<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/NCT03262844</url>
  </required_header>
  <id_info>
    <org_study_id>CZ1702TCS</org_study_id>
    <nct_id>NCT03262844</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome</brief_title>
  <official_title>Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome: A Conservative Treatment- Controlled, Randomized, Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Changzheng Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Changzheng Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a&#xD;
      series of neurological dysfunctions and deformities attributable to abnormally increased&#xD;
      tension on the spinal cord, which is lacking effective treatment to relieve the symptoms and&#xD;
      prevent progression. Dr. Shi recently proposed a new technique as nerve root axial&#xD;
      decompression surgery, which is also called capsule surgery, to treat patients with TCS. Yet,&#xD;
      the effectiveness and safety should be further studied.&#xD;
&#xD;
      Purpose: The aim of this study is to compare the effectiveness and safety of clinical&#xD;
      outcomes between capsule surgery and conservative treatment in patients with TCS. A study&#xD;
      hypothesis is that outcomes will be improved after capsule surgery.&#xD;
&#xD;
      Methods: This study is a randomized clinical trial with a two-factor (2x7) research design.&#xD;
      The TCS patients will be randomly assigned in one of the two treatment groups: capsule&#xD;
      surgery and conservative treatment. Seven outcome measures will be collected pre-operative&#xD;
      for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits,&#xD;
      including: International Consultation on Incontinence Modular Questionnaire Short Version&#xD;
      (ICI-Q-SF), Rintala Score, a new developed Chinese version of questionnaire, Oswestry&#xD;
      disability index (ODI), SF-12, foot function index (FFI) and Pirani score. Urodynamic&#xD;
      testing, bladder ultrasonography, electromyogram, muscle strength and sensation of lower&#xD;
      limbs will be obtained before and post treatment, to determine the patient's function of&#xD;
      lower limbs. The investigator performing the outcome measures will be blinded to group&#xD;
      assignment, and therefore will not participate in treatment. After randomization, the&#xD;
      conservative group will be followed up in the outpatient clinic. The capsule surgery group&#xD;
      will receive the nerve root axial decompression surgery (capsule surgery).&#xD;
&#xD;
      Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences&#xD;
      in the seven measures between groups and at the five different time frames with the α level&#xD;
      set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the&#xD;
      differences in the urodynamics and muscle strength data over time and between groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a&#xD;
      series of neurological dysfunctions and deformities attributable to abnormally increased&#xD;
      tension on the spinal cord. The standard surgical treatment is untethering the spinal cord&#xD;
      and correction of the related deformity. Although reported results are encouraging, it&#xD;
      continues to pose challenges on management of TCS patients. Symptomatic re-tethering seems to&#xD;
      be an inevitable result, which occurs in 20%-50% patients after untethering. Recently, filum&#xD;
      dissection was found no good to improve urinary symptoms compared to conservative treatment&#xD;
      in teenagers as reported in an RCT study. Also, it remained controversy when to perform the&#xD;
      surgery and how to evaluate the benefits of surgery or conservative treatment. Dr. Shi&#xD;
      recently proposed a new technique as nerve root axial decompression surgery, which is also&#xD;
      called capsule surgery, to treat patients with TCS. Yet, the effectiveness and safety should&#xD;
      be further studied.&#xD;
&#xD;
      Purpose: The aim of this study is to compare the effectiveness and safety of clinical&#xD;
      outcomes between capsule surgery and conservative treatment in patients with TCS. A study&#xD;
      hypothesis is that outcomes will be improved after capsule surgery.&#xD;
&#xD;
      Methods: This study is a randomized clinical trial with a two-factor (2x7) research design.&#xD;
      The TCS patients will be randomly assigned in one of the two treatment groups: capsule&#xD;
      surgery and conservative treatment. Seven outcome measures will be collected pre-operative&#xD;
      for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits,&#xD;
      including: (1) International Consultation on Incontinence Modular Questionnaire Short Version&#xD;
      (ICI-Q-SF) to assess the urinary functions, (2) Rintala Score for bowel function, (3) a new&#xD;
      developed Chinese version of questionnaire to assess the quality of life in patients and&#xD;
      parents due to bladder dysfunction. (4) Oswestry disability index (ODI) to assess the&#xD;
      function of back and lower limbs, (5)SF-12 for whole quality of life, (6) Pirani score to&#xD;
      assess clubfoot deformity, and (7) foot function index to assess the impacts on quality of&#xD;
      life due to clubfoot. Urodynamics, bladder ultrasonography, muscle strength and sensation of&#xD;
      lower limbs will be obtained before and post treatment, to determine the patient's function&#xD;
      of lower limbs. The investigator performing the outcome measures will be blinded to group&#xD;
      assignment, and therefore will not participate in treatment. After randomization, the&#xD;
      conservative group will be followed up in the outpatient clinic. The capsule surgery group&#xD;
      will receive the nerve root axial decompression surgery.&#xD;
