A clinical study of the safety and effectiveness of ionized atelocollagen based adhesion barrier(Collabarrier®) for adhesion prevention in spine surgery
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0007858
- Lead Sponsor
- Dalim Tissen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
1) Male and female adults over the age of 19
2) Patients who has been diagnosed with disc herniation or spinal stenosis through a radiological (MRI or CT) proof on nerve root compression on one level of L3-L4 or L4-L5 or L5-S1.
3) Patients who is supposed to undergo partial laminectomy or percutaneous lumbar discectomy to be cured of the symptoms specified above in the 2).
4) Patients relevant to any of following cases:
A. Patients who took prior conservative cure for at least 4 weeks for 6 months before V1(patients who took any of such therapies and drugs as physical therapy, anti-inflammatory drug, muscle relaxant and etc.)
B. Patients who suffers any unbearable pain and is determined by the relevant researcher to need to undergo a surgery for slipped disk or lumbar spinal stenosis
C. Patients with neurological function considerably lost
5) Voluntary consent in document form is needed; and the volunteer must be able to comply with the clinical test procedures and schedule.
1) Patients who shows alergic reaction or has previous stroke to main and other ingredients or components of the medical device for this clinical test
2) Patients with a medical history of brittle bone
3) Patients with a medical history of fracture in lumbar region or ligament injuries by external injury
4) Patients who needs to undergo a spine surgery (osteotomy allowable) in addition to partial laminectomy or percutaneous lumbar discectomy for cure of symptom
5) Patients with neurological function disorder on intestine/bladder
6) Patients with any of such symptoms as excessive exudation, bleeding, acute edema and infection on the part applied
7) Patients with Degenerative spinal disorder (other than disc herniation or spinal stenosis) or scoliosis (Cobb’s angle is 15° or bigger)
8) Patients with any of lymphatic disease, coagulation disoder and/or coagulant taken
9) Patients with uncontrolled diabetes that may affect the surgery or the progress after surgery based on the tester’s judgment
10) Patients with desmosis or autoimmune disease or who has ever taken malignant tumor treatment within 5 years before this surgery
11) Patients who has ever undergone a spine surgery on the part for this surgery
12) Patients who has ever taken extradural steroid treatment within 2 weeks before surgery or oral steroid drug within 10 days before surgery
13) Patients who has ever taken myelogram or lumbar puncture within 24 hours before screening
14) Patients with impaired immunity or clinically significant abnormalities in clinical laboratory tests at screening Patients with immunity deteriorated or who shows clinically significant abnormality in lab test items at the moment of screening
15) 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
16) Participated in other clinical trials within 30 days from the screening
17) A pregnant woman or lactating woman
18) Patients who cannot comply with any requirement of the document form consent for this clinical test from the signing date of signature on the consent till the final day of visit
19) Patients determined by the researcher to be non-conformable to this clinical trials.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean value of MRI scar score assessed by independent evalutor at 6 weeks after medical device use for clinical trial;All adverse events that occurred to the subjects
- Secondary Outcome Measures
Name Time Method Mean value of 100-mm Visual Analogue Scale (VAS) for back pain assessed by the subject before and at 3 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 3 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 3 and 6 weeks after medical device use for clinical trial