FDA-Cleared Technique for Knee Repair Validated in OHSU Clinical Trial

Oregon Health & Science University
This week's FDA granting of marketing authorization of implantable shock absorber marks first new surgical treatment in decades for osteoarthritis of the knee

Karla Hunt stands atop a peak in Scotland in 2017, a few weeks after undergoing a surgical treatment for osteoarthritis in the knees at OHSU. Hunt underwent the procedure as part of a nationwide clinical trial validating a new implantable shock absorber for the knee known as MISHA. Now FDA-approved, OHSU expects to be able to offer the procedure routinely in the coming months. (Courtesy)

Karla Hunt stands atop a peak in Scotland in 2017, a few weeks after undergoing a surgical treatment for osteoarthritis in the knees at OHSU. Hunt underwent the procedure as part of a nationwide clinical trial validating a new implantable shock absorber for the knee known as MISHA. Now FDA-approved, OHSU expects to be able to offer the procedure routinely in the coming months. (Courtesy)

Oregon Health & Science University is among the clinical centers to validate a new treatment approach that could improve the lives of millions of people afflicted with osteoarthritis of the knee.

The Food and Drug Administration on Monday granted authorization to market a new implantable shock absorber to treat mild to moderate cases of osteoarthritis causing arthritic pain and loss of function in patients. Federal clearance of the MISHA knee system clears the way for widespread adoption of the first new surgical treatment for osteoarthritis of the knee in decades.

OHSU is among five centers involved in the nationwide clinical trial that validated the new approach, and expects to be able to offer the procedure routinely in the coming months.

Dennis Crawford M.D., Ph.D. (OHSU)

Dennis Crawford M.D., Ph.D. (OHSU)

"Quite frankly, there hasn't been a substantial development for the treatment of this ubiquitous disease for more than 50 years," said Dennis Crawford, M.D., Ph.D., professor of orthopaedics and rehabilitation in the OHSU School of Medicine.

Aside from total knee replacement — typically not recommended for people younger than 60 — Crawford said the usual treatment involves physical therapy, anti-inflammatory medicine and bracing to minimize pain from the condition, which is caused by protective cartilage wearing down over time. For many people, those treatments aren't enough to restore health and function.

"The MISHA surgical procedure is truly revolutionary and will provide treatment of some forms of osteoarthritis sooner," Crawford said. "This is not only good for the knee, but good for one's health and capacity for activity."

'It changed my life'

Karla Hunt can testify to that.

As a nursing home administrator, Hunt was normally on her feet for most of the day at work and went backpacking in Northwest forests and mountains during her time off. However, when she injured her knee in 2016, her orthopedist advised her to minimize her activity.

"They were recommending that I just give up all the things that I loved," said Hunt, 57 at the time.

Searching for alternatives, she came across a new clinical trial at OHSU and reached out to Crawford. She enrolled in the trial and Crawford implanted the MISHA device on March 24, 2017, in an outpatient procedure at OHSU. Hunt lives in Hubbard, a small Willamette Valley town south of Portland.

After eight weeks of recovery, she resumed the active lifestyle she had enjoyed throughout her life.

Now 63, Hunt said the implant made an immediate difference.

"It changed my life," she said. "It allows me to do things I never would have been able to do otherwise."

Recovery took about two months. Soon after that, she relished the opportunity to resume a fully active lifestyle — starting with a trip overseas.

"I went to Scotland for vacation," she said. "I climbed mountains and hiked, and did all the activities I love to do — and I've been able to do ever since."

Moximed provided research support for the clinical trials involved with the MISHA Knee System.

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