Relief Resulted in Improved Objective Measure of Walking Ability at End of Treatment
Cleveland, Ohio – May 13, 2024 – SPR Therapeutics announced the publication of a multicenter double-blind randomized, placebo-controlled trial of individuals experiencing moderate-to-severe postoperative pain following knee replacement and treatment with the SPRINT PNS System. The study, published in the journal Neuromodulation, highlights the results from the prospective trial evaluating the impact of 60-day peripheral nerve stimulation (PNS) used for chronic knee pain after total knee arthroplasty (TKA). The primary efficacy endpoint was participants experiencing ≥50 percent pain relief during the last four weeks of treatment relative to baseline, and outcomes in the treatment and placebo groups were then compared. Additionally, the trial featured an objective measurement of performance through a six-minute walk test comparing end of treatment performance against a pre-treatment baseline walking ability. This outcome provides an added measure of impact and adds to the strength of the study design.
Read the full publication here.
Key outcomes included statistically significant results in both pain relief and the objective six minute walk test:
• Participants in the PNS treatment group experienced greater pain relief than those in the placebo group at the end of treatment. The majority of participants in the treatment group (60 percent, n=12/20) were responders and met the primary endpoint (≥50 percent pain relief during final four weeks of treatment compared to baseline) versus a minority of those in the placebo group (24 percent, n=5/21; p=0.028).
• The average pain relief within the PNS group (n=20) was 54 percent, which was greater than in the placebo group (26 percent, n=21; p=0.0021).
• Participants in the trial conducted a six-minute walk test prior to the start of treatment and after completion of treatment (n=18) or placebo (n=20). The mean improvement in walking ability at the end of treatment for the PNS group was an increase of 47 percent while the placebo group saw a decline of nine percent in its performance (p=0.0484). This objective measure highlights important, measurable improvement in function for study participants.
No study-related adverse events (AE) were serious or unanticipated. Dermatological AEs (e.g., skin irritation due to bandaging) made up most events (37 of 41; 10 events in the PNS group and 27 events in the placebo group).
TKA is an effective approach to treating a range of significant knee conditions and is expected to grow from an estimated 800,000 annually today to between 1.2 – 3.4 million procedures per year by 2040. Despite the success and adoption of TKA, between 10-20 percent of patients experience persistent postoperative pain more than three months after surgery. This continued
pain creates added burdens for patients in their recovery, efforts to get back to work, and meaningful impact on the supportive care needed from caregivers and the healthcare system. Patients with ongoing postoperative pain experience a reported 40-57 percent increase in healthcare costs when compared to those that were satisfied with their outcomes.
“We saw clear pain reduction in patients’ chronic post-replacement knee pain receiving PNS therapy, our primary focus. Seeing the additional impact on walking ability and quality of life measures in this trial was also remarkable, as those improvements reflect a meaningful, day-to day impact of the PNS therapy,” said Dr. David Dickerson, author, Section Chief for Pain Medicine, Endeavor Health Medical Group and SPR Consultant. “The marked differences in objective measure like the six-minute walking test in a sham-controlled study further defines real benefit for patients treated with PNS.”
“Lingering pain following TKA is, unfortunately, a significant unmet need. This study, which also measured quality of life and is one of the only in PNS to include an objective measurement of function, illustrates the impact of SPRINT PNS in improving patient experience and recovery. While cost effectiveness was not evaluated, these impactful results could have potential healthcare system savings,” said Maria Bennett, President, CEO and Founder of SPR Therapeutics. “We are very encouraged by these study results and the opportunity for SPRINT PNS to fill an unmet need allowing patients to return to their lives following TKA.”
This work was supported by The Office of the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Orthopaedic Research Program under Award No. W81XWH1810799. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
About the SPRINT PNS System
The SPRINT® PNS System, by SPR® Therapeutics, marks an innovative shift in the treatment of pain. Our breakthrough, 60-day treatment is a First-Line PNS™ option uniquely proposed to recondition the central nervous system to provide significant and sustained relief from chronic pain — without a permanent implant, nerve destruction or the risk of addiction. The system has been studied extensively for low back pain, knee pain, shoulder pain, post-amputation pain, and chronic and acute postoperative pain, is cleared for use up to 60 days, and is recognized by leading pain management centers. Market research indicates that this breakthrough neuromodulation treatment is a patient-preferred alternative to more invasive options.
The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; symptomatic relief of post traumatic pain; symptomatic relief of postoperative pain. The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
Physicians should use their best judgment when deciding when to use the SPRINT PNS System. For more information see the SPRINT PNS System IFU. Most common adverse events are skin irritation and erythema. Results may vary. Rx only.
For additional information regarding safety and efficacy, visit: SPR Safety Information.
About SPR Therapeutics, Inc.
SPR Therapeutics is a privately held medical device company, providing patients with a non opioid, minimally invasive pain treatment option. Our SPRINT® PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain. Backed by the largest body of clinical evidence in peripheral nerve stimulation for the treatment of pain, SPR has demonstrated commercial demand in untapped peripheral (shoulder and knee) and back pain markets and built an incredibly strong foundation for commercial growth. Headquartered in Cleveland, OH with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s Senior Management team includes experienced industry veterans with nearly 200 years of collective pain market and MedTech expertise, all driven by our purpose – to improve the quality of patients’ lives by providing them with a minimally-invasive, drug-free, surgery-free solution to manage their acute and chronic pain.
More information can be found at www.SPRTherapeutics.com.
