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Two-Year Outcomes Following Treatment of Painful Lumbar Degenerative Disc Disease with a Percutaneous Polymer-Based
Olivier Clerk-Lamalice1,2, Alfonso Spath3, Kimberly Carcary1,2
1Beam Interventional & Diagnostic Imaging, Calgary, Alberta, Canada.
Study Design:
Prospective, single arm, multicenter, feasibility study.
Objective:
To determine implant and patient-reported outcomes of percutaneous implantation of an intervertebral disc augmentation hydrogel for treatment of chronic low back pain (CLBP) secondary to degenerative disc disease at 24 months follow-up.
Summary Of Background Data:
A feasibility study recently demonstrated a novel polymer- based hydrogel was safely and successfully implanted in 83 lumbar intervertebral discs in 60 patients with CLBP. Secondary patient-reported outcome measures indicated clinically significant improvements in function, low back pain, and lower limb pain within one month post-procedure through 12 months.
Methods:
Patients with CLBP >6 months duration, Modified Pfirrmann grades 4-8 disc degeneration, Numeric Rating Scale (NRS) ≥4, Oswestry Disability Index (ODI) ≥30, and a competent outer annulus were enrolled in three outpatient clinics. The single-use hydrogel implant was heated to 65°C and delivered intradiscally to the nucleus pulposus with a 17G cannula using fluoroscopic guidance, under local anesthesia. ODI and NRS were collected at 1, 3, 6, 12, and 24 months. The primary outcome was ODI and NRS scores at 24 months.
Results:
Sixty patients (36 female, mean age 49.0±9.3 y) received 83 implants. ODI scores improved from 57.5±1.5 (baseline) to 10.2±1.8 (24 mo, P <0.001). NRS Back Pain scores improved from 7.3±0.2 (baseline) to 1.6±0.3 (24 mo, P <0.001). NRS Lower Limb Pain scores improved from 5.5±0.4 (baseline) to 1.5±0.3 (24 mo, P <0.001). All mean improvements surpassed minimal clinically important differences.
Conclusion:
Patients reported that clinically meaningful improvements in function and reductions in pain observed at 1 and 12 months post-intervention were maintained through 24 months following percutaneous intradiscal implantation of a polymer-based hydrogel. These outcomes suggest a sustained positive outcome, but should be confirmed in a randomized controlled trial.
Level Of Evidence:
III, prospective cohort study.
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