&#xD;
      Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences&#xD;
      in the four measures between groups and at the five different time frames with the α level&#xD;
      set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the&#xD;
      differences in the urodynamics and muscle strength data over time and between groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 16, 2017</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2019</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>Single (Outcomes Assessor)</masking>
    <masking_description>The statistical analysist do not know the group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of patient-reported scores assessing bladder function</measure>
    <time_frame>At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.</time_frame>
    <description>International Consultation on Incontinence Modular Questionnaire Short Version (ICI-Q-SF) is used to assess urinary function and the impacts on patient's quality of life due to urinary problems.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of patient-reported scores assessing bowel function</measure>
    <time_frame>At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.</time_frame>
    <description>Rintala Score is applied to assess bowel function and its effects on patients' quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of patient-reported quality of life due to bladder dysfuction</measure>
    <time_frame>At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.</time_frame>
    <description>A new developed Chinese version of questionnaire is used to assess the quality of life in patients and parents due to bladder dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bladder function</measure>
    <time_frame>At 1 week pre- and 1, 12, 48, and 96 weeks post-operative follow-up visits.</time_frame>
    <description>Urodynamic testing is performed to determine the bladder function, including bladder pressure, bladder capacity, residual volume, and compliance of bladder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle power</measure>
    <time_frame>At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.</time_frame>
    <description>Muscle power is tested by manual assessment, which is classified into 6 levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvment of clubfoot deformity</measure>
    <time_frame>At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.</time_frame>
    <description>Pirani questionnaire is applied to assess the severity of clubfoot deformity by the examiner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of patient-reported scores assessing foot deformity</measure>
    <time_frame>At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.</time_frame>
    <description>Foot function index is applied to assess the impacts on patients' quality of life due to foot deformity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of patient-reported scores assessing function of back and lower limbs</measure>
    <time_frame>At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.</time_frame>
    <description>Oswestry disability index (ODI) is applied to assess the function of back and lower limbs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of patient-reported quality of life</measure>
    <time_frame>At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.</time_frame>
    <description>SF-12 is applied to assess the impacts on quality of life due to tethered cord syndrome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Tethered Cord Syndrome</condition>
  <arm_group>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Conservative physiotherapy, intermittent catheterization, or drug treatment for bladder or bowel dysfunction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Capsule surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nerve root axial decompression surgery (Capsule surgery)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conservative treatment</intervention_name>
    <description>The conservative treatment group will be given diet and nursing guidance, then the drug treatment or physiotherapy will be given according to the conditions of patients. Patients with bladder dysfunction will be guided to perform routine intermittent catheterization with help of their parents.</description>
    <arm_group_label>Conservative treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Capsule surgery</intervention_name>
    <description>In the multiple segments of the spine, articular facet joint and intervertebral disc will be resected to achieve the effect of decompression.&#xD;
Specific surgical segments, osteotomy range, decompression degree of each patient needs to be designed individually.</description>
    <arm_group_label>Capsule surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients aged 14-20 years, without gender limitation, are willing to sign informed&#xD;
             consent;&#xD;
&#xD;
          2. patients diagnosed with tethered cord syndrome (TCS);&#xD;
&#xD;
          3. patients accepted untethering surgery or resection of intra-lipomas or&#xD;
             myelomeningocele after birth;&#xD;
&#xD;
          4. patients present with the recent occurrence of bladder or bowel dysfunction, with&#xD;
             progressive deterioration, may be accompanied by motor deficits of lower extremity;&#xD;
&#xD;
          5. urodynamic examination suggests neurogenic injury;&#xD;
&#xD;
          6. the current conventional treatment is difficult to achieve satisfactory clinical&#xD;
             outcomes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. bladder or ureter obstruction;&#xD;
&#xD;
          2. other types of neurogenic bladder dysfunction (spinal cord injury, cerebral palsy,&#xD;
             other brain injuries);&#xD;
