<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/NCT04469387</url>
  </required_header>
  <id_info>
    <org_study_id>M2020285</org_study_id>
    <nct_id>NCT04469387</nct_id>
  </id_info>
  <brief_title>Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion</brief_title>
  <official_title>Preventive Effect of Limited Decompression on Adjacent Segment With Pre-existing Spinal Canal Stenosis Following Posterior Lumbar Interbody Fusion: a Prospective Interventional 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 degenerative disease are prospectively enrolled and followed. Patients&#xD;
      enrolled in this study have asymptomatic pre-existing spinal canal stenosis at adjacent&#xD;
      segment. This study will focus on the effects of preventative limited decompression at&#xD;
      adjacent segment.&#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. Previous&#xD;
      studies have reported asymptomatic pre-existing spinal canal stenosis (SCS) as a risk factor&#xD;
      for ASDis that requires additional surgery. Appropriate strategy needs to be explored for the&#xD;
      treatment of asymptomatic pre-existing spinal canal stenosis.&#xD;
&#xD;
      Limited decompressions, including partial laminotomy and flavectomy, have been proved to have&#xD;
      the role of enlargement in spinal canal. Therefore, we hypothesize that limited&#xD;
      decompressions at adjacent segment with asymptomatic pre-existing SCS will have the&#xD;
      preventive effect on ASP.&#xD;
&#xD;
      This prospective study will be limited to patients with the same preoperative pathology, the&#xD;
      same fusion segments (L4-5 and L5-S1), the same fusion technique (PLIF). Dynamic X-ray and&#xD;
      MRI examinations of lumbar will be completed to evaluate the imaging manifestations of the&#xD;
      responsible and adjacent segments before surgery. Patients with asymptomatic pre-existing&#xD;
      canal stenosis factors (cerebrospinal fluid occlusion grade 1) at L3/4 segment will be&#xD;
      enrolled. Patients will be randomly divided into two groups according to different&#xD;
      strategies. NS Group includes patients who simply receive responsible segments fused (L4-S1).&#xD;
      LD Group includes patients who receive responsible segments fused (L4-S1) plus limited&#xD;
      decompression at adjacent segment (L3/4). In terms of limited decompression at the adjacent&#xD;
      segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle&#xD;
      will be performed. Complete laminectomy and destroy of posterior ligament complex will be&#xD;
      avoided.&#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, 5 and 10 years. The clinical outcomes and ASP will be&#xD;
      recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2032</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adjacent segment degeneration</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</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</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</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</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_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</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>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NS Group includes patients who simply receive responsible segments fused (L4-S1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LD Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LD Group includes patients who receive responsible segments fused (L4-S1) plus limited decompression at adjacent segment (L3/4).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosis</intervention_name>
    <description>In terms of limited decompression at the adjacent segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle will be performed. Complete laminectomy and destroy of posterior ligament complex will be avoided.</description>
    <arm_group_label>LD Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Responsible segments fused</intervention_name>
    <description>In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).</description>
    <arm_group_label>LD Group</arm_group_label>
    <arm_group_label>NS Group</arm_group_label>
  </intervention>
  <eligibility>
    <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;
          -  Patients have asymptomatic pre-existing spinal canal stenosis (cerebrospinal fluid&#xD;
             occlusion grade=1) at adjacent segment.&#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>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>Zhong ZM, Deviren V, Tay B, Burch S, Berven SH. Adjacent segment disease after instrumented fusion for adult lumbar spondylolisthesis: Incidence and risk factors. Clin Neurol Neurosurg. 2017 May;156:29-34. doi: 10.1016/j.clineuro.2017.02.020. Epub 2017 Feb 27.</citation>
    <PMID>28288396</PMID>
  </results_reference>
  <results_reference>
    <citation>Alentado VJ, Lubelski D, Healy AT, Orr RD, Steinmetz MP, Benzel EC, Mroz TE. Predisposing Characteristics of Adjacent Segment Disease After Lumbar Fusion. Spine (Phila Pa 1976). 2016 Jul 15;41(14):1167-1172. doi: 10.1097/BRS.0000000000001493.</citation>
    <PMID>26863261</PMID>
  </results_reference>
  <results_reference>
    <citation>Hikata T, Kamata M, Furukawa M. Risk factors for adjacent segment disease after posterior lumbar interbody fusion and efficacy of simultaneous decompression surgery for symptomatic adjacent segment disease. J Spinal Disord Tech. 2014 Apr;27(2):70-5. doi: 10.1097/BSD.0b013e31824e5292.</citation>
    <PMID>22460400</PMID>
  </results_reference>
  <results_reference>
    <citation>Matsumoto T, Okuda S, Nagamoto Y, Sugiura T, Takahashi Y, Iwasaki M. Effects of Concomitant Decompression Adjacent to a Posterior Lumbar Interbody Fusion Segment on Clinical and Radiologic Outcomes: Comparative Analysis 5 Years After Surgery. Global Spine J. 2019 Aug;9(5):505-511. doi: 10.1177/2192568218803324. Epub 2018 Oct 8.</citation>
    <PMID>31431873</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>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>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adjacent segment degeneration</keyword>
  <keyword>Adjacent segment disease</keyword>
  <keyword>Pre-existing degeneration</keyword>
  <keyword>Limited decompression</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>
    <mesh_term>Constriction, Pathologic</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/NCT04469387
org study id: M2020285
nct id: NCT04469387
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 degenerative disease are prospectively enrolled and followed. Patients
      enrolled in this study have asymptomatic pre-existing spinal canal stenosis at adjacent
      segment. This study will focus on the effects of preventative limited decompression at
      adjacent segment.
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. Previous
      studies have reported asymptomatic pre-existing spinal canal stenosis (SCS) as a risk factor
      for ASDis that requires additional surgery. Appropriate strategy needs to be explored for the
      treatment of asymptomatic pre-existing spinal canal stenosis.

