<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/NCT03250611</url>
  </required_header>
  <id_info>
    <org_study_id>OC.Screw</org_study_id>
    <nct_id>NCT03250611</nct_id>
  </id_info>
  <brief_title>Occipito-Cervical Stabilization Using Occipital Condyle Screw</brief_title>
  <official_title>Occipito-Cervical Stabilization Using Occipital Condyle as a Cranial Anchor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      The Occipito-Cervical (OC) junction is the most cephalad portion of the spinal axis, with&#xD;
      anatomical osseous complex that allows significant mobility while maintaining biomechanical&#xD;
      stability. OC instability is a rare disorder with potentially life-threatening consequences.&#xD;
      Instability may manifest as disabling pain, cranial nerve dysfunction, paralysis, or even&#xD;
      sudden death. The most common acute presentation is secondary to major trauma. Other&#xD;
      pathologic processes that may lead to chronic instability include rheumatoid arthritis,&#xD;
      infections, tumors, and even congenital malformations; OC fusion in aforementioned cases each&#xD;
      according is then indicated.&#xD;
&#xD;
      Stabilization of the OC junction remains a challenge, owing to the regional anatomy and poor&#xD;
      occipital bone purchase. OC stabilization techniques have undergone continuous refinement.&#xD;
      Early techniques involving simple posterior only bone grafts demonstrated a high rate of&#xD;
      failure and have largely been replaced by rigid posterior fixation systems using rods/screws&#xD;
      or plates, providing superior biomechanical stability and higher rates of fusion. One of the&#xD;
      very modern modalities of fixation methods is the Occipital Condyle Screw (OCS) as a sole&#xD;
      cranial anchor; believing that decreasing the length of lever arm of the construct,&#xD;
      increasing the length of the screw purchase, and decreasing stresses addressed on the rod&#xD;
      with no need to excessively bend it for the occipital slope may enhance the construct&#xD;
      rigidity, and leaving a greater clear metal-free area of the occiput for graft contact may&#xD;
      have a real potential benefits in fusion rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical Evaluation: of patients with 1- Visual Analogue Scale (VAS), 2- Neck Disability&#xD;
      Index (NDI), 3- Modified Japanese Orthopaedic Association Cervical Myelopathy Score&#xD;
      (mJOA.CMS), 4- American Spinal Injury Association Score (ASIAs). Immediate preoperative&#xD;
      functional scoring, and 6 weeks, 3 months, 6 months, and 1 year postoperative.&#xD;
&#xD;
      Surgical Technique: The patient is handled in prone position after successful general&#xD;
      anaesthesia with supported head to ensure that the Occipito-Cervical junction maintains in&#xD;
      neutral position. The Occipito-Cervical junction is then exposed through a traditional&#xD;
      midline longitudinal posterior skin incision extends from the external occipital protuberance&#xD;
      to the C3-C4 level. The nuchal ligament is divided in the midline, and the occipital and&#xD;
      cervical musculature is dissected subperiosteally. The suboccipital and cervical paraspinous&#xD;
      muscles are retracted laterally to expose the underlying bony architecture. The posterior&#xD;
      arch of C1 is exposed and the dissection is continued laterally in a subperiosteal manner to&#xD;
      identify the horizontal segment of the vertebral arteries (VAs) which is enveloped in a dense&#xD;
      venous plexus. The atlanto-occipital joint capsule is to be approx. 3 mm. Cranial to the&#xD;
      superior margin of tht VA. Attention is then focused on the foramen magnum. Using curettes,&#xD;
      the atlanto-occipital membrane is gently dissected from the foramen magnum laterally until&#xD;
      the medial aspect of the occipital condyle is reached. At this point, the dissection&#xD;
      continues laterally, maintaining bone contact to prevent injury to the horizontal segment of&#xD;
      the VA along the condylar fossa, until the posterior condylar foramen and emissary vein are&#xD;
      identified. The condylar foramen and vein represent the lateral extent of the dissection. At&#xD;
      this stage, the operative field is prepared for instrumentation. Inserting the cervical&#xD;
      screws first provides useful information about the axial location of the occipital condyles.&#xD;
      The condylar entry point (CEP) is defined using a combination of radiographic and anatomic&#xD;
