Herniation, Disc
Conditions
Keywords
disc herniation, laminectomy, anti-adhesion, disc resection, MegaShield, MegaShield-SP
Brief summary
This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied.
Detailed description
To evaluate preventing adhesion, the study group is compared with MegaShield®-SP or Guardix-SP Plus after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 weeks to conduct examinations and assess Questionnaires.
Interventions
DEVICEMegaShield®-SP
MegaShield®-SP application Lumbar discectomy or laminectomy
DEVICEGuardix-SP Plus
Guardix-SP Plus application Lumbar discectomy or laminectomy
Sponsors
L&C Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 20 to 70 years. * Patient diagnosed with single-level lumbar disc herniation and scheduled to perform Lumbar discectomy, or patients diagnosed with single-level spinal stenosis and scheduled to perform laminectomy. * Patients who voluntarily decide to participate in the study and voluntarily agree in writing to the informed consent form.
Exclusion criteria
* Patients diagnosed with multi-level lumbar disc herniation or lumbar disectomy ,far lateral lumbar disc herniation(FLLDH). * Patient diagnosed with spinal cord disease * Patient who needs spinal fusion * Patient who has previous experience in spinal surgery * Patient diagnosed with a serious liver or kidney disease * Patients with lymph fluid or blood clotting disorder or taking antithrombotic or antiplatelet agents * Patients with uncontrolled diabetes that may affect surgery or postoperative progress according to the investigator's judgment, * Patients with immunocompromised or autoimmune diseases such as rheumatoid arthritis or systemic erythematosus lupus, and severe systemic immune disease * Patients with infectious diseases or healing disorders that can interfere with the normal healing process after surgery * Patients who received steroid epidural injections within 2 weeks from the date of screening or who took oral steroids within 24 hours * Patients who participated in other clinical trials within 30 days from the date of screening * Patients who are unable to take MRI scans * Pregnant or lactating women * Patients who are not eligible for clinical trials according to the investigator's judgement * Patients with a history of hypersensitivity to the main and other components of the investigational device * Patients who are scheduled to receive myelogram or lumbar puncture within 24 hours from the application of the investigational device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI scar score | At 12 weeks after surgery | Primary effectiveness endpoint (0\~4, low Scar score through MRI means better) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index(ODI) score | Before surgery, At 2, 12 weeks after surgery | Secondary effectiveness endpoint (0\~50, low ODI score means better) |
| Visual Analog Scale(VAS) Back & Leg Pain Score | Before surgery, At 2, 12 weeks after surgery | Secondary effectiveness endpoint (0\~100, low VAS score means better) |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSiyoung Park
Yonsei University College of Medicine, Severance Hospital
Outcome results
None listed