      Limited decompressions, including partial laminotomy and flavectomy, have been proved to have
      the role of enlargement in spinal canal. Therefore, we hypothesize that limited
      decompressions at adjacent segment with asymptomatic pre-existing SCS will have the
      preventive effect on ASP.

      This prospective study will be 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. Patients with asymptomatic pre-existing
      canal stenosis factors (cerebrospinal fluid occlusion grade 1) at L3/4 segment will be
      enrolled. Patients will be randomly divided into two groups according to different
      strategies. NS Group includes patients who simply receive responsible segments fused (L4-S1).
      LD Group includes patients who receive responsible segments fused (L4-S1) plus limited
      decompression at adjacent segment (L3/4). In terms of limited decompression at the adjacent
      segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle
      will be performed. Complete laminectomy and destroy of posterior ligament complex will be
      avoided.

      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, 5 and 10 years. The clinical outcomes and ASP will be
      recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Adjacent segment degeneration
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
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
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
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
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
arm group type: Active Comparator
description: NS Group includes patients who simply receive responsible segments fused (L4-S1).
arm group label: LD Group
arm group type: Experimental
description: LD Group includes patients who receive responsible segments fused (L4-S1) plus limited decompression at adjacent segment (L3/4).
intervention type: Procedure
intervention name: Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosis
description: In terms of limited decompression at the adjacent segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle will be performed. Complete laminectomy and destroy of posterior ligament complex will be avoided.
arm group label: LD Group
intervention type: Procedure
intervention name: Responsible segments fused
description: In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).
arm group label: LD Group
arm group label: NS Group
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: 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: Zhong ZM, Deviren V, Tay B, Burch S, Berven SH. Adjacent segment disease after instrumented fusion for adult lumbar spondylolisthesis: Incidence and risk factors. Clin Neurol Neurosurg. 2017 May;156:29-34. doi: 10.1016/j.clineuro.2017.02.020. Epub 2017 Feb 27.
PMID: 28288396
citation: Alentado VJ, Lubelski D, Healy AT, Orr RD, Steinmetz MP, Benzel EC, Mroz TE. Predisposing Characteristics of Adjacent Segment Disease After Lumbar Fusion. Spine (Phila Pa 1976). 2016 Jul 15;41(14):1167-1172. doi: 10.1097/BRS.0000000000001493.
PMID: 26863261
citation: Hikata T, Kamata M, Furukawa M. Risk factors for adjacent segment disease after posterior lumbar interbody fusion and efficacy of simultaneous decompression surgery for symptomatic adjacent segment disease. J Spinal Disord Tech. 2014 Apr;27(2):70-5. doi: 10.1097/BSD.0b013e31824e5292.
PMID: 22460400
citation: Matsumoto T, Okuda S, Nagamoto Y, Sugiura T, Takahashi Y, Iwasaki M. Effects of Concomitant Decompression Adjacent to a Posterior Lumbar Interbody Fusion Segment on Clinical and Radiologic Outcomes: Comparative Analysis 5 Years After Surgery. Global Spine J. 2019 Aug;9(5):505-511. doi: 10.1177/2192568218803324. Epub 2018 Oct 8.
PMID: 31431873
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: 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
mesh term: Constriction, Pathologic
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.