Epidural Fibrosis, Lumbar Disc Herniation, Lumbar Spinal Stenosis, Postoperative Adhesion
Conditions
Brief summary
This multicenter, randomized, subject- and evaluator-blinded, active-controlled, non-inferiority clinical trial was conducted to evaluate the efficacy and safety of Collabarrier®, a collagen-based adhesion barrier, compared to Guardix-sol in patients undergoing lumbar spine surgery for herniated disc or spinal stenosis. A total of 69 adult patients scheduled for first-time partial laminectomy or discectomy were enrolled and randomly assigned to receive either Collabarrier® or Guardix-sol. The investigational device (Collabarrier®) is a gel-type atelocollagen formulation designed to prevent postoperative adhesions by acting as a physical barrier between the dura mater and surrounding tissues. The primary outcome was the mean MRI Scar Score at 6 weeks postoperatively, assessed by independent evaluators blinded to treatment allocation. Secondary outcomes included patient-reported pain scores using a 100-mm Visual Analog Scale (VAS) for low back and leg pain, and functional limitation assessed using the Oswestry Disability Index (ODI), measured at baseline, 3 weeks, and 6 weeks.
Interventions
DEVICECollagen-based adhesion barrier
Porcine Atelocollagen (Type I)
DEVICESodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier
Sodium Hyaluronate(HA) + Sodium Carboxymethylcellulose(CMC)
Sponsors
DALIM TISSEN Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants aged 19 years or older * Patients diagnosed with lumbar disc herniation or lumbar spinal stenosis based on radiological evidence (MRI or CT) showing nerve root compression at one of the following single levels: L3-L4, L4-L5, or L5-S1 * Patients scheduled to undergo their first partial laminectomy or discectomy for the above condition * Patients who meet at least one of the following criteria (A, B, C): * A. Have undergone a minimum of 4 weeks of prior conservative treatment within the 6 months prior to Visit 1 (e.g., physical therapy, use of anti-inflammatory drugs, or muscle relaxants) * B. Experience intolerable pain and are judged by the investigator to require surgery for lumbar disc herniation or spinal stenosis * C. Have significant progression of neurological functional loss * Patients who voluntarily provide written informed consent and are able to comply with the study procedures and visit schedule
Exclusion criteria
* Patients who shows alergic reaction or has previous stroke to main and other ingredients or components of the medical device for this clinical test * Patients with a medical history of brittle bone * Patients with a medical history of fracture in lumbar region or ligament injuries by external injury * Patients who needs to undergo a spine surgery (osteotomy allowable) in addition to partial laminectomy or percutaneous lumbar discectomy for cure of symptom * Patients with neurological function disorder on intestine/bladder * Patients with any of such symptoms as excessive exudation, bleeding, acute edema and infection on the part applied * Patients with Degenerative spinal disorder (other than disc herniation or spinal stenosis) or scoliosis (Cobb's angle is 15° or bigger) * Patients with any of lymphatic disease, coagulation disoder and/or coagulant taken * Patients with uncontrolled diabetes that may affect the surgery or the progress after surgery based on the tester's judgment * Patients with desmosis or autoimmune disease or who has ever taken malignant tumor treatment within 5 years before this surgery * Patients who has ever undergone a spine surgery on the part for this surgery * Patients who has ever taken extradural steroid treatment within 2 weeks before surgery or oral steroid drug within 10 days before surgery * Patients who has ever taken myelogram or lumbar puncture within 24 hours before screening * 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 * 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 * Participated in other clinical trials within 30 days from the screening * A pregnant woman or lactating woman * 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 * Patients determined by the researcher to be non-conformable to this clinical trials.
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 | 6 weeks after medical device application |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Baseline, 3 weeks, and 6 weeks after medical device application |
| 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 | Baseline, 3 weeks, and 6 weeks after medical device application |
| 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 | Baseline, 3 weeks, and 6 weeks after medical device application |
Countries
South Korea
Outcome results
None listed