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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MegaShield®-SP | Experimental | 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. |
|
| Guardix-SP Plus | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MegaShield®-SP | Device | MegaShield®-SP application Lumbar discectomy or laminectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MRI scar score | Primary effectiveness endpoint (0~4, low Scar score through MRI means better) | At 12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index(ODI) score | Secondary effectiveness endpoint (0~50, low ODI score means better) | Before surgery, At 2, 12 weeks after surgery |
| Visual Analog Scale(VAS) Back & Leg Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siyoung Park | Yonsei University College of Medicine, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang Seoul National University Hospital | Seongnam-si | 13620 | South Korea | |||
| Eunpyeong ST. Mary's Hospital |
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| Guardix-SP Plus |
| Device |
Guardix-SP Plus application Lumbar discectomy or laminectomy |
|
Secondary effectiveness endpoint (0~100, low VAS score means better)
| Before surgery, At 2, 12 weeks after surgery |
| Seoul |
| 03312 |
| South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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