NCT03909516

Evaluate the Iovera° Device in Treating Pain Associated With Anterior Cruciate Ligament Reconstruction

A Post-Market, Prospective Study to Evaluate the Iovera° Device in Treating Pain Associated With Anterior Cruciate Ligament Reconstruction

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the outcomes of patients undergoing iovera° treatment of the ISN, AFCN and LFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction

Detailed description

The most commonly reconstructed ligament in the knee is the anterior cruciate ligament (ACL). 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 basis. While this has led to improvements in patient satisfaction and cost, 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 ambulation. 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 error. 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 effects. 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 reconstruction. 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. 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

Conditions

• ACL Reconstruction

Interventions

Type	Name	Description
DEVICE	iovera°	The iovera° device will be prepared by the trained Anesthesiologist User Guide. If at any time the device does not perform as expected the Investigator and Anesthesiologist will follow procedures as outlined in the User Guide. Start and end time will be recorded. Once localized anesthesia of the block area is achieved, the Anesthesiolgist, or designee, will complete the iovera° treatment. Upon completion of block, The Anesthesiologist or designee will assess the treatment areas for adverse events. Adductor Canal Block required, the formulation, or "cocktail," of medications used are to be recorded in the medical record. Start and end time will be recorded. Local Infiltration Analgesia - 20cc 0.5% ropivicaine only

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2019-04-10
• Last updated: 2019-05-10

Regulatory

• FDA-regulated device study