BACKGROUND: Unplanned vascular trespass occurs in 20% of cervical transforaminal epidural steroid injections (CTFESI) and rarely results in devastating neurologic complications. The Trucath Spinal Injection System is a novel integrated catheter and needle device that is specifically designed to minimize vascular trespass risk. OBJECTIVE: To compare the vascular trespass incidence with the Trucath Spinal Injection System versus 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 using CTFESI; 129 patients (180 levels) were treated with the Trucath Spinal Injection System (Test group) 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 approval for this study before any research was performed. The primary study endpoint was vascular trespass per treated level. Secondary endpoints included nerve pain or paresthesia, injection accuracy, 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%, 19/180 levels). 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) of Test 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, for ease of use (mean 8.9 vs. 9.0), visualization under fluoroscopy (mean 9.2 vs. 9.0), and overall performance (mean 9.0 vs. 8.6). No additional adverse effects were reported in either treatment group in this clinical study. LIMITATIONS: The study did not randomly allocate the type of injection procedure to participants and no clinical outcomes beyond the initial treatment were collected. CONCLUSIONS: The Trucath Spinal Injection System demonstrated a statistically significant reduction 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 treatment of cervical radiculopathy.
BACKGROUND: Unplanned vascular trespass occurs in 20% of cervical transforaminal epidural steroid injections (CTFESI) and rarely results in devastating neurologic complications. The Trucath Spinal Injection System is a novel integrated catheter and needle device that is specifically designed to minimize vascular trespass risk. OBJECTIVE: To compare the vascular trespass incidence with the Trucath Spinal Injection System versus 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 using CTFESI; 129 patients (180 levels) were treated with the Trucath Spinal Injection System (Test group) 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 approval for this study before any research was performed. The primary study endpoint was vascular trespass per treated level. Secondary endpoints included nerve pain or paresthesia, injection accuracy, 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%, 19/180 levels). 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) of Test 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, for ease of use (mean 8.9 vs. 9.0), visualization under fluoroscopy (mean 9.2 vs. 9.0), and overall performance (mean 9.0 vs. 8.6). No additional adverse effects were reported in either treatment group in this clinical study. LIMITATIONS: The study did not randomly allocate the type of injection procedure to participants and no clinical outcomes beyond the initial treatment were collected. CONCLUSIONS: The Trucath Spinal Injection System demonstrated a statistically significant reduction 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 treatment of cervical radiculopathy.