&#xD;
          3. anorectal malformations;&#xD;
&#xD;
          4. poor health condition, unable to tolerate surgery;&#xD;
&#xD;
          5. patients (or their guardians) cannot give full informed consent for cognitive&#xD;
             dysfunction;&#xD;
&#xD;
          6. patients who have participated in other clinical trials in the past 1 month.&#xD;
&#xD;
          7. patients with active hepatitis B (including HBeAg) or serological markers (HBsAg or /&#xD;
             and HBeAg or / and HBcAb), hepatitis C, tuberculosis, cytomegalovirus infection,&#xD;
             severe fungal infection or HIV infection;&#xD;
&#xD;
          8. patients with active peptic ulcers within 3 months before randomization.&#xD;
&#xD;
          9. patients with malignant neoplasms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiangang Shi, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Changzheng Hospital, Second Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ximing Xu, MD</last_name>
    <phone>+8618801784094</phone>
    <email>xi_mingxu@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Changzheng Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ximing Xu, MD</last_name>
      <phone>18801784094</phone>
      <email>xi_mingxu@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Steinbok P, MacNeily AE, Hengel AR, Afshar K, Landgraf JM, Hader W, Pugh J. Filum Section for Urinary Incontinence in Children with Occult Tethered Cord Syndrome: A Randomized, Controlled Pilot Study. J Urol. 2016 Apr;195(4 Pt 2):1183-8. doi: 10.1016/j.juro.2015.09.082. Epub 2016 Feb 28.</citation>
    <PMID>26926544</PMID>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>September 26, 2018</last_update_submitted>
  <last_update_submitted_qc>September 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Changzheng Hospital</investigator_affiliation>
    <investigator_full_name>Jiangang Shi</investigator_full_name>
    <investigator_title>Chief of No.2 department of spinal surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neural Tube Defects</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03262844
org study id: CZ1702TCS
nct id: NCT03262844
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a
      series of neurological dysfunctions and deformities attributable to abnormally increased
      tension on the spinal cord, which is lacking effective treatment to relieve the symptoms and
      prevent progression. Dr. Shi recently proposed a new technique as nerve root axial
      decompression surgery, which is also called capsule surgery, to treat patients with TCS. Yet,
      the effectiveness and safety should be further studied.

      Purpose: The aim of this study is to compare the effectiveness and safety of clinical
      outcomes between capsule surgery and conservative treatment in patients with TCS. A study
      hypothesis is that outcomes will be improved after capsule surgery.

      Methods: This study is a randomized clinical trial with a two-factor (2x7) research design.
      The TCS patients will be randomly assigned in one of the two treatment groups: capsule
      surgery and conservative treatment. Seven outcome measures will be collected pre-operative
      for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits,
      including: International Consultation on Incontinence Modular Questionnaire Short Version
      (ICI-Q-SF), Rintala Score, a new developed Chinese version of questionnaire, Oswestry
      disability index (ODI), SF-12, foot function index (FFI) and Pirani score. Urodynamic
      testing, bladder ultrasonography, electromyogram, muscle strength and sensation of lower
      limbs will be obtained before and post treatment, to determine the patient's function of
      lower limbs. The investigator performing the outcome measures will be blinded to group
      assignment, and therefore will not participate in treatment. After randomization, the
      conservative group will be followed up in the outpatient clinic. The capsule surgery group
      will receive the nerve root axial decompression surgery (capsule surgery).

      Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences
      in the seven measures between groups and at the five different time frames with the α level
      set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the
      differences in the urodynamics and muscle strength data over time and between groups.
Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a
      series of neurological dysfunctions and deformities attributable to abnormally increased
      tension on the spinal cord. The standard surgical treatment is untethering the spinal cord
      and correction of the related deformity. Although reported results are encouraging, it
      continues to pose challenges on management of TCS patients. Symptomatic re-tethering seems to
      be an inevitable result, which occurs in 20%-50% patients after untethering. Recently, filum
      dissection was found no good to improve urinary symptoms compared to conservative treatment
      in teenagers as reported in an RCT study. Also, it remained controversy when to perform the
      surgery and how to evaluate the benefits of surgery or conservative treatment. Dr. Shi
      recently proposed a new technique as nerve root axial decompression surgery, which is also
      called capsule surgery, to treat patients with TCS. Yet, the effectiveness and safety should
      be further studied.

      Purpose: The aim of this study is to compare the effectiveness and safety of clinical
      outcomes between capsule surgery and conservative treatment in patients with TCS. A study
      hypothesis is that outcomes will be improved after capsule surgery.

      Methods: This study is a randomized clinical trial with a two-factor (2x7) research design.
