Knee and hip surgeries present a number of challenges for both surgeons and patients alike. Surgeons use sight and good judgment to determine the correct angles for implant positioning, which can only be verified by X-ray post-operatively. At this point, an additional surgery is required to make even minor angle adjustments. Patients can experience residual pain from the procedure and improper alignment, although this pain is often still preferable to arthritic joints. In addition to these exiting challenges, with a trend towards performing knee and hip surgeries in younger patients, there is a need for high-precision surgical techniques and robust implantables that fit and perform better and last longer than ever before. Addressing this need is OMNIlife science, Inc (OMNI), a developer of orthopedic procedures and implants. We had a chance to speak with OMNI’s CTO (former President and CEO), George Cipolletti, about the orthopedic innovations coming out of OMNI.
Michael Batista, Medgadget: Give us a brief background on OMNI and yourself.
George Cipolletti: Although I have been the CEO of OMNI for eight years, I am a bioengineer by training, with experience developing devices for cardiovascular, neurosurgical and orthopedic surgery, working with both large companies like Johnson & Johnson and Baxter as well as small private companies. Fifteen years ago, I had the opportunity with two partners to start our own company, focusing on designing and manufacturing joint replacement systems. Our goals were straightforward: provide devices that solve the vexing problems faced every day by orthopedic surgeons and their patients, and listen to the needs of the customer so we could provide the level of personal attention that large multinationals can’t match. With this philosophy, we started with one hip replacement system and a handful of cases each month. We have now built a business that offers a full line of hip and knee replacement systems that are used in more than 1,000 cases each month in seven countries around the world. With more than 120 employees and locations in the U.S., France and New Zealand, we are the only company to offer navigated robotic total knee replacement.
Medgadget: What is OMNINAV and how is it used for knee and hip replacements?
Cipolletti: The most sophisticated technology available in total knee replacements is the navigated robotic system, OMNINAVTM. Patients have a lot to discuss with their physicians regarding options available to them for their joint replacement. Navigation is helpful for alignment of the prosthetic joint and reported to provide an advantage in longevity of the joint replacement for the recipient. The computer assists the surgeon in making intra-operative decisions through the use of 3D imaging of the patient’s joint. This option does not require the use of intramedullary rods that are associated with higher rates of blood loss. The OMNINAV offers an integrated, navigation-driven robotic option for knee replacements where the surgeon can perform virtual surgery before making any bone cuts and have the robot follow the surgeon-controlled plan for the knee replacement. There are minimally invasive surgical techniques available that offer smaller incision lengths, less tissue disruption, less muscle and tendon disturbance, which offer the patient the advantages of earlier recovery and faster rehabilitation with potentially less pain. For hip replacements, the direct anterior approach might be an option that the surgeon might choose that offers all of the advantages of these minimally invasive techniques. For some patients, the surgeon might offer same-day surgery, eliminating the need for a hospital stay overnight.
Medgadget: What are the biggest challenges in surgical orthopedics and how do your products address these challenges?
Cipolletti: Patient satisfaction and expected recovery times are some of the biggest challenges an orthopedic surgeon faces. Patients today range from more active, younger patients to active, aging baby boomers. Patients want pain-free mobility restored and a fast return to their favorite activities, including a variety of sports. The high activity of these patients puts more demand on the prosthetic joint. Fortunately, OMNI offers many technologies to assist the surgeon with this high-demand patient population. The OMNI ARCTM Hip System conserves femoral neck bone and blood supply to the proximal femur during hip replacement, providing a durable new hip joint. The OMNINAV, the only navigated robotic knee replacement technology, coupled with the options within the APEX Knee SystemTM line, integrates the orthopedic surgeon’s surgical technique for knee replacement while providing optimal implant alignment and joint kinematics. The result is a knee replacement that is perfectly fit for each patient, designed for a faster recovery and return to normal activity.
The orthopedic surgeon is also challenged by many clinical hurdles, including deep vein thrombosis (DVT) and blood clots that can form after surgery in some patients, infection, dislocation, implant loosening and polyethylene wear. The surgeon has many assets to help manage these challenges, including advanced technologies in polyethylene offered exclusively by OMNI. The ApeX-LNKTM Highly Cross-linked Polyethylene is a time and clinically tested material used with OMNI’s hip replacement systems that starts strong and stays strong throughout the life of the implant. Studies conducted over five million cycles show that compared to standard polyethylene, the ApeX-LNK Highly Cross-linked Polyethylene achieved an 88 percent reduction in wear. Polyethylene wear is a major contributor to implant loosening, as is implant alignment.
Medgadget: Tell us more about some of OMNI’s orthopedic implantables?
Cipolletti: The APEX Knee SystemTM brought to market many unique features and benefits for orthopedic surgeons. Implant fit is very important, as each patient’s anatomy is unique. Contemporary implant systems usually force a trade-off for the surgeon between gaining as much coverage of the femur with a standard implant followed by the requirement to use the same size tibia, which might compromise fit by being too large or too small to fit optimally. The APEX Knee System is based upon a rigorous anthropomorphic scientific study of knee bones that led to the creation of specific left and right knee implants with shapes that mimic the natural bone anatomy with nine sizes. The result is the surgeon can fit each patient near perfectly with no compromises. An additional feature includes matching the polyethylene tibial insert to the femur versus the tibial base plate. This is designed to allow the femur to stay in contact with the polyethylene insert throughout the range of motion without edge loading, thereby reducing stress on the insert, while allowing optimal coverage of the resected tibia. Additionally, the tibia tray is asymmetric, which provides coverage to the resected surface and places the tray in optimal position with no need to rotate it to attain better fit. The system is a high-flex design and is offered with cemented and porous coated options in 18 sizes with six tibial insert options in a range of thicknesses. And finally, the surgeon can convert from a cruciate retaining knee procedure to a posterior sacrificing procedure through the use a single reamer guide jig that fits over the resected femur chamfer cuts and the use of a PS reamer to create a cylindrical space for the tibial eminence.
The OMNI ARC Hip System allows surgeons an option for younger, higher-demand patients of preserving the femoral neck and its blood supply to support a hip replacement that is stable. The OMNI ARC Stem fits well with a direct anterior approach and is bone-sparing and muscle-sparing with many bearing options available. Traditional total hip replacement resects the femoral neck bone, is very invasive and is accompanied by longer recovery periods and hospital stays. The ARC system achieves strong stability early and is designed to allow patients to recover more quickly and discharge sooner than traditional hip replacements.
Medgadget: How do OMNI’s products influence patient lifestyle and quality of life after surgery?
Cipolletti: The OMNINAV supports the procedure called OMNIPlasty. The system is designed to offer a reduced length of stay in the hospital and less blood loss with an earlier range of motion. With the surgeon’s ability for intra-operative adjustability and bone-morphing technology, there is no need for patient exposure to radiation for pre-operative films or studies.
Medgadget: Does OMNINAV have applications to other procedures requiring specific orientations?
Cipolletti: OMNINAV is applicable to large joint replacements of the knee and hip. In the future, the technology will assist surgeons with extremity replacements such as the shoulder, wrist, hand, ankle and other foot interventions. The technology has the potential to help with anterior cruciate ligament replacement with sports medicine physicians and will be designed for use in spine interventions for patients suffering from severe back pain.
Medgadget: What’s next for OMNI?
Cipolletti: We will be working hard to transform the orthopedic operating theater from the current “hammer and chisel” concept to an environment that employs state-of-the-art digital systems to optimize the positioning of the implants and the soft tissue envelope around the device. This will allow for more rapid recovery, more reproducible results and higher patient satisfaction.
Link: OMNI homepage…