      landmarks. The CEP is located (4 to 5 mm) lateral to the posteromedial edge of the condyle,&#xD;
      and (2 mm) above the atlanto-occipital joint line. Pilot hole is then made at the entry point&#xD;
      using an awl with slight cranial angulation to avoid injury to the horizontal segment of the&#xD;
      VA. The pilot hole is then drilled under image-guidance in a convergent trajectory with (12&#xD;
      to 22 degrees) of medial angulation and (5 degrees) cranial angulation in the sagittal plane&#xD;
      with the tip of the drill directed toward the basion, advancing slowly until the anterior&#xD;
      cortical edge of the condyle is breached. The hole is tapped, and a (3.5 mm) polyaxial screw&#xD;
      of an appropriate length (30 to 34 mm) is inserted bicortically into the occipital condyle.&#xD;
      Approximately (12 mm) portion of the screw remains superficial to the posterior cortex of the&#xD;
      condyle, allowing the polyaxial portion of the screw to lie above the posterior arch of C1,&#xD;
      minimizing any chance of irritation of the VA by the rods.&#xD;
&#xD;
      Radiological Evaluation: 1- Preoperative: Plain X-ray (PXR) Antero-posterior (AP) and Lateral&#xD;
      (Lat.) views to study the upper cervical instability indices and measurements, Multi-Slice&#xD;
      Computed Tomography (MSCT) to study the boney Occipito-Cervical architecture for any&#xD;
      fractures or anomalies, CT Angiography (CTA) to study the vertebral artery for anomaly&#xD;
      especially in the horizontal segment of the VA, and Magnetic Resonance Imaging (MRI) to study&#xD;
      the spinal cord for any compression signs. 2- Postoperative: Immediate (PXR) AP. and Lat.&#xD;
      views for overall global assessment of the reduction and the construct installation. Then at&#xD;
      3 months, 6 months, and 1 year after surgery with flexion extension lateral view bending&#xD;
      stress films for assessment of stability. Immediate (MSCT) to study the crucial screws&#xD;
      placement estate for any breaches or successfulness, and after 1year for assessment of the&#xD;
      fusion rate achieved.&#xD;
&#xD;
      Serial Follow-Up: after 6 weeks for clinical evaluation and functional scoring. At 3 and 6&#xD;
      months for radiological evaluation of stability, clinical evaluation and functional&#xD;
      re-scoring. At 1 year for evaluation of fusion rate, clinical evaluation and over all&#xD;
      resultant functional scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CT based classification for assessment of biological graft fusion</measure>
    <time_frame>At 6 months postoperative</time_frame>
    <description>A new assessment method of bony union using high-speed spiral CT imaging is proposed which reflects the gradually increasing biological stability of the construct. Grade I (complete fusion) implies cortical union of the allograft and central trabecular continuity. Grade II (partial fusion) implies cortical union of the structural allograft with partial trabecular incorporation. Grade III (unipolar pseudarthrosis) denotes superior or inferior cortical non-union of the central allograft with partial trabecular discontinuity centrally and Grade IV (bipolar pseudarthrosis) suggests both superior and inferior cortical non-union with a complete lack of central trabecular continuity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale for Pain (VAS Pain)</measure>
    <time_frame>Baseline measure, then at 2 weeks, 3 months and 6 months postoperative</time_frame>
    <description>Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>Baseline measure, then at 2 weeks, 3 months and 6 months postoperative</time_frame>
    <description>Each of 10 items, which are 1. Pain intensity 2. Personal care 3. Lifting 4. Reading 5. Headaches 6. Concentration 7. Work 8. Driving 9. Sleeping 10. Recreation, is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Occasionally, a respondent will not complete one question or another. The average of all other items is then added to the completed items.&#xD;
The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability, 5 - 14 = mild, 15 - 24 = moderate, 25 - 34 = severe, and above 34 = complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Spinal Injury Association Score (ASIAs)</measure>
    <time_frame>Baseline and 3 months postoperative</time_frame>
    <description>A score developed by the American Spinal Injury Association for essential minimal elements of neurologic assessment for all patients with a spinal injury.&#xD;
(A). Complete loss of motor and sensory function below the level of injury, including the anal saddle shaped area.&#xD;
(B). Spared all/some sensory function below the level of injury, including the anal saddle shaped area.&#xD;
(C). Spared all/some motor function below the level of injury, but cannot move against gravity.&#xD;
(D). Spared all/some motor function below the level of injury, with ability to move against gravity.&#xD;
(E). Neurologically free.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Japanese Orthopaedic Association Cervical Spondylotic Myelopathy Score (mJOA.CSM)</measure>
    <time_frame>Baseline and 3 months postoperative</time_frame>
    <description>Motor dysfunction Upper extremities&#xD;
0. Doesn't move hands&#xD;
Doesn't eat with a spoon, moves hands&#xD;
Doesn't button shirt, eats with a spoon&#xD;
Buttons shirt with great difficulty&#xD;
Buttons shirt with slight difficulty&#xD;
No dysfunction&#xD;
Motor dysfunction Lower extremities&#xD;
0. Complete loss motor &amp; sensory&#xD;
Sensory preservation, doesn't move legs&#xD;
Moves legs, doesn't walk&#xD;
Walks on flat floor with walking aid&#xD;
Walks up or downstairs w/aid of a handrail&#xD;
Moderate-to-significant lack of stability, walks up or downstairs without handrail&#xD;
Mild lack of stability, walks unaided with smooth reciprocation&#xD;
No dysfunction&#xD;
Sensory dysfunction Upper extremities&#xD;
0. Complete loss of hand sensation&#xD;
Severe sensory loss or pain&#xD;
Mild sensory loss&#xD;
No sensory loss&#xD;
Sphincter dysfunction&#xD;
0. Unable to micturate voluntarily&#xD;
Marked difficulty in micturition&#xD;
Mild-to-moderate difficulty in micturition&#xD;
Normal micturition</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cervical Instabilities Spine</condition>
  <arm_group>
    <arm_group_label>Occipito-Cervical Instability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stabilization of the occipito-cervical junction by Occipital Condyle Screw (OCS) as a sole cranial anchor, with posterior bone graft.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Occipital Condyle Screw</intervention_name>
    <description>Occipito-Cervical Screw-Rod Fixation Technique</description>
    <arm_group_label>Occipito-Cervical Instability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with occipito-cervical instability of any cause, indicated for&#xD;
             occipito-cervical fusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fractured occipital condyle&#xD;
&#xD;
          -  Congenital malformation of occipital condyle&#xD;
&#xD;
          -  Congenital anomaly of the horizontal segment of the vertebral artery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed El-Meshtawy, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Shawky, MD</last_name>
    <phone>+201010212222</phone>
    <email>ahsh313@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Muhammad Almessry, M.Sc.</last_name>
    <phone>+201007262147</phone>
    <email>dr.muhammad.orthospine@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Uribe JS, Ramos E, Vale F. Feasibility of occipital condyle screw placement for occipitocervical fixation: a cadaveric study and description of a novel technique. J Spinal Disord Tech. 2008 Dec;21(8):540-6. doi: 10.1097/BSD.0b013e31816d655e.</citation>
    <PMID>19057245</PMID>
  </reference>
  <reference>
    <citation>Uribe JS, Ramos E, Youssef AS, Levine N, Turner AW, Johnson WM, Vale FL. Craniocervical fixation with occipital condyle screws: biomechanical analysis of a novel technique. Spine (Phila Pa 1976). 2010 Apr 20;35(9):931-8. doi: 10.1097/BRS.0b013e3181c16f9a.</citation>
    <PMID>20375778</PMID>
  </reference>
  <reference>
    <citation>Uribe JS, Ramos E, Baaj A, Youssef AS, Vale FL. Occipital cervical stabilization using occipital condyles for cranial fixation: technical case report. Neurosurgery. 2009 Dec;65(6):E1216-7; discussion E1217. doi: 10.1227/01.NEU.0000349207.98394.FA.</citation>
    <PMID>19934947</PMID>
  </reference>
  <reference>
    <citation>La Marca F, Zubay G, Morrison T, Karahalios D. Cadaveric study for placement of occipital condyle screws: technique and effects on surrounding anatomic structures. J Neurosurg Spine. 2008 Oct;9(4):347-53. doi: 10.3171/SPI.2008.9.10.347.</citation>
    <PMID>18939920</PMID>
  </reference>
  <reference>
    <citation>Ahmadian A, Dakwar E, Vale FL, Uribe JS. Occipitocervical fusion via occipital condylar fixation: a clinical case series. J Spinal Disord Tech. 2014 Jun;27(4):232-6. doi: 10.1097/BSD.0b013e31825bfeea.</citation>
