Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison with Guardix-SP Plus After Spine Surgery
- Conditions
- Herniation, Disc
- Interventions
- Device: Guardix-SP PlusDevice: MegaShield®-SP
- Registration Number
- NCT06369233
- Lead Sponsor
- L&C Bio
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Guardix-SP Plus Guardix-SP Plus The study group is applied with Guardix-SP after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 week to conduct examinations and assess Questionnaires. MegaShield®-SP MegaShield®-SP The study group is applied with MegaShield®-SP after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 week to conduct examinations and assess Questionnaires.
- Primary Outcome Measures
Name Time Method MRI scar score At 12 weeks after surgery Primary effectiveness endpoint (0\~4, low Scar score through MRI means better)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (4)
Eunpyeong ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Bundang Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of