xml: <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/NCT06024785</url>
    </required_header>
    <id_info>
      <org_study_id>VPRCT</org_study_id>
      <nct_id>NCT06024785</nct_id>
    </id_info>
    <brief_title>Vertebropexy - Randomized-controlled Trial</brief_title>
    <acronym>VPRCT</acronym>
    <official_title>Comparison of a New Ligamentous Fixation Technique Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Balgrist University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Balgrist University Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To assess the need for additional fusion surgery versus the risk of a revision surgery in&#xD;
        patients with degenerative lumbar spinal disease and to assess efficacy and risk of a new&#xD;
        ligamentous fixation technique (vertebropexy)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The global share of people over the age of 65 years has been consistently on the rise over&#xD;
        the past few decades, and is still projected to increase. The increasing life expectancy,&#xD;
        overall advances in medical care and therefore, the higher average age of people seeking&#xD;
        surgical treatment lead to increasing numbers of spine surgeries: Spinal fusion is one of the&#xD;
        most frequently used surgical treatment modalities for spinal disorders with 7.6 million per&#xD;
        year worldwide (EU: 700,000, USA: 450,000, CH: 9000) and provides stability by internal rigid&#xD;
        fixation of the spine with screws, rods and bony fusion. Although producing reliable&#xD;
        short-term results with rapid pain relief and positive effects on patient outcome,&#xD;
        implant-related complications, painful pseudarthrosis (non-union of bone), screw loosening,&#xD;
        and adjacent segment disease lead to one-third of patients requiring reoperation within 15&#xD;
        years. These complications might be evoked by altered biomechanics with redistribution of&#xD;
        loads and subsequently increased stress at the bone-implant interface as well as long fusions&#xD;
        leading to relevant, irreversible loss of motion. Therefore, a new treatment modality which&#xD;
        reinforces bony spinal segments with ligaments, the so called &quot;vertebropexy&quot;, was recently&#xD;
        developed by Farshad et al. The goal is to achieve targeted stabilization of the spine by&#xD;
        inserting ligamentous allografts to counteract instability, without immobilizing the segment.&#xD;
        Furthermore, it might provide additional stabilization after decompression surgery and&#xD;
        therefore reduce revision surgery rates due to instability in clinically relevant directions&#xD;
        as flexion-extension or anterior shear stress. However, to become a broadly accepted surgical&#xD;
        alternative to existing surgical techniques for degenerative lumbar spinal disease like&#xD;
        dorsal fusion and spinal decompression surgery, the new technique must provide convincing&#xD;
        long-term results superior to those of these established procedures which is the primary&#xD;
        objective of this randomized controlled trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">October 2027</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>
      <intervention_model_description>Stratification: Indication for decompression (study arm 1) or fusion (study arm 2)&#xD;
  Randomization within study arm 1 and study arm 2 between study intervention and control intervention</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>There is no blinding.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>ODI (Oswestry Disability Index)</measure>
      <time_frame>2 years postoperative</time_frame>
      <description>To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>VAS (Visual Analogue Scale)</measure>
      <time_frame>2 years postoperative</time_frame>
      <description>To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery. VAS scale 0-10, 10 meaning the highest pain score and 0 no pain at all.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SSM symptoms/function (Spinal Stenosis Measure)</measure>
      <time_frame>2 years postoperative</time_frame>
      <description>To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SSM satisfaction (Spinal Stenosis Measure)</measure>
      <time_frame>2 years postoperative</time_frame>
      <description>To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D (European Quality of Life Five Dimension)</measure>
      <time_frame>2 years postoperative</time_frame>
      <description>To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Revision surgery</measure>
      <time_frame>2 years postoperative</time_frame>
      <description>surgery on same and/or on adjacent levels</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>2 years postoperative</time_frame>
      <description>- intraoperative: lesion of nerve root, dural tear, lesion of vessels&#xD;
  - postoperative: surgical site infection, wound healing disorder, hematoma, paresis, material loosening (with fusion), material failure (with fusion), pseudarthrosis (with fusion), fracture, allograft tendon rupture (with vertebropexy)&#xD;
  - non-surgical: anesthesiological, cardiovascular, pulmonal, thromboembolic, death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of surgery</measure>
      <time_frame>Perioperative</time_frame>
