None listed
Conditions
Interventions
None listed
Sponsors
MEDIJ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between the ages of 20 and 80 2) Persons diagnosed with disc herniation or lumbar stenosis through radiographic evidence (MRI or CT) for nerve root compression at the 4th, 5th lumbar or 5th lumbar spine 3) Among patients with the above diagnosis, those who are planning to perform spinal surgery such as nerve decompression or discectomy for the treatment of the above symptoms for the first time 4) Those who require spinal surgery because they do not have the therapeutic effect of related pain or paralysis through non-surgical treatments include disc herniation or lumbar stenosis 5) Those who understand and follow the instructions and who can participate during whole period throughout the clinical trial 6) Those who voluntarily decide to participate in this clinical trial and agree by writing on consent for clinical subjects.
Exclusion criteria
Exclusion criteria: 1) Those who are sensitive to hyaluronic acid, collagen, sodium carboxymethylcellulose 2) Patients with degenerative spinal cord disease (myelopathy) or scoliosis 3) Patients with lymphatic or blood clotting disorders, or who are administering blood coagulants 4) Those with uncontrolled diabetes that may affect surgery or postoperative progress at the judgment of the examiner 5) Those who received dural steroid treatment within 2 weeks from baseline or oral steroid within 10 days 6) Those who have collagen-vascular disease or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus) or who have received treatment for malignant tumors within 5 years 7) Those who have received a myelogram or lumbar puncture within 24 hours from the baseline 8) Those with reduced immunity or who have clinically significant abnormalities in hematological, hematological, and urine tests, which are laboratory tests performed at the time of screening 9) Those who have clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or who have had or currently have mental disorders that significantly affect this clinical trial (e.g., cardiopulmonary disease, infectious disease , Coagulation and bleeding disorders, myocardial infarction, congestive heart failure, kidney failure, mental illness, epilepsy, schizophrenia, lack of cognitive ability, etc.). 10) Those who participated in clinical trials of other drugs or medical devices within one month prior to enrollment in this clinical trial 11) Those who do not agree to use a medically acceptable method of contraception* among female subjects who may be pregnant during the clinical trial period * Medically acceptable method of contraception: condom, oral contraception lasting for at least 3 months, week In the case of using contraceptives for use or insertion, installation of an intrauterine contraceptive device, etc. 12) Pregnant or nursing women 13) In addition to the above criteria, those who has clinically significant findings that are considered inappropriate for this test by the person in charge of the study or in person in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average of the MRI Scar Score total score of the test group and the control group evaluated by independent evaluators | — |
Secondary
| Measure | Time frame |
|---|---|
| The average value of the Visual Analogue Scale (VAS) for back pain in the test and control groups;The average value of the Visual Analogue Scale (VAS) for leg pain in the test and control groups;The average value of the Oswestry Disability Index (ODI) on the daily life limitations of the test and control groups | — |
Countries
Korea, Republic of
Contacts
Public ContactChul Ju Hwang
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed