Improving the Safety of Transforaminal Epidural Steroid Injections in the Treatment of Cervical Radiculopathy

Background: Unplanned vascular trespass occurs in 20% of cervical transforaminal epiduralsteroid injections (CTFESI) and rarely results in devastating neurologic complications. The TrucathSpinal Injection System is a novel integrated catheter and needle device that is specificallydesigned to minimize vascular trespass risk.Objective: To compare the vascular trespass incidence with the Trucath Spinal Injection Systemversus standard spinal needles during CTFESI treatment in patients with cervical radiculopathy.Study Design: Prospective, multicenter, nonrandomized safety trial.Setting: Six tertiary spinal pain management centers in the United States.Methods: We treated 290 patients (411 levels) with recalcitrant cervical radiculopathy usingCTFESI; 129 patients (180 levels) were treated with the Trucath Spinal Injection System (Testgroup) and 161 patients (231 levels) were treated with standard spinal needles (Control group).All injections were administered via a transforaminal approach. Each site attained IRB approvalfor this study before any research was performed. The primary study endpoint was vasculartrespass per treated level. Secondary endpoints included nerve pain or paresthesia, injectionaccuracy, device performance measures, and procedural adverse events.Results: Vascular trespass occurred more often (odds ratio (OR): 3.1, 95% Confidence Interval(CI): 1.8-5.4, P < 0.001) in Controls (26.8%, 62/231 levels) versus Test patients (10.6%, 19/180levels). Radicular pain or paresthesia from device positioning was more frequent (OR: 21.1, 95%CI: 6.9-64.5, P < 0.001) in Controls (26.4%, 61/231) versus Test participants (1.7%, 3/179).Inadequate epiradicular flow was observed in 3.0% (7/231) of Controls and 5.6% (10/179) ofTest participants (OR: 0.5, 95% CI: 0.2-1.4, P = 0.22). Based on subjective physician judgment(scale: 1-10), there were no differences between the Test and Control groups, respectively, forease of use (mean 8.9 vs. 9.0), visualization under fluoroscopy (mean 9.2 vs. 9.0), and overallperformance (mean 9.0 vs. 8.6). No additional adverse effects were reported in either treatmentgroup in this clinical study.Limitations: The study did not randomly allocate the type of injection procedure to participantsand no clinical outcomes beyond the initial treatment were collected.Conclusions: The Trucath Spinal Injection System demonstrated a statistically significantreduction in the rate of intravenous and intra-arterial trespass, procedural pain, and paresthesia,and has similar accuracy and performance versus standard spinal needles for CTFESI treatmentof cervical radiculopathy.Key words: cervical, epidural, radiculopathy, steroid, transforaminal, Trucath, vascular trespass