None listed
Conditions
Interventions
Medical Device : Experimental : Interblock
Comparator : Hibarry
Before the operation, the researcher opens the randomization envelope and checks whether the subject is receiving the test medical devi
s condition, site and extent of surgery, apply a maximum of 3-5 ml of test medical divice or contorl medical device.
Suture the sugical site.
Sponsors
Bioplus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female aged 20 and over 2) Diagnosed with disc herniation or lumbar stenosis through radiographic (MRI or CT) evidence of nerve root compression in L2-L6 lumbar spine or fifth lumbar spine 3) Have plan to be operated on decompression or percutaneous lumbar discectomy for the first time 4) Do not lose the pain associated with disc herniation or lumbar stenosis in nonsurgical treatment 5) Can understand and follow the instructions and participate in the clinical trial 6) Voluntary written consent to participate in the Clinical trial
Exclusion criteria
Exclusion criteria: 1) With a sensitive history of hyaluronic acid 2) Patients with degenerative spinal cord disease or scoliosis 3) Patients with lymphatic or blood coaulation disease or Patients receiving anticoagulants 4) Patients with diabetes that can not be controlled by researcher judgment 5) Received steroid treatment within 2 weeks of baseline or received oral steroid within 10 days 6) have collagen-vascular or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus) or have been treated for malignant tumors within 5 years 7) Received myelogram or lumbar puncture within 24 hours of baseline 8) Patients with impaired immunity or clinically significant abnormalities in clinical laboratory tests at screening 9) Patients who present clinically severe impairment in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or have a mental illness that significantly affects the trial 10) Participated in other clinical trials within 30 days from the screening date 11) Persons who are likely to become pregnant during the clinical trial and who do not consent to contraception in medically acceptable ways Medically acceptable methods of contraception: condoms, oral contraception for at least 3 months, use of contraceptives for injection or use, placement of intrauterine contraceptive devices, etc. 12) Pregnant or lactating women 13) In addition to the above, those who have clinical findings that the researcher judges to be inappropriate for the test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean value of MRI scar score assessed by independent evalutor at 6 weeks after medical device use for clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean value of 100-mm Visual Analogue Scale (VAS) for back pain assessed by the subject before and at 2 and 6 weeks after medical device use for clinical trial;Mean value of 100-mm Visual Analogue Scale (VAS) for leg pain assessed by the subject before and at 2 and 6 weeks after medical device use for clinical trial;Mean value of Oswestry Disability Index (ODI) for limitations of daily life assessed by the subject before and at 2 and 6 weeks after medical device use for clinical trial;Safety (Adverse event, Lab test, Physical examination) | — |
Countries
Korea, Republic of
Contacts
Public ContactJaeJun Yang
Dongguk University Ilsan Hospital
Outcome results
None listed