<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/NCT04467944</url>
  </required_header>
  <id_info>
    <org_study_id>M2017399</org_study_id>
    <nct_id>NCT04467944</nct_id>
  </id_info>
  <brief_title>Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery</brief_title>
  <official_title>Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      This is a prospective single-center study. Patients requiring posterior lumbar interbody&#xD;
      fusion (PLIF) for lumbar degenerative disease are prospectively enrolled and followed.&#xD;
      Important adjacent pre-existing degeneration factors include discs degenerated, facets and&#xD;
      ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). This study will&#xD;
      focus on the effects of pre- existing adjacent degeneration (disc factors and spinal canal&#xD;
      stenosis factors) on long-term postoperative outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adjacent segment pathologies (ASP), including radiological adjacent segment degeneration&#xD;
      (ASDeg) and adjacent segment disease (ASDis) after lumbar fusion surgeries have been&#xD;
      troubling complications. The development of ASDis greatly reduces postoperative quality of&#xD;
      life, and revision surgery may be required in severe cases. Several risk factors for ASP have&#xD;
      been reported, such as age, sex, pre-existing adjacent degeneration, multilevel fusions,&#xD;
      sagittal imbalance, the type of fusion, facet tropism and laminar inclination. Because&#xD;
      multi-level degenerative imaging is common in lumbar degenerative disease, pre-existing&#xD;
      adjacent degeneration makes challenge for the surgery strategy, sometimes it is difficult to&#xD;
      determine the level at which fusion ends. Important pre-existing adjacent degeneration&#xD;
      factors included discs degenerated, facets and ligamentum flavum tropism which could lead to&#xD;
      spinal canal stenosis (SCS). Few studies have focused on asymptomatic pre-existing SCS as a&#xD;
      risk factor for ASDis that requires additional surgery at an adjacent segment. But these&#xD;
      studies only used the sagittal diameter or ratio to evaluate the degree of adjacent SCS. The&#xD;
      status of neural tissues in the canal was neglected. Few studies also have focused on&#xD;
      asymptomatic pre-existing degenerated disc as a risk factor for ASDeg. But these studies only&#xD;
      used Pfirrmann grade to evaluate the degenerated disc. High-intensity zone (Hiz), vacuum sign&#xD;
      were neglected.&#xD;
&#xD;
      This prospective study was limited to patients with the same preoperative pathology, the same&#xD;
      fusion segments (L4-5 and L5-S1), the same fusion technique (PLIF). Dynamic X-ray and MRI&#xD;
      examinations of lumbar will be completed to evaluate the imaging manifestations of the&#xD;
      responsible and adjacent segments before surgery. The T2-weighted sagittal and axial MRI&#xD;
      images are studied and the following parameters are recorded: grade of cerebrospinal fluid&#xD;
      occlusion in L3/4 spinal canal at disc level, and the narrowest axial plane was used for&#xD;
      grading; L3/4 disc degeneration by Pfirrmann grade; high-intensity zone (Hiz) and vacuum sign&#xD;
      of L3/4 disc; L3/4 disc herniation quantificationally measured by MSU Classification;&#xD;
      Patients will be divided into three groups according to the pre-existing status of L3/4&#xD;
      segment. Patients without pre-existing degeneration at L3/4 segment will be classified into&#xD;
      control group (NS group). Patients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or&#xD;
      vacuum sign) at L3/4 segment will be classified into group D. Patients with pre-existing&#xD;
      canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified&#xD;
      into group C.&#xD;
&#xD;
      The patient's age, gender, preoperative body mass index (BMI), American Society of&#xD;
      Anesthesiologists classification of anesthesia (ASA grade) will be recorded during the&#xD;
      hospital stay. Surgical data including operation time, blood loss, perioperative&#xD;
      complications (including cerebrospinal fluid leakage, wound infection, postoperative&#xD;
