SIR 2024
Pain Management/MSK
Jacob W. Fleming, MD
Fellow, Musculoskeletal IR
Clinical Radiology of Oklahoma
Financial relationships: Full list of relationships is listed on the CME information page.
Douglas Beall, MD, FSIR
Chief of Radiology Services
Comprehensive Specialty Care
Financial relationships: Full list of relationships is listed on the CME information page.
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 were enrolled. All patients had CLBP due to DDD confirmed by imaging and discography and received injections of hydrogel at either 1 or 2 lumbar disc levels (total of 31 levels treated) from August 2020 to May 2020. The primary safety endpoint is freedom from Serious Adverse Events (SAEs), and the primary performance endpoint is successful gel delivery into the desired disc. Patients were assessed on the NRS as well as the Oswestry Disability Index (ODI) at baseline, 1 month, 3 months, 6 months, 1 year and 2 year time points. Radiographs, CTs and MRIs were taken pre and postprocedure. Adverse events and medication were recorded.
Acknowledgement is made to ReGelTec, Inc for support and funding of the study.
Results:
Sixteen patients were followed up at a mean of 686 days and four patients were lost to follow up. Preliminary results show significant reductions in back pain NRS from 7.2 to 1.9 (74% reduction) and ODI scores from 54 to 12 at 24 months follow up (78% improvement) (Figures 1 and 2). Patient satisfaction at 24 months was 100% was either satisfied (26.7%) or very satisfied (73.3%) with the implant. When asked if they would recommend the device to a friend or family member 93.3% of the patients said “Yes” (Figures 3 and 4).
Conclusion:
The data collected on 20 subjects receiving the HYDRAFIL implant through the EFS have demonstrated a low incidence rate of serious adverse events. Clinical results showed significant improvement in mean NRS and ODI at the initial post-operative visit and was sustained through two years. Improved clinical outcomes are also seen in the six (6) subjects requiring partial device removal. The hydrogel was successfully injected into all of the targeted intervertebral discs. This early feasibility study indicates the possibility that hydrogel may be effectively used to treat painful DDD and CLBP.