      <description>Duration of intervention in minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>Perioperative</time_frame>
      <description>Duration of hospital stay in days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative blood loss</measure>
      <time_frame>Perioperative</time_frame>
      <description>Blood loss intraoperative in ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of analgesia</measure>
      <time_frame>2 years postoperative</time_frame>
      <description>Intake of analgetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of physical therapy</measure>
      <time_frame>2 years postoperative</time_frame>
      <description>Necessity to undergo further physical therapy (for instance due to remaining pain or function deficit)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">164</enrollment>
    <condition>Degeneration</condition>
    <condition>Spinal Stenosis</condition>
    <condition>Fusion of Spine</condition>
    <arm_group>
      <arm_group_label>Indication for decompression, randomization for decompression</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>microsurgical lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures; approach: bilateral or ipsilateral with cross-over to the contralateral side</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Indication for decompression, randomization for vertebropexy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side.&#xD;
  Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft), which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Indication for fusion, randomization for fusoin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>decompression and posterolateral instrumented fusion (arthrodesis) with implantation of pedicle screws, titanium alloy rods across the level of listhesis, an intervertebral fusion device and local autograft as well as DBX (demineralized bone matrix) to improve bony fusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Indication for fusion, randomization for vertebropexy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side.&#xD;
  Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft) which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Vertebropexy</intervention_name>
      <description>microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side.&#xD;
  Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft) which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.</description>
      <arm_group_label>Indication for decompression, randomization for decompression</arm_group_label>
      <arm_group_label>Indication for decompression, randomization for vertebropexy</arm_group_label>
      <arm_group_label>Indication for fusion, randomization for fusoin</arm_group_label>
      <arm_group_label>Indication for fusion, randomization for vertebropexy</arm_group_label>
      <other_name>ligamentous fixation of the spine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Single-level or two-level lumbar surgery&#xD;
  &#xD;
            -  Indication for decompression surgery in patients with spinal canal stenosis and&#xD;
               additional stable degenerative listhesis (without facet joint effusion ≥ 2mm)&#xD;
  &#xD;
            -  Indication for fusion surgery in patients with spinal canal stenosis and additional&#xD;
               unstable degenerative listhesis (facet joint effusion ≥ 2mm), in patients with&#xD;
               foraminal stenosis and additional degenerative listhesis, and in patients with segment&#xD;
               degeneration of the disc&#xD;
  &#xD;
            -  Understanding in German language&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Indication for decompression and/or fusion surgery in patients with solely disc&#xD;
               herniation, fractures, lytic listhesis, tumor&#xD;
  &#xD;
            -  Patients undergoing revision surgery for infection&#xD;
  &#xD;
            -  Patients undergoing revision surgery on the same level if bony structures have been&#xD;
               removed (e.g. prior laminectomy or midline decompression)&#xD;
  &#xD;
            -  Patients undergoing revision surgery in case of prior fusion surgery&#xD;
  &#xD;
            -  Surgery on level L5/S1&#xD;
  &#xD;
            -  Inability to understand the study for linguistic or cognitive reasons&#xD;
  &#xD;
            -  Anticipated clinical follow-up of less than 6 weeks after inclusion&#xD;
  &#xD;
            -  Participation in other clinical trials&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mazda Farshad, MD</last_name>
      <phone>+413861111</phone>
      <email>Mazda.Farshad@balgrist.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sabrina Catanzaro, RN</last_name>
      <phone>+413861111</phone>
      <email>Sabrina.Catanzaro@balgrist.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Balgrist University Hospital</name>
        <address>
          <city>Zurich</city>
          <zip>8008</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Mazda Farshad, MD</last_name>
        <phone>+413861111</phone>
        <email>Mazda.Farshad@balgrist.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <reference>
      <citation>Widmer J, Cornaz F, Scheibler G, Spirig JM, Snedeker JG, Farshad M. Biomechanical contribution of spinal structures to stability of the lumbar spine-novel biomechanical insights. Spine J. 2020 Oct;20(10):1705-1716. doi: 10.1016/j.spinee.2020.05.541. Epub 2020 May 28.</citation>
