Intervertebral Disc DisorderNCT04688281
Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)
A study testing Medicurtain® and GUARDIX-SG® in people with Intervertebral Disc Disorder and Thoracic Intervertebral Disc Disorders, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Intervertebral Disc Disorder, Thoracic Intervertebral Disc Disorders, Thoracolumbar Intervertebral Disc Disorders
- What is being tested?
- Medicurtain® and GUARDIX-SG®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2011to 25 Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ Multicenter, Randomized, Evaluator-blind, Parallel-controlled Trial
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.
Read the 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.
- Conditions
- Intervertebral Disc Disorder, Thoracic Intervertebral Disc Disorders, Thoracolumbar Intervertebral Disc Disorders, Lumbosacral Intervertebral Disc Disorders, Tissue Adhesion, Surgery-Induced
- Being tested
- Medicurtain®, GUARDIX-SG®
- Keywords
- Medicurtain®, Sodium hyaluronate, Hydroxyethylstarch, Anti-adhesion barrier
- Medical subject headings
- Intervertebral disc disease, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicurtain®Device
Medicurtain® 5ml prefilled syringe
GUARDIX-SG®Device
GUARDIX-SG® 5ml prefilled syringe
| Study group | Role | What they receive |
|---|---|---|
| GUARDIX-SG® | Active comparator | Treat GUARDIX-SG 5ml prefilled syringe after surgery Receives: Device: GUARDIX-SG® |
| Medicurtain® | Experimental | Treat Medicurtain® 5ml prefilled syringe after surgery Receives: Device: Medicurtain® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the average score of total MRI scar score evaluated by the independent evaluator after 12 weeks of the index surgery.
The intervertebral disc is divided into 5 consecutive axial sections and these 5 levels are divided into quadrant. Degree of peridural fibrosis is scaled by scar grading scale in 0~4 point range. (Total 20 score system)
*Area of quadrant filled with scar: no scar = 0 point, 0%~25% = 1 point, 25%~50% = 2 point, 50%~75% = 3 point, 75%~100% = 4 point
Measured: Week 12
Secondary outcomes (3)
Comparison of the highest score of total MRI scar score evaluated by the independent evaluator after 12 weeks of the index surgery.
The intervertebral disc is divided into 5 consecutive axial sections and these 5 levels are divided into quadrant. Degree of peridural fibrosis is scaled by scar grading scale in 0~4 point range. (Total 20 score system)
*Area of quadrant filled with scar: no scar = 0 point, 0%~25% = 1 point, 25%~50% = 2 point, 50%~75% = 3 point, 75%~100% = 4 point
Measured: Week 12
Comparison of Oswestry Disability Index (ODI) final score for overall satisfaction with the surgery
The Oswestry Low Back Pain Disability Index (ODI) ODI Version 2.0 measure disability and quality of life in individuals with low back pain (LBP). It consists of questions related to Activities of Daily Living (ADLs) and pain, and is measured on a scale of 0-5 points for every 10 sections
Measured: Week 12
Comparison of Visual Analog Scale (VAS) score for overall satisfaction with the surgery
The severity of pain was evaluated using a visual analogue scale (VAS). The participants were requested to put a line on the scale perpendicularly that matched to their pain intensity. VAS scores (0-100) represent the pain intensity as none, mild, moderate, or severe
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start11 Oct 2011
- Primary completion25 Mar 2013
- Study completion25 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chong-Suh Lee, MD, PhD, Principal investigator, Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South KoreaEun-Sang Kim, MD, PhD, Principal investigator, Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South KoreaKi-Tack Kim, MD, PhD, Principal investigator, Kyung Hee University Hospital, Gangdong-gu, Sangil-dong 149, Seoul, South KoreaJoomyung Kim, MD, PhD, Principal investigator, Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South KoreaYong Cheol Yoon, MD, PhD, Principal investigator, Hallym University Medical Center, Pyeongchon-dong 896, Anyang, Gyeonggi-do, South KoreaBong-Soon Chang, MD, PhD, Principal investigator, Seoul National University Hospital , Jongro-gu, Yeongeon-dong, Seoul, South KoreaByung-Joon Shin, MD, PhD, Principal investigator, Soonchunhyang University Hospital , Yongsan-gu, Daesagwan-ro 59, Seoul, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688281
- Sponsor's protocol ID
- UMT2011-SP-MC-03
- Status last verified
- Sep 2021
- First submitted
- 23 Dec 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ Multicenter, Randomized, Evaluator-blind, Parallel-controlled Trial
- ClinicalTrials.gov ID
- NCT04688281
- Acronym / sponsor ID
- UMT2011-SP-MC-03
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2011 (actual)
- Primary completion
- 25 Mar 2013 (actual)
- Study completion
- 25 Mar 2013 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GUARDIX-SG® | Active comparator | Device: GUARDIX-SG®Treat GUARDIX-SG 5ml prefilled syringe after surgery |
| Medicurtain® | Experimental | Device: Medicurtain®Treat Medicurtain® 5ml prefilled syringe after surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicurtain®Medicurtain® 5ml prefilled syringe | Device | Medicurtain® |
| GUARDIX-SG®GUARDIX-SG® 5ml prefilled syringe | Device | GUARDIX-SG® |
Primary outcome
Comparison of the average score of total MRI scar score evaluated by the independent evaluator after 12 weeks of the index surgery.
Time frame: Week 12
The intervertebral disc is divided into 5 consecutive axial sections and these 5 levels are divided into quadrant. Degree of peridural fibrosis is scaled by scar grading scale in 0~4 point range. (Total 20 score system) *Area of quadrant filled with scar: no scar = 0 point, 0%~25% = 1 point, 25%~50% = 2 point, 50%~75% = 3 point, 75%~100% = 4 point
3 secondary outcomes
Comparison of the highest score of total MRI scar score evaluated by the independent evaluator after 12 weeks of the index surgery.
Time frame: Week 12
Comparison of Oswestry Disability Index (ODI) final score for overall satisfaction with the surgery
Time frame: Week 12
Comparison of Visual Analog Scale (VAS) score for overall satisfaction with the surgery
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chong-Suh Lee, MD, PhD principal investigator
Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea
Eun-Sang Kim, MD, PhD principal investigator
Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea
Ki-Tack Kim, MD, PhD principal investigator
Kyung Hee University Hospital, Gangdong-gu, Sangil-dong 149, Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicurtain® and GUARDIX-SG® in people with Intervertebral Disc Disorder and Thoracic Intervertebral Disc Disorders, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the average score of total MRI scar score evaluated by the independent evaluator after 12 weeks of the index surgery. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.