CompletedNot Applicable

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

South Korea87 participantsStarted 2011-10-11

Plain-language 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.

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 medic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT04688281

SponsorShin Poong Pharmaceutical Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03-25

View on ClinicalTrials.gov More Intervertebral Disc Disorder trials