      neurological dysfunction, and perioperative secondary surgery, cardiopulmonary complication,&#xD;
      cerebral infarction/hemorrhage, etc.), and length of hospital stay are also recorded.&#xD;
      Preoperative clinical function questionnaires, including visual analog scale (VAS) of low&#xD;
      back, VAS of the legs, and Oswestry Disability Index (ODI) scores for patients were completed&#xD;
      on admission for surgery without any assistance. All the patients enrolled will finished the&#xD;
      follow-up from date of surgery at 1,2 and 5 years. The clinical outcomes and ASP will be&#xD;
      recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2032</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adjacent segment degeneration (ASDeg)</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adjacent segment degeneration (ASDeg)</measure>
    <time_frame>24 months after surgery</time_frame>
    <description>ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adjacent segment degeneration (ASDeg)</measure>
    <time_frame>60 months after surgery</time_frame>
    <description>ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adjacent segment degeneration (ASDeg)</measure>
    <time_frame>120 months after surgery</time_frame>
    <description>ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adjacent segment disease (ASDis)</measure>
    <time_frame>The entire study process, up to 120 months after surgery.</time_frame>
    <description>ASDis is defined as clinical and radiographic evidence of degenerative spinal disease (disc degeneration, stenosis, or spondylolisthesis) on the level adjacent to the index fusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.</time_frame>
    <description>The Oswestry Disability Index (ODI) (0-100) is used to assess disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Back pain</measure>
    <time_frame>12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.</time_frame>
    <description>The Visual Analog Scale (0-10) is used to evaluate back pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leg pain</measure>
    <time_frame>12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.</time_frame>
    <description>The Visual Analog Scale (0-10) is used to evaluate leg pain.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Degenerative Lumbar Spinal Stenosis</condition>
  <condition>Degenerative Disc Disease</condition>
  <condition>Degeneration Spine</condition>
  <arm_group>
    <arm_group_label>NS Group</arm_group_label>
    <description>Patients without pre-existing degeneration at L3/4 segment will be classified into control group (NS group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D Group</arm_group_label>
    <description>Patients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or vacuum sign) at L3/4 segment will be classified into group D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C Group</arm_group_label>
    <description>Patients with pre-existing canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified into group C.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-existing degenerative factors at adjacent segment</intervention_name>
    <description>Pre-existing degenerative factors at adjacent segment, including disc factors and canal stenosis factors</description>
    <arm_group_label>C Group</arm_group_label>
    <arm_group_label>D Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In the orthopaedic department of Peking University Third Hospital, patients with a clear&#xD;
        diagnosis of lumbar degenerative disease, and surgical level of L4-S1 will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A clear diagnosis of lumbar spinal stenosis, and surgical level of L4- S1 (The levels&#xD;
             to be operated on were decided by matching the clinical symptomatology with the&#xD;
             radiological findings of the spinal levels that needed decompression);&#xD;
&#xD;
          -  Failed at least eight weeks conservative treatment;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable factors (slip, rotation, lateral bending, etc.) in adjacent segment L3/4;&#xD;
&#xD;
          -  Preoperative sagittal and coronal imbalance of the spine;&#xD;
&#xD;
          -  Lumbar infection and/or tumor diseases;&#xD;
&#xD;