      <PMID>32474224</PMID>
    </reference>
    <reference>
      <citation>Farshad M, Tsagkaris C, Widmer J, Fasser MR, Cornaz F, Calek AK. Vertebropexy as a semi-rigid ligamentous alternative to lumbar spinal fusion. Eur Spine J. 2023 May;32(5):1695-1703. doi: 10.1007/s00586-023-07647-y. Epub 2023 Mar 17.</citation>
      <PMID>36930387</PMID>
    </reference>
    <reference>
      <citation>Calek AK, Widmer J, Fasser MR, Farshad M. Lumbar vertebropexy after unilateral total facetectomy. Spine J. 2023 Jul 13:S1529-9430(23)03259-X. doi: 10.1016/j.spinee.2023.07.005. Online ahead of print.</citation>
      <PMID>37451550</PMID>
    </reference>
    <reference>
      <citation>Calek AK, Altorfer F, Fasser MR, Widmer J, Farshad M. Interspinous and spinolaminar synthetic vertebropexy of the lumbar spine. Eur Spine J. 2023 Sep;32(9):3183-3191. doi: 10.1007/s00586-023-07798-y. Epub 2023 Jun 7.</citation>
      <PMID>37284900</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>degenerative lumbar spinal disease</keyword>
    <keyword>decompression</keyword>
    <keyword>fusion</keyword>
    <keyword>vertebropexy</keyword>
    <keyword>ligamentous fixation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Stenosis</mesh_term>
      <mesh_term>Spinal Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The investigators affirm and uphold the principle of the participant's right to privacy and that they shall comply with applicable privacy laws. Especially, anonymity of the participants shall be guaranteed when presenting the data at scientific meetings or publishing them in scientific journals.&#xD;
  Individual subject medical information obtained as a result of this study is considered confidential and disclosure to third parties is prohibited. Subject confidentiality will be further ensured by utilising subject identification code numbers to correspond to treatment data in the computer files.&#xD;
  For data verification purposes, authorised representatives of the Sponsor (-Investigator), a competent authority (e.g. Swissmedic), or an ethics committee may require direct access to parts of the medical records relevant to the study, including participants' medical history.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024785
  org study id: VPRCT
  nct id: NCT06024785
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To assess the need for additional fusion surgery versus the risk of a revision surgery in
        patients with degenerative lumbar spinal disease and to assess efficacy and risk of a new
        ligamentous fixation technique (vertebropexy)
  The global share of people over the age of 65 years has been consistently on the rise over
        the past few decades, and is still projected to increase. The increasing life expectancy,
        overall advances in medical care and therefore, the higher average age of people seeking
        surgical treatment lead to increasing numbers of spine surgeries: Spinal fusion is one of the
        most frequently used surgical treatment modalities for spinal disorders with 7.6 million per
        year worldwide (EU: 700,000, USA: 450,000, CH: 9000) and provides stability by internal rigid
        fixation of the spine with screws, rods and bony fusion. Although producing reliable
        short-term results with rapid pain relief and positive effects on patient outcome,
        implant-related complications, painful pseudarthrosis (non-union of bone), screw loosening,
        and adjacent segment disease lead to one-third of patients requiring reoperation within 15
        years. These complications might be evoked by altered biomechanics with redistribution of
        loads and subsequently increased stress at the bone-implant interface as well as long fusions
        leading to relevant, irreversible loss of motion. Therefore, a new treatment modality which
        reinforces bony spinal segments with ligaments, the so called "vertebropexy", was recently
        developed by Farshad et al. The goal is to achieve targeted stabilization of the spine by
        inserting ligamentous allografts to counteract instability, without immobilizing the segment.
        Furthermore, it might provide additional stabilization after decompression surgery and
        therefore reduce revision surgery rates due to instability in clinically relevant directions
        as flexion-extension or anterior shear stress. However, to become a broadly accepted surgical
        alternative to existing surgical techniques for degenerative lumbar spinal disease like
        dorsal fusion and spinal decompression surgery, the new technique must provide convincing
        long-term results superior to those of these established procedures which is the primary
        objective of this randomized controlled trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Stratification: Indication for decompression (study arm 1) or fusion (study arm 2)
  Randomization within study arm 1 and study arm 2 between study intervention and control intervention
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: There is no blinding.
  measure: ODI (Oswestry Disability Index)
  time frame: 2 years postoperative
  description: To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery
  measure: VAS (Visual Analogue Scale)
  time frame: 2 years postoperative
  description: To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery. VAS scale 0-10, 10 meaning the highest pain score and 0 no pain at all.
