55 - Comparative Effectiveness of Cryoablation with Steroid and Lidocaine versus Steroid and Lidocaine Alone for Treatment of Morton Neuroma: Interim Analysis

Purpose: The objective of the study is to determine if image-guided cryoablation is superior to corticosteroid injection alone in short- and long-term outcomes for treatment of Morton neuromas that have failed conservative therapy. We are presenting our interim analysis results.

Materials and Methods: This is a nonblinded randomized controlled trial with patients randomized after meeting screening criteria and signing a consent in a 1:1 ratio based on the order of the presentation to steroid/lidocaine + cryoablation (treatment) or steroid/lidocaine alone (control) group. The primary outcome of the study is pain score measured by the visual analog scale (VAS). Secondary outcomes include quality of life and patients’ satisfaction with the treatment results. These were assessed by the neuroma scale, a modified American Orthopedic Foot and Ankle Society Hallux Metatarsophalangeal Interphalangeal scale score, quality of life survey, and clinic visit. Outcome assessment is performed at baseline visit, within 45 days before the procedure, and within 10 days, 1 month, 3 months, 6 months and 1 year. If a patient failed to improve after 3 months they are released from the trial and considered a treatment failure.

Results: This interim analysis includes 14 patients out of the anticipated 32; 7 treatment and 7 control. There were 10 female and 4 male patients with a median age of 58, ranging from 32 to 75. The mean change in baseline VAS at week 1 was -1.6 (SD 3.9) for the control and -1.8 (SD 2.2) in the cryoablation group. In the control group there was a decrease in pain score up until 1 month followed by a sharp increase in VAS at 3 months; at 3 months the VAS in the control group had increased by a mean change of 1.4 (SD 2.4). The cryoablation group continued to improve at 3 months with a mean VAS change of -2.0 (SD 1.4). Four patients in the treatment arm have been followed to 12 months and demonstrate a persistent improvement in VAS mean change of -2.25 with a range from unchanged to -6. Of note the patient with unchanged VAS was subsequently diagnosed with plantar fasciitis.

Two additional treatment arm patients have completed the 6-month follow-up with mean decrease in VAS of -4. Five of the control arm patients were released from the trial after 3 months due to treatment failure. None of the treatment arm patients were released early due to treatment failure.

Conclusion: Our interim analysis shows promising results that cryoablation with steroid/lidocaine injection provides more symptomatic and durable relief for patients with Morton’s neuroma when compared to steroid/lidocaine injection alone.