          -  A previous history of lumbar fusion surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Shi Li, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhuo Ran Sun, Dr.</last_name>
    <phone>+8618610292513</phone>
    <email>puh3_szr@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Da Zou, M.D.</last_name>
      <email>zd_puth@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Lee JC, Kim Y, Soh JW, Shin BJ. Risk factors of adjacent segment disease requiring surgery after lumbar spinal fusion: comparison of posterior lumbar interbody fusion and posterolateral fusion. Spine (Phila Pa 1976). 2014 Mar 1;39(5):E339-45. doi: 10.1097/BRS.0000000000000164.</citation>
    <PMID>24365899</PMID>
  </results_reference>
  <results_reference>
    <citation>Lawrence BD, Wang J, Arnold PM, Hermsmeyer J, Norvell DC, Brodke DS. Predicting the risk of adjacent segment pathology after lumbar fusion: a systematic review. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S123-32. doi: 10.1097/BRS.0b013e31826d60d8.</citation>
    <PMID>22885827</PMID>
  </results_reference>
  <results_reference>
    <citation>Yugue I, Okada S, Masuda M, Ueta T, Maeda T, Shiba K. Risk factors for adjacent segment pathology requiring additional surgery after single-level spinal fusion: impact of pre-existing spinal stenosis demonstrated by preoperative myelography. Eur Spine J. 2016 May;25(5):1542-1549. doi: 10.1007/s00586-015-4185-6. Epub 2015 Aug 14.</citation>
    <PMID>26272373</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee GY, Lee JW, Choi HS, Oh KJ, Kang HS. A new grading system of lumbar central canal stenosis on MRI: an easy and reliable method. Skeletal Radiol. 2011 Aug;40(8):1033-9. doi: 10.1007/s00256-011-1102-x. Epub 2011 Feb 1. Erratum In: Skeletal Radiol. 2011 Aug;40(8):1127. Guen, Young Lee [corrected to Lee, Guen Young]; Joon, Woo Lee [corrected to Lee, Joon Woo]; Hee, Seok Choi [corrected to Choi, Hee Seok]; Kyoung-Jin, Oh [corrected to Oh, Kyoung-Jin]; Heung, Sik Kang [corrected to Kang, Heung Sik].</citation>
    <PMID>21286714</PMID>
  </results_reference>
  <results_reference>
    <citation>Mysliwiec LW, Cholewicki J, Winkelpleck MD, Eis GP. MSU classification for herniated lumbar discs on MRI: toward developing objective criteria for surgical selection. Eur Spine J. 2010 Jul;19(7):1087-93. doi: 10.1007/s00586-009-1274-4. Epub 2010 Jan 19.</citation>
    <PMID>20084410</PMID>
  </results_reference>
  <results_reference>
    <citation>Nakashima H, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A, Tauchi R, Ohta K, Hamajima N, Imagama S. Adjacent Segment Disease After Posterior Lumbar Interbody Fusion: Based on Cases With a Minimum of 10 Years of Follow-up. Spine (Phila Pa 1976). 2015 Jul 15;40(14):E831-41. doi: 10.1097/BRS.0000000000000917.</citation>
    <PMID>25839385</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cerebrospinal fluid occlusion</keyword>
  <keyword>Pre-existing degeneration</keyword>
  <keyword>Spinal canal stenosis</keyword>
  <keyword>Adjacent segment degeneration</keyword>
  <keyword>Adjacent segment disease</keyword>
  <keyword>High-intensity zone</keyword>
  <keyword>Vacuum sign</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will make the clinical study report available for half a year after the publication of the results of the study.</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The IPD will become available for half a year after the publication of the results of the study.</ipd_time_frame>
    <ipd_access_criteria>The IPD is available to the readers of the journal in which our research is published. The corresponding author of the published papers will review the requests.</ipd_access_criteria>
  </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/NCT04467944
org study id: M2017399
nct id: NCT04467944
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective single-center study. Patients requiring posterior lumbar interbody
      fusion (PLIF) for lumbar degenerative disease are prospectively enrolled and followed.
      Important adjacent pre-existing degeneration factors include discs degenerated, facets and
      ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). This study will
      focus on the effects of pre- existing adjacent degeneration (disc factors and spinal canal
      stenosis factors) on long-term postoperative outcomes.
