<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/NCT03752814</url>
  </required_header>
  <id_info>
    <org_study_id>01-2017</org_study_id>
    <nct_id>NCT03752814</nct_id>
  </id_info>
  <brief_title>SYNOSTE Nitinail System Trial</brief_title>
  <official_title>SYNOSTE Nitinail System Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SYNOSTE Oy</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MVZ Labor Dr. Limbach</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>SYNOSTE Oy</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>
      SYNOSTE Nitinail System Trial is an international multicenter open label single-arm&#xD;
      equivalence study to verify whether the leg-lengthening procedure can be adequately&#xD;
      controlled with the SNS system as measured with the lengthening control index (LCI) at the&#xD;
      end of the distraction period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SYNOSTE Nitinail System (SNS) is an assembly of an active implantable distraction nail&#xD;
      (SYNOSTE Nitinail), Locking screws, accessory instruments for surgery and the home care unit&#xD;
      (also External control unit (ECU) or Halo). It includes also, a software tool, Syndex, that&#xD;
      supports setting up the number of lengthening activations needed per day.&#xD;
&#xD;
      The SNS is intended for lengthening of the femur by distraction osteogenesis.&#xD;
&#xD;
      The study will consist of a recruitment period of 3 months and an observation period of&#xD;
      roughly 24 months (6 months after explantation). The observation period is split in two&#xD;
      parts: The first part contains the most critical treatment phases from implantation surgery&#xD;
      of the device through the actual lengthening phase up to the end of the bone healing. The&#xD;
      second part contains only two visits: the explantation surgery of the device and a control at&#xD;
      6 months of further follow-up.&#xD;
&#xD;
      After the fist part of the trial, a primary analysis of the data including the hypothesis&#xD;
      testing will be carried out. After the second part of the trial a follow-up analysis will be&#xD;
      done.&#xD;
&#xD;
      16 (max 20) patients will be recruited in Finland and Turkey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was stopped due to administrative reasons.&#xD;
  </why_stopped>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Actual">October 10, 2022</completion_date>
  <primary_completion_date type="Actual">October 10, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lengthening control index (LCI)</measure>
    <time_frame>2,5 months</time_frame>
    <description>The primary objective is to verify whether the leg-lengthening procedure can be adequately controlled with the SNS system as measured with the lengthening control index (LCI) at the end of the distraction period defined as LCI = DIachieved / DIscheduled&#xD;
,where DIachieved = Achieved distraction index, ie. the daily rate of distraction has on average occurred during the lengthening phase in mm/d. DIscheduled = mean scheduled lengthening rate in mm/day.&#xD;
Analyzed at primary analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance of Nitinail/Mechanical stability of Nitinail</measure>
    <time_frame>6-9 months</time_frame>
    <description>Mechanical stability of Nitinail as defined by the ratio of the numbers of breakages (nail and screws) to total nails implanted (% and absolute values) at the end of consolidation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance of Nitinail/Nitinail lengthening target achieved (%)</measure>
    <time_frame>2,5 months</time_frame>
    <description>Nitinail lengthening target achieved as defined by % of targeted lengthening achieved by Nitinail determined at the end of lengthening period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance of Nitinail/Nitinail lengthening target achieved (absolute value)</measure>
    <time_frame>2,5 months</time_frame>
    <description>Nitinail lengthening target achieved as defined by absolute value of targeted lengthening achieved by Nitinail determined at the end of lengthening period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance of Nitinail/Translation of nail lengthening to bone lengthening (%)</measure>
    <time_frame>2,5 months</time_frame>
    <description>Translation of nail lengthening to bone lengthening as % of the Bone gap increase from achieved lengthening of Nitinail determined at the end of lengthening period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance of Nitinail/Translation of nail lengthening to bone lengthening (absolute value)</measure>
    <time_frame>2,5 months</time_frame>
    <description>Translation of nail lengthening to bone lengthening as absolute value of the Bone gap increase from achieved lengthening of Nitinail determined at the end of lengthening period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance of Nitinail/Retention of achieved length by Nitinail</measure>
    <time_frame>6-9 months</time_frame>
    <description>Retention of achieved length by Nitinail as change of achieved lengthening of Nitinail between end of distraction and end of consolidation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes/Patient Satisfaction</measure>