    <PMID>24866907</PMID>
  </reference>
  <reference>
    <citation>Tan GH, Goss BG, Thorpe PJ, Williams RP. CT-based classification of long spinal allograft fusion. Eur Spine J. 2007 Nov;16(11):1875-81. doi: 10.1007/s00586-007-0376-0. Epub 2007 May 12.</citation>
    <PMID>17497188</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 12, 2017</last_update_submitted>
  <last_update_submitted_qc>August 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Muhammad Almessry</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Occipital condyle</keyword>
  <keyword>Occipital condyle screw</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03250611
org study id: OC.Screw
nct id: NCT03250611
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Occipito-Cervical (OC) junction is the most cephalad portion of the spinal axis, with
      anatomical osseous complex that allows significant mobility while maintaining biomechanical
      stability. OC instability is a rare disorder with potentially life-threatening consequences.
      Instability may manifest as disabling pain, cranial nerve dysfunction, paralysis, or even
      sudden death. The most common acute presentation is secondary to major trauma. Other
      pathologic processes that may lead to chronic instability include rheumatoid arthritis,
      infections, tumors, and even congenital malformations; OC fusion in aforementioned cases each
      according is then indicated.

      Stabilization of the OC junction remains a challenge, owing to the regional anatomy and poor
      occipital bone purchase. OC stabilization techniques have undergone continuous refinement.
      Early techniques involving simple posterior only bone grafts demonstrated a high rate of
      failure and have largely been replaced by rigid posterior fixation systems using rods/screws
      or plates, providing superior biomechanical stability and higher rates of fusion. One of the
      very modern modalities of fixation methods is the Occipital Condyle Screw (OCS) as a sole
      cranial anchor; believing that decreasing the length of lever arm of the construct,
      increasing the length of the screw purchase, and decreasing stresses addressed on the rod
      with no need to excessively bend it for the occipital slope may enhance the construct
      rigidity, and leaving a greater clear metal-free area of the occiput for graft contact may
      have a real potential benefits in fusion rates.
Clinical Evaluation: of patients with 1- Visual Analogue Scale (VAS), 2- Neck Disability
      Index (NDI), 3- Modified Japanese Orthopaedic Association Cervical Myelopathy Score
      (mJOA.CMS), 4- American Spinal Injury Association Score (ASIAs). Immediate preoperative
      functional scoring, and 6 weeks, 3 months, 6 months, and 1 year postoperative.

      Surgical Technique: The patient is handled in prone position after successful general
      anaesthesia with supported head to ensure that the Occipito-Cervical junction maintains in
      neutral position. The Occipito-Cervical junction is then exposed through a traditional
      midline longitudinal posterior skin incision extends from the external occipital protuberance
      to the C3-C4 level. The nuchal ligament is divided in the midline, and the occipital and
      cervical musculature is dissected subperiosteally. The suboccipital and cervical paraspinous
      muscles are retracted laterally to expose the underlying bony architecture. The posterior
      arch of C1 is exposed and the dissection is continued laterally in a subperiosteal manner to
      identify the horizontal segment of the vertebral arteries (VAs) which is enveloped in a dense
      venous plexus. The atlanto-occipital joint capsule is to be approx. 3 mm. Cranial to the
      superior margin of tht VA. Attention is then focused on the foramen magnum. Using curettes,
      the atlanto-occipital membrane is gently dissected from the foramen magnum laterally until
      the medial aspect of the occipital condyle is reached. At this point, the dissection
      continues laterally, maintaining bone contact to prevent injury to the horizontal segment of
      the VA along the condylar fossa, until the posterior condylar foramen and emissary vein are
      identified. The condylar foramen and vein represent the lateral extent of the dissection. At
      this stage, the operative field is prepared for instrumentation. Inserting the cervical
      screws first provides useful information about the axial location of the occipital condyles.