Adjacent segment pathologies (ASP), including radiological adjacent segment degeneration
      (ASDeg) and adjacent segment disease (ASDis) after lumbar fusion surgeries have been
      troubling complications. The development of ASDis greatly reduces postoperative quality of
      life, and revision surgery may be required in severe cases. Several risk factors for ASP have
      been reported, such as age, sex, pre-existing adjacent degeneration, multilevel fusions,
      sagittal imbalance, the type of fusion, facet tropism and laminar inclination. Because
      multi-level degenerative imaging is common in lumbar degenerative disease, pre-existing
      adjacent degeneration makes challenge for the surgery strategy, sometimes it is difficult to
      determine the level at which fusion ends. Important pre-existing adjacent degeneration
      factors included discs degenerated, facets and ligamentum flavum tropism which could lead to
      spinal canal stenosis (SCS). Few studies have focused on asymptomatic pre-existing SCS as a
      risk factor for ASDis that requires additional surgery at an adjacent segment. But these
      studies only used the sagittal diameter or ratio to evaluate the degree of adjacent SCS. The
      status of neural tissues in the canal was neglected. Few studies also have focused on
      asymptomatic pre-existing degenerated disc as a risk factor for ASDeg. But these studies only
      used Pfirrmann grade to evaluate the degenerated disc. High-intensity zone (Hiz), vacuum sign
      were neglected.

      This prospective study was limited to patients with the same preoperative pathology, the same
      fusion segments (L4-5 and L5-S1), the same fusion technique (PLIF). Dynamic X-ray and MRI
      examinations of lumbar will be completed to evaluate the imaging manifestations of the
      responsible and adjacent segments before surgery. The T2-weighted sagittal and axial MRI
      images are studied and the following parameters are recorded: grade of cerebrospinal fluid
      occlusion in L3/4 spinal canal at disc level, and the narrowest axial plane was used for
      grading; L3/4 disc degeneration by Pfirrmann grade; high-intensity zone (Hiz) and vacuum sign
      of L3/4 disc; L3/4 disc herniation quantificationally measured by MSU Classification;
      Patients will be divided into three groups according to the pre-existing status of L3/4
      segment. Patients without pre-existing degeneration at L3/4 segment will be classified into
      control group (NS group). Patients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or
      vacuum sign) at L3/4 segment will be classified into group D. Patients with pre-existing
      canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified
      into group C.

      The patient's age, gender, preoperative body mass index (BMI), American Society of
      Anesthesiologists classification of anesthesia (ASA grade) will be recorded during the
      hospital stay. Surgical data including operation time, blood loss, perioperative
      complications (including cerebrospinal fluid leakage, wound infection, postoperative
      neurological dysfunction, and perioperative secondary surgery, cardiopulmonary complication,
      cerebral infarction/hemorrhage, etc.), and length of hospital stay are also recorded.
      Preoperative clinical function questionnaires, including visual analog scale (VAS) of low
      back, VAS of the legs, and Oswestry Disability Index (ODI) scores for patients were completed
      on admission for surgery without any assistance. All the patients enrolled will finished the
      follow-up from date of surgery at 1,2 and 5 years. The clinical outcomes and ASP will be
      recorded.
observational model: Cohort
time perspective: Prospective
measure: Adjacent segment degeneration (ASDeg)
time frame: 12 months after surgery
description: ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
measure: Adjacent segment degeneration (ASDeg)
time frame: 24 months after surgery
description: ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
measure: Adjacent segment degeneration (ASDeg)
time frame: 60 months after surgery
description: ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
measure: Adjacent segment degeneration (ASDeg)
time frame: 120 months after surgery
description: ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression ≥1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of ≥ 3 mm in vertebral slippage, a change of ≥ 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.
measure: Adjacent segment disease (ASDis)
time frame: The entire study process, up to 120 months after surgery.
description: ASDis is defined as clinical and radiographic evidence of degenerative spinal disease (disc degeneration, stenosis, or spondylolisthesis) on the level adjacent to the index fusion.
measure: Disability
time frame: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
description: The Oswestry Disability Index (ODI) (0-100) is used to assess disability.
measure: Back pain
time frame: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
description: The Visual Analog Scale (0-10) is used to evaluate back pain.