    <time_frame>6-9 months AND 24 months</time_frame>
    <description>Patient satisfaction as the overall satisfaction value from Numeric Rating Scale at end of consolidation and final follow-up. The NRS for overall outcomes is a undimensional measure of satisfaction intensity, where the patient selects among 0-10 integers to describe the intensity of their overall satisfaction with the treatment outcomes on a horizontal line. &quot;0&quot; represents completely dissatisfied and &quot;10&quot; fully satisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes/Patient Satisfaction (aesthetic outcomes)</measure>
    <time_frame>6-9 months AND 24 months</time_frame>
    <description>Patient satisfaction as the aesthetic outcomes value from Numeric Rating Scale (NRS) at end of consolidation and final follow-up. The NRS for aesthetic outcomes is a undimensional measure of satisfaction intensity, where the patient selects among 0-10 integers to describe the intensity of their satisfaction with the aesthetic outcomes on a horizontal line. &quot;0&quot; represents completely dissatisfied and &quot;10&quot; fully satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes/Change in scores of 36-Item Short Form Survey (SF-36)</measure>
    <time_frame>6-9 months AND 24 months</time_frame>
    <description>Change in scores of SF-36 from preoperative baseline to end of consolidation for Primary analysis and to last visit for the Follow-up analysis. The used version of the SF-36 is the RAND 36-item health survey 1.0 (1993) with a time frame of 4 weeks. The SF-36 is an established and widely used set of generic, coherent, and easily administered quality-of-life measures in adults. Scoring will be done according to the instructions provided by RAND. Single item scores as well as health concept scale scores range from 0 to 100. A higher score defines a more favorable health state, with a value of 100 representing full health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes/Patient pain status</measure>
    <time_frame>2,5 months</time_frame>
    <description>Patient pain status as change of Numeric Rating Scale (NRS) from preoperative baseline to End of distraction (2,5 months). The NRS for pain is a undimensional measure of pain intensity, where the patient selects among 0-10 integers to describe the intensity of their pain on a horizontal line. &quot;0&quot; represents no pain and &quot;10&quot; worst possible pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes/Patient pain status</measure>
    <time_frame>24 months</time_frame>
    <description>Patient pain status as the pain profile of the Numeric Rating Scale (as described above) during the treatment (until 24 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes/Patient pain status (consumption of pain medication)</measure>
    <time_frame>24 months</time_frame>
    <description>Patient pain status as consumption of pain medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes/Length of sick leave due to treatment</measure>
    <time_frame>6-9 months AND 24 months</time_frame>
    <description>Length of sick leave due treatment in days assessed until the end of consolidation and end of treatment for Primary and Follow-up analyses, respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success of Treatment/Femur lengthening target achieved (%)</measure>
    <time_frame>6-9 months AND 24 months</time_frame>
    <description>Femur lengthening target achieved as % of the achieved femoral length increase of the targeted femoral length increase in mm determined at the end of consolidation and end of treatment for Primary and Follow-up analyses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success of Treatment/Femur lengthening target achieved (absolute value)</measure>
    <time_frame>6-9 months AND 24 months</time_frame>
    <description>Femur lengthening target achieved as absolute value of the achieved femoral length increase of the targeted femoral length increase in mm determined at the end of consolidation and end of treatment for Primary and Follow-up analyses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success of Treatment/Weight bearing index</measure>
    <time_frame>6-9 months</time_frame>
    <description>Weight bearing index as time to final full weight bearing (in days) per the achieved femoral length increase (in cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success of Treatment/Consolidation index</measure>
    <time_frame>6-9 months</time_frame>
    <description>Consolidation index as time to radiological confirmation of 3 cortices bridging the bony gap (in days) per the achieved femoral length increase (in cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Success of Treatment/Knee and hip joint Range of Motion (ROM)</measure>
    <time_frame>6-9 months AND 24 months</time_frame>
    <description>Knee and hip joint Range of Motion (ROM) as flexion and extension at preoperative baseline, End of distraction and End of consolidation and compared to normal population values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nitinail System Safety/Number and type of device related (Serious)Adverse Events</measure>
    <time_frame>(6-9 months AND 24 months)</time_frame>
