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Univ. Lab Develops, Licenses Sports Injury Implant

Pitcher Matt Grace

Former Washington Nationals pitcher Matt Grace in a July 2019 game (A. Kotok)

1 Apr. 2021. A medical device company now offers a synthetic tissue implant for torn rotator cuff, a common sports injury, designed at a Purdue University engineering lab. Sparta Biopharma Inc. in Madison, New Jersey, licenses the technology behind the implant, based on research in Purdue’s Human Injury Research and Regenerative Technologies or HIRTT lab led by mechanical engineering professor Eric Nauman.

The rotator cuff is a set of muscles and tendons surrounding the shoulder joint that keeps the upper arm bone firmly in the shoulder joint socket. Injuries to the rotator cuff are common, particularly among older individuals and athletes in sports that put stress on arms and shoulders. A study by Nauman and colleagues published in 2013 cites data showing some 17 million Americans live with some kind of rotator cuff tendon tear, leading to more than 1 million surgical procedures per year to repair those injuries.

For high-performance athletes, a rotator cuff tear often means surgery, followed by a lengthy recovery and rehab period with no guarantee the joint will perform as well as before. A review of studies in 2016 investigating rotator cuff tears and the ability of athletes to return to their sports after surgery shows only half (50%) of professional and competitive athletes say they play as well after surgery as before. Baseball players are the athletes most treated for rotator cuff tears.

Nauman’s HIRTT lab studies new treatment methods for orthopedic injuries, such as sports injuries and gunshot wounds, as well as spinal cord and brain trauma, among others. Research by Nauman and then doctoral candidate Darryl Dickerson designed an implant to assist the enthesis, a key piece of connective tissue that joins rotator cuff tendons to the shoulder socket bone.

Heals and integrates with original tissue

“The enthesis is an important part of the skeleton,” says Nauman in a university statement, “because it makes it possible to transmit the enormous forces generated by the muscles during daily activities. Every muscle in a person’s body attaches from tendon to bone through an enthesis.”

The synthetic enthesis, about the size of a strip of gum, is made of mainly soft porous bone tissue with a thin layer of mineralized bone that attaches to the socket. The porous tissue in the enthesis implant acts as a matrix that encourages regeneration of torn tendons, with the mineralized bone layer simulating the natural bone-tendon connection. In their 2013 proof-of-concept study, Dickerson and Nauman successfully implanted the device in sheep that healed rotator cuff tears and integrated with the animals’ natural tissue. Purdue University filed patents on the technology, with Nauman and Dickerson listed as inventors.

Sparta Biopharma began collaborating with Purdue in 2018 to further develop the enthesis implant, which led to its first surgical use earlier this year. The device known as BioEnthesis encourages healing of tendons and bone, says Sparta, and integrates regenerated with original tissue, particularly where hard and soft tissue meet, which before had not been fully implemented. Rush University Medical Center in Chicago performed the first surgeries with the BioEnthesis in February 2021, and the company announced its commercial availability last month.

The inventors believe the technology can be used elsewhere in the body. Dickerson, now an engineering professor at Florida International University notes, “The success of BioEnthesis for this very challenging orthopedic repair offers insight that will enable future clinical breakthroughs.”

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