  measure: SSM symptoms/function (Spinal Stenosis Measure)
  time frame: 2 years postoperative
  description: To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery
  measure: SSM satisfaction (Spinal Stenosis Measure)
  time frame: 2 years postoperative
  description: To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery
  measure: EQ-5D (European Quality of Life Five Dimension)
  time frame: 2 years postoperative
  description: To assess and compare the clinical outcome of patients with spinal canal stenosis or foraminal stenosis +/- degenerative listhesis with either vertebropexy, decompression or fusion surgery
  measure: Revision surgery
  time frame: 2 years postoperative
  description: surgery on same and/or on adjacent levels
  measure: Complications
  time frame: 2 years postoperative
  description: - intraoperative: lesion of nerve root, dural tear, lesion of vessels
  - postoperative: surgical site infection, wound healing disorder, hematoma, paresis, material loosening (with fusion), material failure (with fusion), pseudarthrosis (with fusion), fracture, allograft tendon rupture (with vertebropexy)
  - non-surgical: anesthesiological, cardiovascular, pulmonal, thromboembolic, death
  measure: Duration of surgery
  time frame: Perioperative
  description: Duration of intervention in minutes
  measure: Length of hospital stay
  time frame: Perioperative
  description: Duration of hospital stay in days
  measure: Intraoperative blood loss
  time frame: Perioperative
  description: Blood loss intraoperative in ml
  measure: Use of analgesia
  time frame: 2 years postoperative
  description: Intake of analgetics
  measure: Use of physical therapy
  time frame: 2 years postoperative
  description: Necessity to undergo further physical therapy (for instance due to remaining pain or function deficit)
  arm group label: Indication for decompression, randomization for decompression
  arm group type: Active Comparator
  description: microsurgical lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures; approach: bilateral or ipsilateral with cross-over to the contralateral side
  arm group label: Indication for decompression, randomization for vertebropexy
  arm group type: Experimental
  description: microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side.
  Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft), which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.
  arm group label: Indication for fusion, randomization for fusoin
  arm group type: Active Comparator
  description: decompression and posterolateral instrumented fusion (arthrodesis) with implantation of pedicle screws, titanium alloy rods across the level of listhesis, an intervertebral fusion device and local autograft as well as DBX (demineralized bone matrix) to improve bony fusion
  arm group label: Indication for fusion, randomization for vertebropexy
  arm group type: Experimental
  description: microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side.
  Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft) which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.
  intervention type: Procedure
  intervention name: Vertebropexy
  description: microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side.
  Stabilization of the spine will be achieved with a biological ligament (for instance semitendinosus donor allograft) which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.
  arm group label: Indication for decompression, randomization for decompression
  arm group label: Indication for decompression, randomization for vertebropexy
  arm group label: Indication for fusion, randomization for fusoin
  arm group label: Indication for fusion, randomization for vertebropexy
  other name: ligamentous fixation of the spine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mazda Farshad, MD
  phone: +413861111
  email: Mazda.Farshad@balgrist.ch
  last name: Sabrina Catanzaro, RN
  phone: +413861111
  email: Sabrina.Catanzaro@balgrist.ch
  facility: 
  contact: 
  country: Switzerland
  citation: Widmer J, Cornaz F, Scheibler G, Spirig JM, Snedeker JG, Farshad M. Biomechanical contribution of spinal structures to stability of the lumbar spine-novel biomechanical insights. Spine J. 2020 Oct;20(10):1705-1716. doi: 10.1016/j.spinee.2020.05.541. Epub 2020 May 28.
  PMID: 32474224
  citation: Farshad M, Tsagkaris C, Widmer J, Fasser MR, Cornaz F, Calek AK. Vertebropexy as a semi-rigid ligamentous alternative to lumbar spinal fusion. Eur Spine J. 2023 May;32(5):1695-1703. doi: 10.1007/s00586-023-07647-y. Epub 2023 Mar 17.
  PMID: 36930387
  citation: Calek AK, Widmer J, Fasser MR, Farshad M. Lumbar vertebropexy after unilateral total facetectomy. Spine J. 2023 Jul 13:S1529-9430(23)03259-X. doi: 10.1016/j.spinee.2023.07.005. Online ahead of print.
  PMID: 37451550
  citation: Calek AK, Altorfer F, Fasser MR, Widmer J, Farshad M. Interspinous and spinolaminar synthetic vertebropexy of the lumbar spine. Eur Spine J. 2023 Sep;32(9):3183-3191. doi: 10.1007/s00586-023-07798-y. Epub 2023 Jun 7.
  PMID: 37284900
  responsible party type: Sponsor
  mesh term: Spinal Stenosis
  mesh term: Spinal Diseases
  sharing ipd: No
  ipd description: The investigators affirm and uphold the principle of the participant's right to privacy and that they shall comply with applicable privacy laws. Especially, anonymity of the participants shall be guaranteed when presenting the data at scientific meetings or publishing them in scientific journals.
  Individual subject medical information obtained as a result of this study is considered confidential and disclosure to third parties is prohibited. Subject confidentiality will be further ensured by utilising subject identification code numbers to correspond to treatment data in the computer files.
  For data verification purposes, authorised representatives of the Sponsor (-Investigator), a competent authority (e.g. Swissmedic), or an ethics committee may require direct access to parts of the medical records relevant to the study, including participants' medical history.