    <description>Number and type of device related (Serious)Adverse Events reported until the end of consolidation and end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nitinail System Safety/Duration of surgery</measure>
    <time_frame>10 days and 18 months</time_frame>
    <description>Duration of surgery of Nitinail related surgeries from cut-to- closure in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nitinail System Safety/Length of hospital stay</measure>
    <time_frame>10 days and 18 months</time_frame>
    <description>Length of hospital stay of Nitinail related surgeries in days the patient spent in hospital perioperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nitinail System Safety/Patient compliance to lengthening protocol</measure>
    <time_frame>2,5 months</time_frame>
    <description>Patient compliance to lengthening protocol as ratio of lengthening periods with non- compliance to protocol with all lengthening periods with one patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nitinail System Safety/Release of metallic ions from the Nitinail</measure>
    <time_frame>3 months/further monitoring up to 24 months</time_frame>
    <description>Release of metallic ions from the Nitinail as Cobalt and Chromium ion concentrations in blood from preoperative baseline to end of distraction.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Leg Length Inequality</condition>
  <arm_group>
    <arm_group_label>SYNOSTE Nitinail System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intended purpose of the SNS in this trial is lengthening of the femur by callotasis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SYNOSTE Nitinail System</intervention_name>
    <description>Mode of application: 1. Implantation surgery: osteotomy and antegrade implantation of SNS in femur for distraction osteogenesis (callotasis), 2. distraction osteogenesis (implant lengthening phase), 3. Bone healing (implant as stabilizing element during consolidation phase), 4. Explantation after consolidation.</description>
    <arm_group_label>SYNOSTE Nitinail System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for femoral lengthening from different etiologies of max. 70 mm at single&#xD;
             lengthening&#xD;
&#xD;
          -  18 to 65 years regardless of gender&#xD;
&#xD;
          -  Suitable anatomy for SNS&#xD;
&#xD;
          -  Able and willing to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other electronic implants&#xD;
&#xD;
          -  Other Metallic implants in the affected limb below the osteotomy level&#xD;
&#xD;
          -  Need for Magnetic Resonance imaging during the study&#xD;
&#xD;
          -  BMI&gt;30kg/m2 or weight&gt;100kg&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Known hypersensitivity to Co, Ni, Cr or Ti metals&#xD;
&#xD;
          -  Known hypersensitivity to Poly-Ether-Ether-Ketone (PEEK) or Ultrahigh Molecular Weight&#xD;
             Poly-Ethylene (UHMWPE)&#xD;
&#xD;
          -  Open growth plates&#xD;
&#xD;
          -  Malignancy or tumor in bone&#xD;
&#xD;
          -  Osteitis or soft tissue infection&#xD;
&#xD;
          -  Significant existing deficit in range of motion of the adjacent joints&#xD;
&#xD;
          -  Pseudoarthrosis&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Low psychological compliance (e.g. drug abuse)&#xD;
&#xD;
          -  Simultaneous bilateral lengthening&#xD;
&#xD;
          -  Need for osteotomies at multiple levels&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Metin Küçükkaya, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Şişli Florence Nightingale Hospital, Şişli/İstanbul, Turkey</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jan Lindahl, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>HUCH Ortopedics and Traumatology, Töölö Hospital, Finland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HUCH Ortopedics and Traumatology, Töölö Hospital</name>
      <address>
        <city>Helsinki</city>
        <state>Uusimaa</state>
        <zip>00260</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Şişli Florence Nightingale Hospital, Şişli/İstanbul</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>distraction osteogenesis</keyword>
  <keyword>bone lengthening</keyword>
  <keyword>leg length discrepancy</keyword>
  <keyword>callotasis</keyword>
  <keyword>Intramedullary distraction nail</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leg Length Inequality</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03752814
org study id: 01-2017
nct id: NCT03752814
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SYNOSTE Nitinail System Trial is an international multicenter open label single-arm
      equivalence study to verify whether the leg-lengthening procedure can be adequately
      controlled with the SNS system as measured with the lengthening control index (LCI) at the
      end of the distraction period.
The SYNOSTE Nitinail System (SNS) is an assembly of an active implantable distraction nail
      (SYNOSTE Nitinail), Locking screws, accessory instruments for surgery and the home care unit
      (also External control unit (ECU) or Halo). It includes also, a software tool, Syndex, that
      supports setting up the number of lengthening activations needed per day.

      The SNS is intended for lengthening of the femur by distraction osteogenesis.

