Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)
Condition: Intervertebral Disc Disorder; Thoracic Intervertebral Disc Disorders; Thoracolumbar Intervertebral Disc Disorders; Lumbosacral Intervertebral Disc Disorders; Tissue Adhesion, Surgery-Induced
MeSH terms: Spinal Diseases; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Tissue Adhesions
Study type: Interventional

Summary: 
      This study was designed to evaluate the efficacy and safety of Medicurtain®, an antiadhesion
      barrier in patients who underwent In Situ Decompression for single level and unilateral
      herniated lumbar intervertebral disc. Subjects were randomly assigned either into
      Medicurtain® treatment group or control group. Adhesion formations between the two groups at
      12 weeks after surgery were compared by using MRI-applied scar score, ODI (Oswestry
      Disability Index) and VAS.
    

Detailed description: 
      This study was multicenter, randomized, evaluator-blind, parallel-controlled trial. A subject
      aged between 20~70 years old who was reserved for In Situ Decompression for single level and
      unilateral herniated lumbar intervertebral disc considered to be eligible for study entry.
      Subject screening was conducted at Visit 1 (screening period) to determine study based on the
      results of the examination for the spine surgery. Subject who met the inclusion/exclusion
      criteria were randomly assigned into either the treatment and control group at Visit 2
      (Baseline: 0day) and received the defined treatment according to the protocol.

      Direct evaluation of the level of adhesion around surgical area was analyzed by measuring
      peridural fibrosis and scar score through MRI (Total MRI scar score). Jeffrey S. Ross et al.
      reported that in evaluating scar in disc region, MR has been used by many researchers and
      shows 96% accuracy in identifying scar in disc region. Also measuring the level of fibrosis
      in surgical wounds through MRI scar score has already been widely used in many large-scale
      studies and shows almost perfect conformity degree I inter-and intra-observer reading
      results.

      Therefore based on literatures, this study measures the level of adhesion in surgical wounds
      through MRI scar score, which has been validated and widely used in similar studies. Using
      MRI 3 months after surgery, the level of scar in lumbar spinal column is evaluated. All MRI
      images should be evaluated by one radiologist unless the randomization of the treatment group
      and control group is revealed. Peridural fibrosis is evaluated on the improved and unimproved
      state of axial T1-weighted image contrast. In MR image evaluation, location of peridural
      fibrosis to 5 consecutive axial sections that are 4mm thick around the intervertebral disc is
      recorded; these 5 levels are divided into quadrant which are divided by 2 straight lines
      vertical to the center of thecal sac.

      Degree of peridural fibrosis is scaled by scar grading scale in 0~4 point range according to
      the dimension of the quadrant filled with scar. Record the scar score of each quadrant of 5
      levels (total of 20 grades-scar score method). The measured scar scores of the
      investigational device group and control device group are compared and evaluated with total
      of 20 scores on each quadrant of 5 levels (Total MRI score).

      After 2 weeks (2 weeks±3days) of the index surgery, following tests were performed to
      evaluate the subject's condition and adverse events at before signing on the informed consent
      and after the surgery. The investigation device is composed of mainly Sodium Hyaluronate(HA)
      and Hydroxyethylstarch(HES) which were degraded in the liver and excreted from the kidney,
      therefore, it is included liver and kidney function test and blood coagulation test since
      abnormal function of blood coagulation can increase adhesion around the surgical wound area.
    

Intervention name(s): Medicurtain®; GUARDIX-SG®
Intervention type(s): Device; Device
Intervention description(s): Medicurtain® 5ml prefilled syringe; GUARDIX-SG® 5ml prefilled syringe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Medicurtain®; Sodium hyaluronate; Hydroxyethylstarch; Anti-adhesion barrier