It is not unusual for medical residents to be involved in clinical trials. What is unusual is for residents to be running clinical trials on medical devices that they invented.
But that is exactly where Sandeep Mannava, in his seventh year of residency in the orthopaedic surgery department at Wake Forest Baptist Medical Center, finds himself. Clinical trials begin this fall on his Rotator Cuff Tensioning Repair Tool.
Mannava, now chief resident, developed the medical device to improve surgical repairs of rotator cuff tears. To produce the Rotator Cuff Tensioning Repair Tool, he collaborated with a variety of experts through Wake Forest Innovations, the commercialization arm of Wake Forest Baptist Medical Center. The medical center fosters an ecosystem of innovation that challenges researchers and clinicians to solve medical problems and provides the resources and connections needed to produce solutions that will improve medical care delivered to patients.
“Very few universities have the capabilities to translate basic science discoveries into improving patient outcomes,” Mannava says, “but transitioning discoveries into products and devices that can be used in medical care is one of the fundamental goals of biomedical research. This is what is unique about Wake Forest Innovations – there is an emphasis on studying diseases and the human condition, not just for the sake of science, but instead we study the human condition and innovate in order to ultimately benefit our patients.”
Mannava’s Rotator Cuff Tensioning Repair Tool adds an electronic load cell to an arthroscopic tissue grasper. The device holds a set amount of tension on tendons so that surgeons can reattach tissues at an optimal tension, which improves surgical outcomes.
The device is based on research Mannava conducted as part of the Physician-Scientist Training Program, established 15 years ago by L. Andrew Koman, MD, chair of the orthopaedic surgery department and a serial inventor in his own right. The seven-year program trains clinician-scientists to identify medical treatment problems and develop solutions that will improve patient outcomes.
As part of this program, Mannava discovered a need to improve treatment of rotator cuff injuries. Though many patients recovered from rotator cuff repairs and regained shoulder function, some still experienced pain and dysfunction after surgery, suffering from re-tears and requiring multiple surgeries for the same injury.
Mannava wanted to understand why these injuries did not heal optimally, so he researched the basic mechanisms of aging and tension in the healing of tendons. He studied animal models to investigate the effects of various repair and tensioning techniques on muscle function and tendon-to-bone healing.
From his basic science and preclinical research, Mannava made an important discovery: the amount of tension placed on tendons during surgery influenced healing outcomes and ultimately function. He wanted to develop a device that would effectively measure tension in tissues during surgery and hold that tension at a set level, allowing surgeons to better control this variable during rotator cuff repair surgery.
“You become a physician because you want to help people get better and back to their lives after an injury,” says Mannava. “However, if we all keep doing the same procedures that everyone else is doing, the field will never advance. Physicians need to analyze and critique every aspect of the patient care experience, including routine surgical techniques, in order to continually improve and deliver the most optimal health care experience.”
If he wanted to change how surgeons repair rotator cuffs, Mannava needed collaborators. He tapped into the expert knowledge and resources at Wake Forest to move his ideas forward.
Mannava worked with the biomedical engineering department of Wake Forest School of Medicine to confirm his preclinical findings. Using computational imaging and modeling, they scaled his preclinical research to apply to the human body. By using a validated surgical model of the upper body to simulate rotator repair surgeries, they confirmed that setting appropriate tension to tendons could improve surgical outcomes.
He approached Wake Forest Innovations about turning his scientific discovery into a life-improving reality by developing a device that would quantify tension during tendon repair. Mannava and two Wake Forest faculty orthopaedic surgeons, Christopher J. Tuohy and Michael T. Freehill, MD, worked with the Medical Device Accelerator, led by Kenneth Russell, director of medical device development at Wake Forest, to create a workable prototype.
“The Medical Device Accelerator is designed to help the innovative minds at the medical center connect with the partners who can help them develop their ideas into the products that will change healthcare,” says Russell. “Mannava worked with our all-star biomedical engineering department to create a device with incredible potential to help surgeons and their patients.”
The resulting Rotator Cuff Tensioning Repair Tool shows great promise in informing surgical decisions, improving post-surgical healing and reducing the incidence of re-tearing. By assessing repair needs on an individual basis and reducing the number of repeat surgeries, the device may also help reign in soaring healthcare costs.
Mannava’s participation with the Medical Device Accelerator at Wake Forest Innovations resulted in a medical grade prototype of the device that can be sterilized and used safely during surgery. Wake Forest Baptist’s Institutional Review Board approved the prototype for use in clinical trials, and Mannava and his colleagues are currently enrolling participants for the first phase of clinical trials.
“When you think about the pace of science, the ability to move from preclinical testing into actual clinical trials within six years is incredible,” says Mannava. “It is a testament to the environment of Wake Forest where people collaborate and work together, and as a result, we’ve moved rapidly through the invention process.”