      The study will consist of a recruitment period of 3 months and an observation period of
      roughly 24 months (6 months after explantation). The observation period is split in two
      parts: The first part contains the most critical treatment phases from implantation surgery
      of the device through the actual lengthening phase up to the end of the bone healing. The
      second part contains only two visits: the explantation surgery of the device and a control at
      6 months of further follow-up.

      After the fist part of the trial, a primary analysis of the data including the hypothesis
      testing will be carried out. After the second part of the trial a follow-up analysis will be
      done.

      16 (max 20) patients will be recruited in Finland and Turkey.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Lengthening control index (LCI)
time frame: 2,5 months
description: The primary objective is to verify whether the leg-lengthening procedure can be adequately controlled with the SNS system as measured with the lengthening control index (LCI) at the end of the distraction period defined as LCI = DIachieved / DIscheduled
,where DIachieved = Achieved distraction index, ie. the daily rate of distraction has on average occurred during the lengthening phase in mm/d. DIscheduled = mean scheduled lengthening rate in mm/day.
Analyzed at primary analysis.
measure: Performance of Nitinail/Mechanical stability of Nitinail
time frame: 6-9 months
description: Mechanical stability of Nitinail as defined by the ratio of the numbers of breakages (nail and screws) to total nails implanted (% and absolute values) at the end of consolidation
measure: Performance of Nitinail/Nitinail lengthening target achieved (%)
time frame: 2,5 months
description: Nitinail lengthening target achieved as defined by % of targeted lengthening achieved by Nitinail determined at the end of lengthening period
measure: Performance of Nitinail/Nitinail lengthening target achieved (absolute value)
time frame: 2,5 months
description: Nitinail lengthening target achieved as defined by absolute value of targeted lengthening achieved by Nitinail determined at the end of lengthening period
measure: Performance of Nitinail/Translation of nail lengthening to bone lengthening (%)
time frame: 2,5 months
description: Translation of nail lengthening to bone lengthening as % of the Bone gap increase from achieved lengthening of Nitinail determined at the end of lengthening period
measure: Performance of Nitinail/Translation of nail lengthening to bone lengthening (absolute value)
time frame: 2,5 months
description: Translation of nail lengthening to bone lengthening as absolute value of the Bone gap increase from achieved lengthening of Nitinail determined at the end of lengthening period
measure: Performance of Nitinail/Retention of achieved length by Nitinail
time frame: 6-9 months
description: Retention of achieved length by Nitinail as change of achieved lengthening of Nitinail between end of distraction and end of consolidation
measure: Patient Reported Outcomes/Patient Satisfaction
time frame: 6-9 months AND 24 months
description: Patient satisfaction as the overall satisfaction value from Numeric Rating Scale at end of consolidation and final follow-up. The NRS for overall outcomes is a undimensional measure of satisfaction intensity, where the patient selects among 0-10 integers to describe the intensity of their overall satisfaction with the treatment outcomes on a horizontal line. "0" represents completely dissatisfied and "10" fully satisfied
measure: Patient Reported Outcomes/Patient Satisfaction (aesthetic outcomes)
time frame: 6-9 months AND 24 months
description: Patient satisfaction as the aesthetic outcomes value from Numeric Rating Scale (NRS) at end of consolidation and final follow-up. The NRS for aesthetic outcomes is a undimensional measure of satisfaction intensity, where the patient selects among 0-10 integers to describe the intensity of their satisfaction with the aesthetic outcomes on a horizontal line. "0" represents completely dissatisfied and "10" fully satisfied.
measure: Patient Reported Outcomes/Change in scores of 36-Item Short Form Survey (SF-36)
time frame: 6-9 months AND 24 months
description: Change in scores of SF-36 from preoperative baseline to end of consolidation for Primary analysis and to last visit for the Follow-up analysis. The used version of the SF-36 is the RAND 36-item health survey 1.0 (1993) with a time frame of 4 weeks. The SF-36 is an established and widely used set of generic, coherent, and easily administered quality-of-life measures in adults. Scoring will be done according to the instructions provided by RAND. Single item scores as well as health concept scale scores range from 0 to 100. A higher score defines a more favorable health state, with a value of 100 representing full health.
