per physis at baseline and take radiostereometric analysis measurements at all follow up timepoints. Tantalum beads have been used to make detailed three dimensional radiographic measurements in orthopedic and other specialties
arm group label: Percutaneous Drill Epiphysiodesis
arm group label: Percutaneous Screw Epiphysiodesis
other name: RSA Biomedical.
other name: One (1) UmRSA® Injectors Conventional design, Mussle loaded
other name: Robust design, Easy to clean and sterilize, Modular design
other name: (for Tantalum Markers diameter 0.8 or1.0mm)
other name: 500 RSA ®Tantalum Markers diameter 0.8mm or 1.0mm
intervention type: Procedure
intervention name: Percutaneous Drill Epiphysiodesis
arm group label: Percutaneous Drill Epiphysiodesis
intervention type: Procedure
intervention name: Percutaneous Screw Epiphysiodesis
arm group label: Percutaneous Screw Epiphysiodesis
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: No
last name: Emily R Dodwell, MD MPH FRCSC
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
last name: Emily R Dodwell, MD MPH FRCSC
phone: 212-606-1451
email: dodwelle@hss.edu
last name: Kunal N Agarwal, MS
phone: 212-774-2121
email: agarwalk@hss.edu
facility: 
status: Not yet recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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status: Not yet recruiting
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country: Canada
country: United States
citation: Blair VP 3rd, Walker SJ, Sheridan JJ, Schoenecker PL. Epiphysiodesis: a problem of timing. J Pediatr Orthop. 1982 Aug;2(3):281-4.
PMID: 7130384
citation: Little DG, Nigo L, Aiona MD. Deficiencies of current methods for the timing of epiphysiodesis. J Pediatr Orthop. 1996 Mar-Apr;16(2):173-9. doi: 10.1097/00004694-199603000-00007.
PMID: 8742279
citation: Lauge-Pedersen H, Hagglund G, Johnsson R. Radiostereometric analysis for monitoring percutaneous physiodesis. A preliminary study. J Bone Joint Surg Br. 2006 Nov;88(11):1502-7. doi: 10.1302/0301-620X.88B11.17730.
PMID: 17075098
citation: Haugan K, Husby OS, Klaksvik J, Foss OA. The migration pattern of the Charnley femoral stem: a five-year follow-up RSA study in a well-functioning patient group. J Orthop Traumatol. 2012 Sep;13(3):137-43. doi: 10.1007/s10195-012-0187-x. Epub 2012 May 11.
PMID: 22576838
citation: Campens C, Mousny M, Docquier PL. Comparison of three surgical epiphysiodesis techniques for the treatment of lower limb length discrepancy. Acta Orthop Belg. 2010 Apr;76(2):226-32.
PMID: 20503949
citation: Ghanem I, Karam JA, Widmann RF. Surgical epiphysiodesis indications and techniques: update. Curr Opin Pediatr. 2011 Feb;23(1):53-9. doi: 10.1097/MOP.0b013e32834231b3.
PMID: 21169837
citation: DeWitt EM, Stucky BD, Thissen D, Irwin DE, Langer M, Varni JW, Lai JS, Yeatts KB, Dewalt DA. Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: built using item response theory. J Clin Epidemiol. 2011 Jul;64(7):794-804. doi: 10.1016/j.jclinepi.2010.10.012. Epub 2011 Feb 2.
PMID: 21292444
citation: Fabricant PD, Robles A, Downey-Zayas T, Do HT, Marx RG, Widmann RF, Green DW. Development and validation of a pediatric sports activity rating scale: the Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS). Am J Sports Med. 2013 Oct;41(10):2421-9. doi: 10.1177/0363546513496548. Epub 2013 Jul 26.
PMID: 23893420
citation: Novais EN, Heyworth BE, Stamoulis C, Sullivan K, Millis MB, Kim YJ. Open surgical treatment of femoroacetabular impingement in adolescent athletes: preliminary report on improvement of physical activity level. J Pediatr Orthop. 2014 Apr-May;34(3):287-94. doi: 10.1097/BPO.0000000000000093.
PMID: 24172673
citation: Varni JW, Thissen D, Stucky BD, Liu Y, Magnus B, Quinn H, Irwin DE, DeWitt EM, Lai JS, Amtmann D, Gross HE, DeWalt DA. PROMIS(R) Parent Proxy Report Scales for children ages 5-7 years: an item response theory analysis of differential item functioning across age groups. Qual Life Res. 2014 Feb;23(1):349-61. doi: 10.1007/s11136-013-0439-0. Epub 2013 Jun 6.
PMID: 23740167
citation: Canale ST, Christian CA. Techniques for epiphysiodesis about the knee. Clin Orthop Relat Res. 1990 Jun;(255):81-5.
PMID: 2347169
citation: Metaizeau JP, Wong-Chung J, Bertrand H, Pasquier P. Percutaneous epiphysiodesis using transphyseal screws (PETS). J Pediatr Orthop. 1998 May-Jun;18(3):363-9.
PMID: 9600565
citation: Stewart D, Cheema A, Szalay EA. Dual 8-plate technique is not as effective as ablation for epiphysiodesis about the knee. J Pediatr Orthop. 2013 Dec;33(8):843-6. doi: 10.1097/BPO.0b013e3182a11d23.
PMID: 23872800
citation: Alzahrani AG, Behairy YM, Alhossan MH, Arab FS, Alammari AA. Percutaneous versus open epiphysiodesis. Saudi Med J. 2003 Feb;24(2):203-5.
PMID: 12682689
responsible party type: Sponsor
mesh term: Leg Length Inequality