SPR® Therapeutics Publishes Study on SPRINT® PNS for Postoperative Knee Pain Relief and Improved Walking Ability

CLEVELAND, May 14, 2024-- SPR Therapeutics has announced the publication of a significant study in the journal Neuromodulation. This multicenter, double-blind, randomized, placebo-controlled trial focused on individuals suffering from moderate-to-severe postoperative pain following knee replacement surgery, specifically examining the impact of the SPRINT Peripheral Nerve Stimulation (PNS) System.

The trial assessed the efficacy of a 60-day PNS treatment for chronic knee pain post-total knee arthroplasty (TKA). The primary endpoint of the study was the proportion of participants experiencing at least 50 percent pain relief during the last four weeks of treatment compared to their baseline pain levels. The results from the treatment and placebo groups were then compared to evaluate the effectiveness of the PNS system.

An additional objective measure of the study was the performance in a six-minute walk test, which compared participants' walking ability before and after the treatment period. This added a robust layer of evidence to the study design, highlighting the functional improvements in patients.

Key findings from the trial included statistically significant pain relief and improved performance in the six-minute walk test for the PNS treatment group. Specifically, 60 percent of participants in the PNS group (12 out of 20) met the primary endpoint of achieving at least 50 percent pain relief, compared to only 24 percent in the placebo group (5 out of 21). The average pain relief for the PNS group was 54 percent, markedly higher than the 26 percent observed in the placebo group. 

Regarding functional improvements, participants in the PNS group showed a mean increase of 47 percent in their walking ability by the end of the treatment period, while those in the placebo group experienced a 9 percent decline. This underscores the tangible benefits in mobility and daily functionality for those treated with PNS.

The study also reported that none of the adverse events related to the study were serious or unexpected. Most adverse events were minor dermatological issues, such as skin irritation from bandaging, with 10 events in the PNS group and 27 in the placebo group.

Given the increasing number of TKA procedures, which are projected to rise from 800,000 annually to between 1.2 and 3.4 million by 2040, managing postoperative pain remains a critical challenge. Persistent pain affects 10-20 percent of patients after TKA, leading to higher healthcare costs and extended recovery periods.

Dr. David Dickerson, one of the study's authors and Section Chief for Pain Medicine at Endeavor Health Medical Group, emphasized the importance of the findings. He noted the significant pain reduction and improvement in walking ability among patients undergoing PNS therapy, highlighting the real-world impact of the treatment on patients' daily lives.

Maria Bennett, President, CEO, and Founder of SPR Therapeutics, also expressed confidence in the study's results. She underscored the potential of SPRINT PNS to meet an unmet medical need by improving patient recovery and overall experience post-TKA, suggesting that these benefits could translate into healthcare system savings.

The SPRINT PNS System by SPR Therapeutics represents a novel approach to pain management. The system offers a 60-day treatment option designed to recondition the central nervous system, providing substantial and lasting pain relief without the need for permanent implants or the risk of addiction. This system has been extensively studied and is approved for various types of pain, including chronic, post-surgical, and post-traumatic pain.

SPR Therapeutics is committed to providing minimally invasive, non-opioid pain treatment options, addressing a critical need for millions suffering from chronic pain. The company is headquartered in Cleveland, OH, with additional offices in Chapel Hill, NC, and Minneapolis, MN.

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