Clinical trial NCT04688281: Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)
Official title: Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ Multicenter, Randomized, Evaluator-blind, Parallel-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervertebral Disc Disorder
Thoracic Intervertebral Disc Disorders
Thoracolumbar Intervertebral Disc Disorders
Lumbosacral Intervertebral Disc Disorders
Tissue Adhesion, Surgery-Induced
Keywords: Medicurtain®
Sodium hyaluronate
Hydroxyethylstarch
Anti-adhesion barrier
Lead sponsor: Shin Poong Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-29
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Aged between 20 \~ 70 years old
* Subject who is reserved with surgery for single-level or unilateral herniated lumbar Intervertebral disc
* Subject who is scheduled for In Situ Decompression(laparoscopic hysterectomy)
* Subject who does not respond to non-surgical treatment for at least past 6 weeks or require emergency surgery due to neural paralysis or excruciating pain
* Subject or his or her legal representative who signed and informed consent

Exclusion Criteria:

* Subject with multi-level or far lateral herniated lumbar intervertebral disc
* Subject with degenerative spinal disease or scoliosis
* Subject requires spinal fusion surgery
* Subject with severe liver or kidney disease
* Subject with lymph fluid or blood coagulation disease or medicated with blood clotting drug.
* Subject on oral or non-oral anti-diabetic drug or hypoglycemic drug
* Subject with suppressed immunity or autoimmune disease
* Subject with severe systemic disease
* Subject with infectious disease or healing disorder that may prevent normal healing process after surgery.
* Subject contraindicated with MRI scanning.
* Pregnant or lactating women
* Subject participated in other clinical trial within 30 days prior to the trial
* Subject justified not eligible to participate in the trial by Investigator

  * Subject undergone previous spinal surgery
  * Subject treated steroid epidural injection within 2 weeks or take oral steroid within 24 hours after surgery
  * Subject medicated aspirin or non-steroid anti-inflammatory drug within 7 days after surgery
  * Subject received myelogram or lumbar puncture within 24 hours after surgery

Primary outcomes:
measure: Comparison of the average score of total MRI scar score evaluated by the independent evaluator after 12 weeks of the index surgery.
timeFrame: Week 12
Secondary outcomes:
measure: Comparison of the highest score of total MRI scar score evaluated by the independent evaluator after 12 weeks of the index surgery.
timeFrame: Week 12
measure: Comparison of Oswestry Disability Index (ODI) final score for overall satisfaction with the surgery
timeFrame: Week 12
measure: Comparison of Visual Analog Scale (VAS) score for overall satisfaction with the surgery
timeFrame: Week 12
Other outcomes:
measure: The incidence rate of adverse events
timeFrame: follow up to 12 weeks
measure: The incidence rate of treatment-emergent adverse event (TEAE)
timeFrame: follow up to 12 weeks
measure: The incidence rate of adverse device event
timeFrame: follow up to 12 weeks
measure: The incidence rate of serious adverse events
timeFrame: follow up to 12 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu, Ilwon-dong 50
Study officials:
affiliation: Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea
name: Chong-Suh Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea
name: Eun-Sang Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee University Hospital, Gangdong-gu, Sangil-dong 149, Seoul, South Korea
name: Ki-Tack Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea
name: Joomyung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Medical Center, Pyeongchon-dong 896, Anyang, Gyeonggi-do, South Korea
name: Yong Cheol Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital , Jongro-gu, Yeongeon-dong, Seoul, South Korea
name: Bong-Soon Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital , Yongsan-gu, Daesagwan-ro 59, Seoul, South Korea
name: Byung-Joon Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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