It never was, really. The pain truly had little, if any, connection to motive.
For years, Peter Jolly bristled at the thought of fixing his damaged knees. He wasn’t comfortable with all the uncertainty about joint replacement longevity, nor was he willing to swap out a still-functioning (barely) biological body part for an artificial one. The man-made joints would have to be just as good—or better than—Mother Nature’s, and last just as long for Jolly to even consider the notion of a knee replacement.
Ron Ivy had the same expectations for his replacement hips. Before arthritis rendered him mostly idle, the 53-year-old petroleum engineer countered his sedentary professional lifestyle with daily gym workouts (weights and elliptical work), tennis or racquetball games, golf outings, wade fishing, and bird hunting. “I was very active,” he admits.
All those activities, however, gradually subsided as the wear and tear on Ivy’s hips worsened. Eventually, the hip pain and stiffness became so bad that simple actions like standing up and sitting down became agonizing chores.
“It hurt to get out of my desk chair,” the former competitive tennis player recalled in an online video. “I’m normally up and down a lot, and it got to where I would hardly get up from my chair. It hurt too much to get up and walk around.”
Jolly couldn’t walk without pain either, courtesy of decades-old knee injuries. The 71-year-old British schoolteacher injured the meniscus in both knees, damaging one while running (he was a cross-country runner and sprinter in his early 20s) and the other while lifting something he shouldn’t have picked up.
“I could feel the pain, which I’d not experienced before, and I tore my right medial meniscus,” the physics and physical education instructor said. “My other meniscus, left leg, I tore a decade later...I was in real pain.”
Indeed, the pain from a torn meniscus can be excruciating, but the long-term effects can be equally as agonizing. Small rips usually heal in four to eight weeks depending on their position and severity, while larger tears often require surgery. Deep (unstable) tears—those extending completely through the meniscus—can spawn serious long-term knee problems, as they tend to pull apart before generating any significant healing. Consequently, the damaged meniscus’ constant rubbing on articular cartilage can cause wear and tear on the surface, leading to eventual joint degeneration and/or arthritis.
Hip arthritis evolves in a similar fashion, typically resulting from perpetual wear and tear of the femoral head against the pelvic acetabulum. A common by-product of middle age, the progressive disorder assumes various forms; osteoarthritis is the most widespread, and rheumatoid arthritis is perhaps the most disabling, as it erodes articular cartilage and causes full-body joint lining swelling that eventually destroys the joint surface.
A long-lasting condition, rheumatoid arthritis serves up a one-two punch of dual joint pain and deformity (unlike osteoarthritis, which affects only one bone coupling set at a time).
Such a double whammy can be debilitating for rheumatoid arthritis victims. Ron Ivy’s once-active life took a nosedive as the condition slowly obliterated the articular cartilage on both hip joints. “I had to stop doing all those things [I used to]. It wasn’t comfortable. I gained weight,” he said. “Everything was going in the wrong direction. I had to get it fixed.”
Peter Jolly’s body needed fixing too, much to his dismay. The aging Baby Boomer’s decaying knees were increasingly interfering with family bonding time.
“Worst of all, it was being reluctant to lift my grandchildren,” he recollected. “My wife and I have spent a lot of time looking after our grandchildren but when you feel you’re not quite doing it properly, or the amount that you can give to it is being compromised because of the condition of your knees and the pain in them...then that’s...that’s very compromising and disappointing.”
Cognizant of his misgivings but sympathetic to his plight, doctors recommended that Jolly replace only one portion of his worn-out joints through a partial (unicompartmental) knee replacement, a minimally invasive procedure that entails switching only one of the knee’s three compartments for a prosthesis. The most common compartment replaced is the inside (medial), though the patellofemoral/anterior (knee cap) and outside (lateral) portions can be traded off if necessary.
Such compartmental exchanges are conducted through a small incision (four to six inches), usually in an outpatient setting. The minimally invasive nature of these procedures has become popular with patients, as these surgeries have generally been associated with more rapid recoveries, fewer complications (blood loss, transfusions, blood clots) and a greater satisfaction compared with total knee replacements.
Traditionally, partial knee replacements were performed mostly on older patients with relatively healthy ligaments, good range of motion, and little to no (joint) deformity, but the patient demographic has since grown to include younger folks experiencing pain and symptoms in one part of the knee.
“My surgeon recommended that I might have half knees, but I had been in denial about that. I had declined because I was not sure about their longevity,” Jolly said. “And he said, ‘Look, Zimmer Biomet has got this Persona Partial Knee which would suit your purpose.’”
Launched in August 2017, Zimmer Biomet Holding Inc.’s fixed-bearing implant is designed to give patients a fit customized to their anatomies. That customization was facilitated in development through the company’s ZiBRA Anatomical Modeling System, which analyzed thousands of bone scans across a diverse global population.
Zimmer Biomet’s Persona Partial Knee System features various sizes with improved options that mirror the native tibia; better shape matching for improved tibial coverage (intended to prevent subsidence); and improved patella flange geometry aimed at reducing soft tissue irritation and contact with the patella.