measure: Leg pain
time frame: 12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
description: The Visual Analog Scale (0-10) is used to evaluate leg pain.
arm group label: NS Group
description: Patients without pre-existing degeneration at L3/4 segment will be classified into control group (NS group).
arm group label: D Group
description: Patients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or vacuum sign) at L3/4 segment will be classified into group D.
arm group label: C Group
description: Patients with pre-existing canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified into group C.
intervention type: Other
intervention name: Pre-existing degenerative factors at adjacent segment
description: Pre-existing degenerative factors at adjacent segment, including disc factors and canal stenosis factors
arm group label: C Group
arm group label: D Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wei Shi Li, Dr.
role: Principal Investigator
affiliation: Peking University Third Hospital
last name: Zhuo Ran Sun, Dr.
phone: +8618610292513
email: puh3_szr@outlook.com
facility: 
status: Recruiting
contact: 
country: China
citation: Lee JC, Kim Y, Soh JW, Shin BJ. Risk factors of adjacent segment disease requiring surgery after lumbar spinal fusion: comparison of posterior lumbar interbody fusion and posterolateral fusion. Spine (Phila Pa 1976). 2014 Mar 1;39(5):E339-45. doi: 10.1097/BRS.0000000000000164.
PMID: 24365899
citation: Lawrence BD, Wang J, Arnold PM, Hermsmeyer J, Norvell DC, Brodke DS. Predicting the risk of adjacent segment pathology after lumbar fusion: a systematic review. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S123-32. doi: 10.1097/BRS.0b013e31826d60d8.
PMID: 22885827
citation: Yugue I, Okada S, Masuda M, Ueta T, Maeda T, Shiba K. Risk factors for adjacent segment pathology requiring additional surgery after single-level spinal fusion: impact of pre-existing spinal stenosis demonstrated by preoperative myelography. Eur Spine J. 2016 May;25(5):1542-1549. doi: 10.1007/s00586-015-4185-6. Epub 2015 Aug 14.
PMID: 26272373
citation: Lee GY, Lee JW, Choi HS, Oh KJ, Kang HS. A new grading system of lumbar central canal stenosis on MRI: an easy and reliable method. Skeletal Radiol. 2011 Aug;40(8):1033-9. doi: 10.1007/s00256-011-1102-x. Epub 2011 Feb 1. Erratum In: Skeletal Radiol. 2011 Aug;40(8):1127. Guen, Young Lee [corrected to Lee, Guen Young]; Joon, Woo Lee [corrected to Lee, Joon Woo]; Hee, Seok Choi [corrected to Choi, Hee Seok]; Kyoung-Jin, Oh [corrected to Oh, Kyoung-Jin]; Heung, Sik Kang [corrected to Kang, Heung Sik].
PMID: 21286714
citation: Mysliwiec LW, Cholewicki J, Winkelpleck MD, Eis GP. MSU classification for herniated lumbar discs on MRI: toward developing objective criteria for surgical selection. Eur Spine J. 2010 Jul;19(7):1087-93. doi: 10.1007/s00586-009-1274-4. Epub 2010 Jan 19.
PMID: 20084410
citation: Nakashima H, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A, Tauchi R, Ohta K, Hamajima N, Imagama S. Adjacent Segment Disease After Posterior Lumbar Interbody Fusion: Based on Cases With a Minimum of 10 Years of Follow-up. Spine (Phila Pa 1976). 2015 Jul 15;40(14):E831-41. doi: 10.1097/BRS.0000000000000917.
PMID: 25839385
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Intervertebral Disc Degeneration
sharing ipd: Yes
ipd description: We will make the clinical study report available for half a year after the publication of the results of the study.
ipd info type: Clinical Study Report (CSR)
ipd time frame: The IPD will become available for half a year after the publication of the results of the study.
ipd access criteria: The IPD is available to the readers of the journal in which our research is published. The corresponding author of the published papers will review the requests.