      The condylar entry point (CEP) is defined using a combination of radiographic and anatomic
      landmarks. The CEP is located (4 to 5 mm) lateral to the posteromedial edge of the condyle,
      and (2 mm) above the atlanto-occipital joint line. Pilot hole is then made at the entry point
      using an awl with slight cranial angulation to avoid injury to the horizontal segment of the
      VA. The pilot hole is then drilled under image-guidance in a convergent trajectory with (12
      to 22 degrees) of medial angulation and (5 degrees) cranial angulation in the sagittal plane
      with the tip of the drill directed toward the basion, advancing slowly until the anterior
      cortical edge of the condyle is breached. The hole is tapped, and a (3.5 mm) polyaxial screw
      of an appropriate length (30 to 34 mm) is inserted bicortically into the occipital condyle.
      Approximately (12 mm) portion of the screw remains superficial to the posterior cortex of the
      condyle, allowing the polyaxial portion of the screw to lie above the posterior arch of C1,
      minimizing any chance of irritation of the VA by the rods.

      Radiological Evaluation: 1- Preoperative: Plain X-ray (PXR) Antero-posterior (AP) and Lateral
      (Lat.) views to study the upper cervical instability indices and measurements, Multi-Slice
      Computed Tomography (MSCT) to study the boney Occipito-Cervical architecture for any
      fractures or anomalies, CT Angiography (CTA) to study the vertebral artery for anomaly
      especially in the horizontal segment of the VA, and Magnetic Resonance Imaging (MRI) to study
      the spinal cord for any compression signs. 2- Postoperative: Immediate (PXR) AP. and Lat.
      views for overall global assessment of the reduction and the construct installation. Then at
      3 months, 6 months, and 1 year after surgery with flexion extension lateral view bending
      stress films for assessment of stability. Immediate (MSCT) to study the crucial screws
      placement estate for any breaches or successfulness, and after 1year for assessment of the
      fusion rate achieved.

      Serial Follow-Up: after 6 weeks for clinical evaluation and functional scoring. At 3 and 6
      months for radiological evaluation of stability, clinical evaluation and functional
      re-scoring. At 1 year for evaluation of fusion rate, clinical evaluation and over all
      resultant functional scores.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: CT based classification for assessment of biological graft fusion
time frame: At 6 months postoperative
description: A new assessment method of bony union using high-speed spiral CT imaging is proposed which reflects the gradually increasing biological stability of the construct. Grade I (complete fusion) implies cortical union of the allograft and central trabecular continuity. Grade II (partial fusion) implies cortical union of the structural allograft with partial trabecular incorporation. Grade III (unipolar pseudarthrosis) denotes superior or inferior cortical non-union of the central allograft with partial trabecular discontinuity centrally and Grade IV (bipolar pseudarthrosis) suggests both superior and inferior cortical non-union with a complete lack of central trabecular continuity.
measure: Visual Analogue Scale for Pain (VAS Pain)
time frame: Baseline measure, then at 2 weeks, 3 months and 6 months postoperative
description: Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
measure: Neck Disability Index (NDI)
time frame: Baseline measure, then at 2 weeks, 3 months and 6 months postoperative
description: Each of 10 items, which are 1. Pain intensity 2. Personal care 3. Lifting 4. Reading 5. Headaches 6. Concentration 7. Work 8. Driving 9. Sleeping 10. Recreation, is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Occasionally, a respondent will not complete one question or another. The average of all other items is then added to the completed items.
