Treatment of Painful Lumbar Degenerative Disc Disease with Intradiscal Hydrogel: 24 Month Results of an Early Feasibility Study

Sunday, March 30, 2025

4:12 PM – 4:21 PM CT

Location: Music City Center, 207 AB

Presenting Author(s)

MS

Matthew C. Shonnard, MD, MPH

Fellow
Comprehensive Speciality Care, United States

Author/Co-author(s)

Douglas Beall, MD, FSIR

Chief of Radiology Services
Comprehensive Specialty Care, United States
Jacob W. Fleming, MD

Interventional Musculoskeletal Radiologist
Vascular and Interventional Specialists, United States
OB

Olivia Beall, MA

Consultant
Comprehensive Speciality Care, Clinical Radiology of Oklahoma, United States
TP

Tyler R. Phillips, M.D.

Fellow
Clinical Radiology of Oklahoma, United States
KA

Kasra Amirdelfan, MD

Medical Director
IPM Medical Group, United States
OC

Olivier Clerk-Lamalice, MD

Physician
Beam Radiology, Canada
PN

Pierce D. Nunley, M.D.

Director
Spine Institute of Louisiana, United States

Purpose:

Low back pain is the most common musculoskeletal problem worldwide, resulting in large medical and disability costs (1). Degenerative disc disease (DDD) represents the most common single cause of chronic low back pain (CLBP). This is a prospective single arm feasibility study that is a first-in-human trial to evaluate an injectable hydrogel (Hydrafil), and to assess its safety and performance.

Materials and Methods:

The hydrogel was injected through a 17-gauge needle under fluoroscopic guidance with patients under moderate sedation. 20 patients from 21 to 69 years of age with Numerical Rating Scale (NRS) pain ≥ 4 with CLBP due to DDD (confirmed by imaging and discography) received injections of hydrogel at either 1 or 2 lumbar disc levels (total of 31 levels treated) from August 2020 to May 2020. Primary safety endpoint was freedom from Serious Adverse Events (SAEs), and the primary performance endpoint was successful gel delivery into the desired disc. NRS and Oswestry Disability Index (ODI) at baseline, 1 month, 3 months, 6 months, 1 year, and 2 years. Radiographs, CTs and MRIs were taken pre- and post-procedure.

Results:

Hydrogel was successfully injected into all of the targeted intervertebral discs. At 24-month follow-up, significant reductions were seen in back pain NRS from 7.2 to 1.9 (74% reduction) and ODI scores from 54 to 12 (78% improvement). Patient satisfaction at 24 months was 100% (73.3% very satisfied, 26.7% satisfied).

Conclusion:

Clinical results showed significant improvement in mean NRS and ODI at the initial post-operative visit and sustained through two years. This early feasibility study indicates the possibility that hydrogel may be effectively used to treat painful DDD and CLBP.