SPR® Therapeutics Announces Publication of Study Providing Evidence of the Impact of SPRINT® PNS Treatment in Relieving Postoperative Knee Pain
2024年5月14日 - 3:16AM
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: Randomized
Placebo-Controlled Trial of 60-Day Percutaneous Peripheral Nerve
Stimulation Treatment Indicates Relief of Persistent Postoperative
Pain, and Improved Function After Knee Replacement
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.”
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.
SPR Contacts:Michelle McDonaldVice President –
Marketingmmcdonald@sprtherapeutics.com 844.378.9108
Dave FolkensPublic Relations dfolkens@sprtherapeutics.com
612.978.6547