Novel Nerve-Selective Treatment for Managing Knee Pain from Symptomatic Osteoarthritis: A Preliminary Case Series.

INTRODUCTION: Between conservative treatments and total knee arthroplasty, adequate interventional pain management options for osteoarthritis of the knee (OAK) are limited. BXT-786 is a novel nerve-selective biomaterial intended to provide prolonged analgesia when delivered around the nerve branches that innervate the knee joint for use in patients with symptomatic OAK. METHODS: We conducted a nonrandomized, single-cohort, open-label pilot feasibility study at a single site in Australia (ANZCTR.org ID: ACTRN12624000250538p) between April and December 2024. The primary objective of the current study was to evaluate the safety and tolerability of BXT-786 version 3.0 in four patients with symptomatic OAK. The secondary objective was to evaluate the preliminary analgesic performance of BXT-786 in managing knee pain associated with OAK. RESULTS: BXT-786 treatment showed a reduction in knee pain that was observed approximately 4 to 9 days post-procedure. Compared to the baseline, the subjects saw a 79.7% decrease in average numerical rating scale pain scores at 6 months. Anecdotal information indicated that most subjects experienced pain relief, which enabled increased mobility, improved use of the affected knee, and greater engagement in daily life activities. BXT-786 treatment did not affect motor functions or result in device-related serious adverse events. CONCLUSION: This study demonstrates feasibility of BXT-786 version 3.0 in four patients with symptomatic OAK. The observed preliminary clinical benefit of nerve-selective treatment also supports further investigation as a potential non-systemic, non-pharmacologic, and minimally invasive intervention option for long-term pain relief.