Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)

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.

Conditions

• Intervertebral Disc Disorder
• Thoracic Intervertebral Disc Disorders
• Thoracolumbar Intervertebral Disc Disorders
• Lumbosacral Intervertebral Disc Disorders
• Tissue Adhesion, Surgery-Induced

Interventions

DEVICE

Medicurtain®

Medicurtain® 5ml prefilled syringe

DEVICE

GUARDIX-SG®

GUARDIX-SG® 5ml prefilled syringe

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.

  lead INDUSTRY

Principal Investigators

• Chong-Suh Lee, MD, PhD · Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea

• Eun-Sang Kim, MD, PhD · Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea

• Ki-Tack Kim, MD, PhD · Kyung Hee University Hospital, Gangdong-gu, Sangil-dong 149, Seoul, South Korea

• Joomyung Kim, MD, PhD · Samsung Medical Center, Gangnam-gu, Ilwon-dong 50, Seoul, South Korea

• Yong Cheol Yoon, MD, PhD · Hallym University Medical Center, Pyeongchon-dong 896, Anyang, Gyeonggi-do, South Korea

• Bong-Soon Chang, MD, PhD · Seoul National University Hospital , Jongro-gu, Yeongeon-dong, Seoul, South Korea

• Byung-Joon Shin, MD, PhD · Soonchunhyang University Hospital , Yongsan-gu, Daesagwan-ro 59, Seoul, South Korea

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-11

Primary Completion

2013-03-25

Completion

2013-03-25

Countries

• South Korea

Study Locations