A 3D-designed primary total hip replacement system has been successfully demonstrated by Conformis, Inc., a medical technology company that offers patient conforming joint replacement implants. The surgeries were performed at the JFK Medical Center in Atlantis, FL by Gregory Martin, M.D., founder of Personalized Orthopedics of Palm Beaches, Bonyton Beach, FL.
With a surgical design team and experience in automated 3D printing and additive manufacturing, Conformis was able to bring the Hip system to fruition and offer a customized surgical option for hip implants.
“The design process produces specific individualized pre-navigated cutting guides and implants. An acetabular reaming system has also been developed,” said Mark Augusti, CEO and president of Conformis. Augusti hopes with this launch they can better serve the $7B hip replacement market.
The Hip System is similar to the design process for the Conformis Knee technologies, in that the Conformis Hip System uses proprietary advanced imaging and design software to design and manufacture the implant. This system had several challenges when proceeding with the development.
“The first was figuring out how to best preserve what we know works in total hip arthroplasty, while solving what doesn’t work. This included incorporating time tested materials, implant geometry, and fixation surfaces, while at the same time creating a patient specific surgical plan and implant,” said Dr. Martin of Personalized Orthopedics. “We must remember that unlike knee replacement, which has sophisticated instrumentation, total hip replacement has traditionally been an unguided procedure highly dependent on the training, skill and experience of the surgeon. We set out to change this and create a reproducible procedure that is guided with patient specific instrumentation, and ultimately, provides the patient with an implant that was made for them and fits them in every dimension.”
After a patient’s CT scan is converted into a three-dimensional computer model, the measurements of each patient’s anatomy is converted into an individualized, pre-operative surgical plan. Surgeons can then collaborate with Conformis during the surgical planning process in order to design the most optimal hip system for the patient.
Dr. Martin said this technological customization is something that patients are more willing to try and excited about.
“It is interesting. Patients, once they hear they can have a hip or knee made precisely for them, demand it. They won’t settle for anything less,” said Dr. Martin. “The challenge is in convincing surgeons to change. Many surgeons are rightfully cautious about embracing new technology. However, over time as outcomes data is collected, and they start to see some patients with the technology doing better, they start to have a more open mind and start to change.”
Each element of the Conformis Hip System is designed to fit the patient and the system is then delivered directly to the hospital or surgery center in a single patient-labeled kit. Patient conforming, single-use, 3D printed cutting guides are also included.
Customizing how surgery is performed is something Dr. Martin said will become more prominent. With an element of customization, surgeons can be more precise with their surgical plan proposal.
“It just makes sense that eventually all elective surgical implant procedures will involve customization. As manufacturing costs decrease with 3D printing, and particularly as 3D printing for metals improves, I believe all implants will be customized,” said Dr. Martin. “Why wouldn’t we demand that our medical devices fit precisely if the technology is there to do so?”