title: Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up.
abstract: OBJECTIVE
  Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain.
  
  
  METHODS
  Prospective, nonrandomized Food and Drug Administration approved pilot study.
  
  
  METHODS
  Three centers in the United States.
  
  
  METHODS
  Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography.
  
  
  METHODS
  Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX(®) Fibrin Sealant with the Biostat(®) Delivery Device into symptomatic lumbar disc(s).
  
  
  METHODS
  Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ).
  
  
  RESULTS
  Safety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product.
  
  
  RESULTS
  Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6-80.3) at baseline to 31.7 (17.4-46.1), 35.4 (17.7-53.1), and 33.0 (16.3-49.6); mean RMDQ score improved from 15.2 (12.7-17.7) at baseline to 8.9 (5.3-12.5), 6.2 (3.4-9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively.
  
  
  CONCLUSIONS
  Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain.
authors.affiliation: Bellingham Spine Pain Specialists, Bellingham, Washington, USA.
authors.forename: Way
authors.initials: W
authors.lastname: Yin
authors.forename: Kevin
authors.initials: K
authors.lastname: Pauza
authors.forename: Wayne J
authors.initials: WJ
authors.lastname: Olan
authors.forename: Jeff F
authors.initials: JF
authors.lastname: Doerzbacher
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Thorne
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004185:Disability Evaluation; D015299:Discitis / Q000139:chemically induced; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D007405:Intervertebral Disc Displacement / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D017116:Low Back Pain / Q000000981:diagnostic imaging / Q000209:etiology* / Q000473:pathology; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D011446:Prospective Studies; D011859:Radiography; D013035:Spasm / Q000139:chemically induced; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D015718:Fibrin Tissue Adhesive
keywords: Discogenic Pain; Fibrin Sealant; Injection; Intervertebral Disc; Low Back Pain