      The TCS patients will be randomly assigned in one of the two treatment groups: capsule
      surgery and conservative treatment. Seven outcome measures will be collected pre-operative
      for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits,
      including: (1) International Consultation on Incontinence Modular Questionnaire Short Version
      (ICI-Q-SF) to assess the urinary functions, (2) Rintala Score for bowel function, (3) a new
      developed Chinese version of questionnaire to assess the quality of life in patients and
      parents due to bladder dysfunction. (4) Oswestry disability index (ODI) to assess the
      function of back and lower limbs, (5)SF-12 for whole quality of life, (6) Pirani score to
      assess clubfoot deformity, and (7) foot function index to assess the impacts on quality of
      life due to clubfoot. Urodynamics, bladder ultrasonography, muscle strength and sensation of
      lower limbs will be obtained before and post treatment, to determine the patient's function
      of lower limbs. The investigator performing the outcome measures will be blinded to group
      assignment, and therefore will not participate in treatment. After randomization, the
      conservative group will be followed up in the outpatient clinic. The capsule surgery group
      will receive the nerve root axial decompression surgery.

      Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences
      in the four measures between groups and at the five different time frames with the α level
      set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the
      differences in the urodynamics and muscle strength data over time and between groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The statistical analysist do not know the group assignment.
measure: Changes of patient-reported scores assessing bladder function
time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
description: International Consultation on Incontinence Modular Questionnaire Short Version (ICI-Q-SF) is used to assess urinary function and the impacts on patient's quality of life due to urinary problems.
measure: Changes of patient-reported scores assessing bowel function
time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
description: Rintala Score is applied to assess bowel function and its effects on patients' quality of life.
measure: Changes of patient-reported quality of life due to bladder dysfuction
time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
description: A new developed Chinese version of questionnaire is used to assess the quality of life in patients and parents due to bladder dysfunction.
measure: Bladder function
time frame: At 1 week pre- and 1, 12, 48, and 96 weeks post-operative follow-up visits.
description: Urodynamic testing is performed to determine the bladder function, including bladder pressure, bladder capacity, residual volume, and compliance of bladder.
measure: Muscle power
time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
description: Muscle power is tested by manual assessment, which is classified into 6 levels.
measure: Improvment of clubfoot deformity
time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
description: Pirani questionnaire is applied to assess the severity of clubfoot deformity by the examiner.
measure: Changes of patient-reported scores assessing foot deformity
time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
description: Foot function index is applied to assess the impacts on patients' quality of life due to foot deformity
measure: Changes of patient-reported scores assessing function of back and lower limbs
time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
description: Oswestry disability index (ODI) is applied to assess the function of back and lower limbs.
measure: Changes of patient-reported quality of life
time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
description: SF-12 is applied to assess the impacts on quality of life due to tethered cord syndrome.
arm group label: Conservative treatment
arm group type: Placebo Comparator
description: Conservative physiotherapy, intermittent catheterization, or drug treatment for bladder or bowel dysfunction
arm group label: Capsule surgery
arm group type: Experimental
description: Nerve root axial decompression surgery (Capsule surgery)
intervention type: Behavioral
intervention name: Conservative treatment
description: The conservative treatment group will be given diet and nursing guidance, then the drug treatment or physiotherapy will be given according to the conditions of patients. Patients with bladder dysfunction will be guided to perform routine intermittent catheterization with help of their parents.
arm group label: Conservative treatment
intervention type: Procedure
intervention name: Capsule surgery
description: In the multiple segments of the spine, articular facet joint and intervertebral disc will be resected to achieve the effect of decompression.
Specific surgical segments, osteotomy range, decompression degree of each patient needs to be designed individually.
arm group label: Capsule surgery
criteria: 
gender: All
minimum age: 14 Years
maximum age: 20 Years
healthy volunteers: No
last name: Jiangang Shi, MD
role: Study Chair
affiliation: Shanghai Changzheng Hospital, Second Military Medical University
last name: Ximing Xu, MD
phone: +8618801784094
email: xi_mingxu@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
citation: Steinbok P, MacNeily AE, Hengel AR, Afshar K, Landgraf JM, Hader W, Pugh J. Filum Section for Urinary Incontinence in Children with Occult Tethered Cord Syndrome: A Randomized, Controlled Pilot Study. J Urol. 2016 Apr;195(4 Pt 2):1183-8. doi: 10.1016/j.juro.2015.09.082. Epub 2016 Feb 28.
PMID: 26926544
responsible party type: Principal Investigator
investigator affiliation: Shanghai Changzheng Hospital
investigator full name: Jiangang Shi
investigator title: Chief of No.2 department of spinal surgery
mesh term: Neural Tube Defects
mesh term: Syndrome
sharing ipd: Undecided