The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability, 5 - 14 = mild, 15 - 24 = moderate, 25 - 34 = severe, and above 34 = complete.
measure: American Spinal Injury Association Score (ASIAs)
time frame: Baseline and 3 months postoperative
description: A score developed by the American Spinal Injury Association for essential minimal elements of neurologic assessment for all patients with a spinal injury.
(A). Complete loss of motor and sensory function below the level of injury, including the anal saddle shaped area.
(B). Spared all/some sensory function below the level of injury, including the anal saddle shaped area.
(C). Spared all/some motor function below the level of injury, but cannot move against gravity.
(D). Spared all/some motor function below the level of injury, with ability to move against gravity.
(E). Neurologically free.
measure: Modified Japanese Orthopaedic Association Cervical Spondylotic Myelopathy Score (mJOA.CSM)
time frame: Baseline and 3 months postoperative
description: Motor dysfunction Upper extremities
0. Doesn't move hands
Doesn't eat with a spoon, moves hands
Doesn't button shirt, eats with a spoon
Buttons shirt with great difficulty
Buttons shirt with slight difficulty
No dysfunction
Motor dysfunction Lower extremities
0. Complete loss motor & sensory
Sensory preservation, doesn't move legs
Moves legs, doesn't walk
Walks on flat floor with walking aid
Walks up or downstairs w/aid of a handrail
Moderate-to-significant lack of stability, walks up or downstairs without handrail
Mild lack of stability, walks unaided with smooth reciprocation
No dysfunction
Sensory dysfunction Upper extremities
0. Complete loss of hand sensation
Severe sensory loss or pain
Mild sensory loss
No sensory loss
Sphincter dysfunction
0. Unable to micturate voluntarily
Marked difficulty in micturition
Mild-to-moderate difficulty in micturition
Normal micturition
arm group label: Occipito-Cervical Instability
arm group type: Experimental
description: Stabilization of the occipito-cervical junction by Occipital Condyle Screw (OCS) as a sole cranial anchor, with posterior bone graft.
intervention type: Procedure
intervention name: Occipital Condyle Screw
description: Occipito-Cervical Screw-Rod Fixation Technique
arm group label: Occipito-Cervical Instability
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Mohamed El-Meshtawy, MD
role: Study Director
affiliation: Assiut University
last name: Ahmed Shawky, MD
phone: +201010212222
email: ahsh313@yahoo.com
last name: Muhammad Almessry, M.Sc.
phone: +201007262147
email: dr.muhammad.orthospine@gmail.com
citation: Uribe JS, Ramos E, Vale F. Feasibility of occipital condyle screw placement for occipitocervical fixation: a cadaveric study and description of a novel technique. J Spinal Disord Tech. 2008 Dec;21(8):540-6. doi: 10.1097/BSD.0b013e31816d655e.
PMID: 19057245
citation: Uribe JS, Ramos E, Youssef AS, Levine N, Turner AW, Johnson WM, Vale FL. Craniocervical fixation with occipital condyle screws: biomechanical analysis of a novel technique. Spine (Phila Pa 1976). 2010 Apr 20;35(9):931-8. doi: 10.1097/BRS.0b013e3181c16f9a.
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citation: Uribe JS, Ramos E, Baaj A, Youssef AS, Vale FL. Occipital cervical stabilization using occipital condyles for cranial fixation: technical case report. Neurosurgery. 2009 Dec;65(6):E1216-7; discussion E1217. doi: 10.1227/01.NEU.0000349207.98394.FA.
PMID: 19934947
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PMID: 18939920
citation: Ahmadian A, Dakwar E, Vale FL, Uribe JS. Occipitocervical fusion via occipital condylar fixation: a clinical case series. J Spinal Disord Tech. 2014 Jun;27(4):232-6. doi: 10.1097/BSD.0b013e31825bfeea.
PMID: 24866907
citation: Tan GH, Goss BG, Thorpe PJ, Williams RP. CT-based classification of long spinal allograft fusion. Eur Spine J. 2007 Nov;16(11):1875-81. doi: 10.1007/s00586-007-0376-0. Epub 2007 May 12.
PMID: 17497188
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Muhammad Almessry
investigator title: Principal investigator
sharing ipd: No