Research Study - The Discseel Procedure
Authors: Kevin Pauza, MD , Kwadwo Boachie-Adjei, BS , Patrick Ercole, PhD , Francis Hussey, IV, MS , Joseph Nguyen, MPH , Akua Serwaa-Sarfo, MPH , Jacob Sutton, MD , Carrie Wright, MD, MS , William Delany Murrell, MD, MS
MANUSCRIPT NUMBER:
PAINPHYSICIAN-D-23-00261R1
FULL TITLE:
Long-term Investigation of Annulargrams, Intra-annular Fibrin Treat Chronic Discogenic LBP-Radiculopathy: 1-3 Year Outcomes Comparisons Patients with and without Prior Surgery
KEYWORDS:
low back, radiculopathy, fibrin, disc herniation, degenerative disc, regenerative, annulargram, annulogram
CORRESPONDING AUTHOR’S INSTITUTION:
Infohealth LLC
BACKGROUND:
Discogenic chronic low back pain (cLBP) and radiculopathy are most prevalent causes of disability worldwide. Prior spine treatments often lack reliability and are associated with adverse events. Among surgical treatment options, discectomies weaken discs to cause accelerated degeneration, and fusions directly cause damaging forces against adjacent discs accelerating their degeneration. Other regenerative
medicine treatments including “stem cell” centrifuged bone marrow aspirate (BMC),and Platelet-Rich Plasma (PRP), lack fibrin’s bio-adhesive properties. Specifically, fibrin is a strong bio-adhesive and it immediately integrates into disc defects and binds,
becomes part of the disc to facilitate new disc tissue growth.
OBJECTIVES:
Evaluate the safety and efficacy of this new pragmatic algorithm which both diagnoses and treats chronic low back pain by (i) identifying Annulus Fibrosus tears (fissures) region of symptoms, and (ii) treating those tears with fibrin, sealing them and facilitating new tissue growth.
STUDY DESIGN:
Retrospective cohort study that prospectively reported validated Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation measures in a registry.
SETTING:
Private, single center, specialized, interventional pain management institution
METHODS:
Subjects suffer with cLBP with or without radiculopathy for greater than six months. Prior to enrollment, all subjects underwent physical therapy and at least four invasive treatments without relief. Failed treatments included BMC or PRP injections, intradiscal or intra-articular into zygapophyseal joints, or combinations of both.
Additional failed treatments included fluoroscopically guided epidural corticosteroids or PRP, or Medial Branch radiofrequency neurotomies. Diagnostic certainty of underlying condition was confirmed by screening MRIs (1.5T) and plain-film radiographs
performed six months prior to treatment and confirmed in 100% of patients enrolled, without concomitant conditions: (i) carcinoma, (ii) fracture, (iii) instability, or (iv) severe vertebral canal or intervertebral foramen stenosis.
OUTCOMES ASSESSMENT:
Oswestry Disability Index (ODI), Low Back and Leg Pain Visual Analog Scale (VAS), PROMIS Global Mental Health (GMH), Estimated Utility Score (EuroQol), and Modified North American Spine Society (NASS) Patient Satisfaction Survey.
RESULTS:
Significant Improvement was demonstrated at 1-, 2-, and 3-years post treatment in all outcomes measures. Mean duration of low back pain prior to treatment was 11.2 years. Subject mean age 56 years, 30% female, 70% male. Both the failed surgery cohort and non-surgery cohort demonstrated significant improvement after fibrin treatment, with the failed surgery cohort realizing greater relative improvement. Significant Improvements in ODI, VAS, and PROMIS (Mental and Physical) were consistent across age, gender, co-morbidity and exposure status. At 12-month follow up, 50% of subjects achieved MCID utilizing ODI. No severe adverse events were reported.
LIMITATIONS:
Limitations include patient demographic factors, outcome-measure sensitivity, or that outcomes were reported prospectively and calculated retrospectively as 1-, 2-, and 3-year timeframes were attained. Although categorical analyses comparing prior surgical with non-surgical cohort was performed, pre-enrollment treatments were not categorized for comparison.
CONCLUSIONS:
Intra-annular fibrin bio-adhesive sealant demonstrates ability as an effective treatment to alleviate discogenic cLBP and radiculopathy for at least three years, even in subjects who all failed multiple prior treatments, including discectomy, fusion, disc PRP or BMC. Results suggest benefit of fibrin sealant; however, future investigations to consider include a randomized double-blind controlled trial and further categorical analyses.