CompletedNot Applicable

Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier®) in Spine Surgery

South Korea69 participantsStarted 2022-12-15

Plain-language 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.

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 disord…

What they're measuring

Mean value of MRI scar score assessed by independent evalutor at 6 weeks after medical device use for clinical trial

Timeframe: 6 weeks after medical device application

Trial details

NCT IDNCT07153822

SponsorDALIM TISSEN Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-29