Conformis reported that its hip system is the first ever 3D-designed primary total hip replacement system in the United States. Image courtesy of Conformis.
The first two total hip replacement surgeries using a new 3D technology were recently performed by Gregory Martin, MD, founder of Personalized Orthopedics of the Palm Beaches, at JFK Medical Center, Atlantis, FL. The Conformis Hip System includes specially made implants that match a patient’s specific measurements, as well as customized instrumentation that the surgeon uses to guide him or her during the procedure.
As Conformis previously did with its knee system, the hip system merges the attributes of its time-tested implants with new capabilities that enable the devices to be matched with the individual patient’s anatomy, Martin said in an interview with MD+DI. “This is combined with a guided surgical technique, incorporating 3D-printed patient-specific instrumentation,” he said.
The manufacturing process begins with a CT scan of the patient, which is then submitted to Conformis. Within a few weeks, the company sends the surgeon proprietary software called iView. “This iView includes the information generated as part of the 3D design process we use,” said Lisa Donnelly, senior vice president of global marketing at Conformis.
The iView shows anatomical views with and without the Conformis implants, so the surgeon can see how the implants interact with the patient’s anatomy. The design process provides the surgeon with the “best fit” implant components with certain patient-specific geometries designed into them. The iView also provides advanced anatomical information to the surgeon that he or she could not obtain from traditional 2D templating. Once the surgeon accepts the final plan, implant and instrumentation manufacturing begins.
The system also features a new procedure for acetabular reaming—a process that uses power to shape the bone to match the implant cup geometry. Conformis’s system reduces the number of steps involved with traditional reaming. “And ours is disposable, which potentially reduces infection due to biological contamination, as each patient receives a sharp, clean reamer every time,” said Donnelly. Current reamers are reusable, requiring cleaning and sterilization after each surgery, which she said can carry significant costs.
The entire process from CT scan to surgery can be measured in weeks, said Donnelly. The system is delivered directly to the hospital or surgery center in a single, patient-labeled kit, eliminating the need for excess inventory. Patient-conforming, single-use 3D-printed cutting guides are also included.
“Traditionally, hip replacement has been an unguided operation, heavily dependent on the training, skill, and experience of the surgeon,” said Martin. “What the reaming system and all the instrumentation provided aim to achieve is to turn hip replacement into a guided operation that can be reproduced and has checks and balances.”
The system was cleared in June 2017, and in the time between clearance and the first surgeries, manufacturing validations for many of the individual processes used to create the hip system were completed. “This is typical of products cleared under the FDA process, which does not require manufacturing to be completed to receive clearance,” said Donnelly. “However, these validations must be completed prior to commercial release.”
The company plans a limited launch of anywhere from 100 to a few hundred procedures through 2019, said Martin. “During that period, a select group of surgeons, including surgeons on the design team and some other select surgeons, will work to give feedback on the surgical technique so it can be made as efficient as possible by the full commercial launch,” said Martin. The commercial launch will be announced in 2019.