Anterior Cruciate Ligament Reconstruction Clinical Trial
Official title:
A Post-Market, Prospective Study to Evaluate the Iovera° Device in Treating Pain Associated With Anterior Cruciate Ligament Reconstruction and Rehabilitation
To evaluate the outcomes of patients undergoing iovera° treatment of the ISN and AFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction
The most commonly reconstructed ligament in the knee is the anterior cruciate ligament
(ACL)1. In 2006 a total of 134,421 ACL reconstructions were performed in the United States,
representing a 37% increase in procedures since 19941. Today, most ACL reconstructions are
performed on an outpatient basis2. While this has led to improvements in patient
satisfaction3 and cost4, it has simultaneously resulted in more complicated postoperative
pain management. Managing this pain via multi-modal strategies, including peripheral nerve
blocks, in the postoperative phase has been shown to decrease opioid related side effects,
decrease hospital stay, and increase time to ambulation5. Nursing, hospital, and pharmacy
utilization in managing PCA, continuous regional nerve blocks, and administration of oral
opioid dosing are associated with higher costs of care and introduce sources for staff
error6,7. Furthermore, the idea of multi-modal pain management extends beyond the surgical
procedure. Decreasing prescription opioid use during outpatient rehabilitation decreases
NSAID and opioid related side effects8.
Myoscience, Inc. (Fremont, CA) has developed a device - iovera° - as a novel,
minimally-invasive procedure using cold to target sensory nerve tissue and provide temporary
pain relief through cryoneurolysis. The iovera° device uses well-established principles of
cryobiology to temporarily deactivate sensory nerves that contribute to pain. Prior studies
of the iovera° device have provided evidence of effectiveness and safety for treatment of the
Infrapatellar Branch of the Saphenous Nerve and another study has demonstrated that a
short-term block of this nerve resulted in reduced pain following an ACL repair.9
In a multicenter, double-blind, sham-controlled, randomized trial sponsored by Myoscience,
Inc, the iovera° device was shown to temporarily relieve pain in patients with osteoarthritis
of the knee. Compared to the sham group, patients who received active treatment had a
statistically significant greater change from baseline in the WOMAC pain subscale score at
Day 30 (p=0.0004), Day 60 (p=0.0176), and Day 90 (p=0.0061). Patients deemed WOMAC pain
responders at Day 120 continued to experience a statistically significant treatment effect at
Day 150. Most expected side effects were mild in severity and resolved within 30 days. The
incidence of device- or procedure-related adverse events was similar in the two treatment
groups with no occurrence of serious or unanticipated adverse events.10
The goal of the study described herein is to determine the safety and efficacy of the iovera°
treatment for reducing the pain associated with anterior cruciate ligament (ACL)
reconstruction and rehabilitation.
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