measure: Patient Reported Outcomes/Patient pain status
time frame: 2,5 months
description: Patient pain status as change of Numeric Rating Scale (NRS) from preoperative baseline to End of distraction (2,5 months). The NRS for pain is a undimensional measure of pain intensity, where the patient selects among 0-10 integers to describe the intensity of their pain on a horizontal line. "0" represents no pain and "10" worst possible pain.
measure: Patient Reported Outcomes/Patient pain status
time frame: 24 months
description: Patient pain status as the pain profile of the Numeric Rating Scale (as described above) during the treatment (until 24 months)
measure: Patient Reported Outcomes/Patient pain status (consumption of pain medication)
time frame: 24 months
description: Patient pain status as consumption of pain medication
measure: Patient Reported Outcomes/Length of sick leave due to treatment
time frame: 6-9 months AND 24 months
description: Length of sick leave due treatment in days assessed until the end of consolidation and end of treatment for Primary and Follow-up analyses, respectively
measure: Clinical Success of Treatment/Femur lengthening target achieved (%)
time frame: 6-9 months AND 24 months
description: Femur lengthening target achieved as % of the achieved femoral length increase of the targeted femoral length increase in mm determined at the end of consolidation and end of treatment for Primary and Follow-up analyses
measure: Clinical Success of Treatment/Femur lengthening target achieved (absolute value)
time frame: 6-9 months AND 24 months
description: Femur lengthening target achieved as absolute value of the achieved femoral length increase of the targeted femoral length increase in mm determined at the end of consolidation and end of treatment for Primary and Follow-up analyses
measure: Clinical Success of Treatment/Weight bearing index
time frame: 6-9 months
description: Weight bearing index as time to final full weight bearing (in days) per the achieved femoral length increase (in cm)
measure: Clinical Success of Treatment/Consolidation index
time frame: 6-9 months
description: Consolidation index as time to radiological confirmation of 3 cortices bridging the bony gap (in days) per the achieved femoral length increase (in cm)
measure: Clinical Success of Treatment/Knee and hip joint Range of Motion (ROM)
time frame: 6-9 months AND 24 months
description: Knee and hip joint Range of Motion (ROM) as flexion and extension at preoperative baseline, End of distraction and End of consolidation and compared to normal population values
measure: Nitinail System Safety/Number and type of device related (Serious)Adverse Events
time frame: (6-9 months AND 24 months)
description: Number and type of device related (Serious)Adverse Events reported until the end of consolidation and end of treatment.
measure: Nitinail System Safety/Duration of surgery
time frame: 10 days and 18 months
description: Duration of surgery of Nitinail related surgeries from cut-to- closure in minutes
measure: Nitinail System Safety/Length of hospital stay
time frame: 10 days and 18 months
description: Length of hospital stay of Nitinail related surgeries in days the patient spent in hospital perioperatively.
measure: Nitinail System Safety/Patient compliance to lengthening protocol
time frame: 2,5 months
description: Patient compliance to lengthening protocol as ratio of lengthening periods with non- compliance to protocol with all lengthening periods with one patient.
measure: Nitinail System Safety/Release of metallic ions from the Nitinail
time frame: 3 months/further monitoring up to 24 months
description: Release of metallic ions from the Nitinail as Cobalt and Chromium ion concentrations in blood from preoperative baseline to end of distraction.
arm group label: SYNOSTE Nitinail System
arm group type: Experimental
description: The intended purpose of the SNS in this trial is lengthening of the femur by callotasis.
intervention type: Device
intervention name: SYNOSTE Nitinail System
description: Mode of application: 1. Implantation surgery: osteotomy and antegrade implantation of SNS in femur for distraction osteogenesis (callotasis), 2. distraction osteogenesis (implant lengthening phase), 3. Bone healing (implant as stabilizing element during consolidation phase), 4. Explantation after consolidation.
arm group label: SYNOSTE Nitinail System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Metin Küçükkaya, Prof. Dr.
role: Principal Investigator
affiliation: Şişli Florence Nightingale Hospital, Şişli/İstanbul, Turkey
last name: Jan Lindahl, Dr.
role: Principal Investigator
affiliation: HUCH Ortopedics and Traumatology, Töölö Hospital, Finland
facility: 
facility: 
country: Finland
country: Turkey
responsible party type: Sponsor
mesh term: Leg Length Inequality
sharing ipd: No