Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)
1 other identifier
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2013
CompletedFirst Submitted
Initial submission to the registry
December 23, 2020
CompletedFirst Posted
Study publicly available on registry
December 29, 2020
CompletedSeptember 29, 2021
September 1, 2021
1.5 years
December 23, 2020
September 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
Week 12
Comparison of Oswestry Disability Index (ODI) final score for overall satisfaction with the surgery
Week 12
Comparison of Visual Analog Scale (VAS) score for overall satisfaction with the surgery
Week 12
Other Outcomes (4)
The incidence rate of adverse events
follow up to 12 weeks
The incidence rate of treatment-emergent adverse event (TEAE)
follow up to 12 weeks
The incidence rate of adverse device event
follow up to 12 weeks
- +1 more other outcomes
Study Arms (2)
GUARDIX-SG®
ACTIVE COMPARATORTreat GUARDIX-SG 5ml prefilled syringe after surgery
Medicurtain®
EXPERIMENTALTreat Medicurtain® 5ml prefilled syringe after surgery
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Gangnam-gu, Ilwon-dong 50, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chong-Suh Lee, MD, PhD
Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea
- PRINCIPAL INVESTIGATOR
Eun-Sang Kim, MD, PhD
Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea
- PRINCIPAL INVESTIGATOR
Ki-Tack Kim, MD, PhD
Kyung Hee University Hospital, Gangdong-gu, Sangil-dong 149, Seoul, South Korea
- PRINCIPAL INVESTIGATOR
Joomyung Kim, MD, PhD
Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea
- PRINCIPAL INVESTIGATOR
Yong Cheol Yoon, MD, PhD
Hallym University Medical Center, Pyeongchon-dong 896, Anyang, Gyeonggi-do, South Korea
- PRINCIPAL INVESTIGATOR
Bong-Soon Chang, MD, PhD
Seoul National University Hospital , Jongro-gu, Yeongeon-dong, Seoul, South Korea
- PRINCIPAL INVESTIGATOR
Byung-Joon Shin, MD, PhD
Soonchunhyang University Hospital , Yongsan-gu, Daesagwan-ro 59, Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2020
First Posted
December 29, 2020
Study Start
October 11, 2011
Primary Completion
March 25, 2013
Study Completion
March 25, 2013
Last Updated
September 29, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share