Campbell Clinic in Memphis, Tenn, has begun enrolling patients in a clinical trial studying how well the iovera° system helps manage pain among postsurgical knee patients without the use of opioids.
A total of 120 patients will be enrolled in the trial, which will study the effects of the iovera° technology, a non-opioid and non-systemic treatment designed to use the body’s natural response to cold to help block pain signals from peripheral nerves.
The effect on the nerve is transient, providing pain relief until the nerve regenerates and its sensory function is fully restored, according to Myoscience Inc, its manufacturer, in a media release.
Patients in the trial will be randomized 1:1. Those in the study arm will receive iovera° therapy in the index knee 3 to 7 days before total knee arthroplasty, while patients in the control arm will receive current standard of care (without the iovera° therapy).
“I am very excited to begin enrolling patients in the iovera° study looking at reducing pain and narcotic use after total knee replacement,” says Dr William M. Mihalko, MD, the study’s principal investigator, in the release.
“We hope the iovera° technology will help us meet one of the significant needs today—reducing the reliance on opioid-based pain medication after total knee replacement surgery,” he adds.
Patients from six orthopedic surgeons’ practices at the Campbell Clinic will participate in this trial, the goal of which will be to show that the iovera° therapy can help reduce opioid consumption after total knee replacement independent of surgical practice.
Cary G. Vance, president and CEO of Silicon Valley, Calif-based Myoscience, states, “I am very excited to see that we are able to conduct this study at a renowned institution like the Campbell Clinic. Data from this study will demonstrate and confirm that the iovera° technology can be a solution to help address the opioid epidemic in our nation today.”
[Source(s): Myoscience Inc, PRWeb]