The Persona Partial Knee system replaces the fixed bearing knee that was divested to Lima and Smith & Nephew as part of Zimmer’s 2015 merger with Biomet.
“I went in and had it done. I’m back from [operating] theater and I’m doing leg raises, and in the space of 24 or 36 hours, I’m passing a staircase test and being sent home with a pair of elbow crutches,” Jolly recounted in a video posted on the Zimmer Biomet website. “The confidence that it gives me to be able to lift my biggest grandson who is nine and chunky, and is going to be a rugby lock, I think, and put him on my shoulders and prance about and be comfortable with it...that makes me cry. They [Zimmer Biomet] completely changed what I could do.”
Ron Ivy experienced the same result through direct anterior hip replacement, a minimally invasive technique that approaches the body’s largest weight-bearing joint from the front rather than the back (posterior) or side (lateral). Surgeons access the hip via a 3- to 4-inch incision and implant the new joint by moving muscles aside along their natural tissue planes, without detaching any tendons.
Like partial knee replacements, the direct anterior approach often results in quicker recoveries, less pain, and more normal joint function after surgery. Also, since no tendons are detached during the procedure, hip precautions typically are not necessary, thereby allowing patients to return to normal daily activities shortly after surgery with a reduced risk of dislocation.
Ivy’s return to normal was exceptionally quick: Before the procedure, he could only walk with a cane, but soon after receiving his new hip, he was walking to the bathroom without assistance. Not long after that, he was walking half a mile on his own.
“It felt so good,” Ivy said. “I had not walked a half mile the whole prior year [before surgery]. I had felt so bad, you cannot believe it.”
Ivy could hardly believe it himself. He had suffered for so long with his arthritic hips that he almost forgot how good it felt to live a pain-free life—to walk without limping, to drive without wincing, to sleep without waking (constantly), to travel without compromise.
Such promise prompted Ivy to undergo a second direct anterior hip replacement upon his initial recovery. The results were the same, fostering his return to the gym, tennis court, golf course, waterways (boating), and dance floor.
“People used to ask me what was wrong: You have problems walking. Is it your hip?” Ivy remarked. “Now, I walk, get up from my chair, get up and down off the floor, dance, play golf, and much more. It’s been a remarkable story.”
Remarkable in both outcome and potential. Ivy isn’t the first patient to benefit from minimally invasive surgery (MIS), nor will he be the last: The worldwide market for such procedures (all applications) is projected to grow 9.6 percent annually through 2026 to reach $33.8 billion, according to Acumen Research and Consulting data. Orthopedics is projected to capture the largest market share during the forecast period, given its large volume of surgeries, the development of minimally invasive procedures for various musculoskeletal injuries, and the introduction of MIS approaches in hip and knee replacements. Nevertheless, increasing numbers of cardiothoracic disease patients most likely will propel the sector at the fastest rate, Acumen statistics predict.
Geographically, North America is the world’s MIS market leader, and though the continent is expected to retain that title through 2026, its growth is presaged to be eclipsed by Asia, where patient volume, OEM investments, rising healthcare expenditures, higher disposable income, improved technological adoption, and better support for non-invasive device development and commercialization will result in significant market share gains.
“We will continue to see incremental improvements of existing minimally invasive technologies for many years to come, and the expansion of those technologies globally as emerging markets develop their health care systems,” noted Jeff Wyman, vice president of Marketing, Sports Medicine franchise, at Smith+Nephew. “As these markets develop, the benefit of technologies which deploy procedure efficiency with strong economic and clinical value to provider networks will fuel this trajectory.”
Also contributing to that trajectory is the very nature of the procedure itself: MIS is simpler and far less traumatizing to the body than open surgery. The latter necessitates sizeable incisions for internal access (five to six inches for the spine; 10-12 inches for hips), whereas MIS requires significantly smaller cuts (three to four inches for knees, two one-inch openings for spinal fusions). Open surgery also entails cutting through large areas of tissue, which requires more OR time and longer hospital stays; MIS, by contrast, leaves tissue unscathed, allowing for faster procedures and less time in surgery.
Minimally invasive surgery also is associated with less pain and discomfort. Studies have shown that MIS patients report less post-operative discomfort and require smaller doses of pain relievers than those who have undergone traditional surgery. Moreover, since smaller incisions lead to less blood loss, fewer complications, and faster recovery times, MIS patients are more likely to return to their normal routines much sooner than their open-procedure counterparts.
And those rapid recoveries can save the healthcare system some significant greenbacks—potentially hundreds of millions of dollars, according to a 2015 Johns Hopkins analysis of U.S. surgical outcomes. The analysis concluded that American hospitals could collectively prevent thousands of post-surgical complications and save $280 million to $340 million annually by using an MIS approach to appendix, colon, and lung procedures.
Similar savings are possible through minimally invasive (MI) techniques in orthopedics, especially in spinal repair. A study published last fall, for example, cited a cost savings range of $8,731 to $9,295 through MI transforaminal lumbar interbody (TLIF) surgery, with reported direct hospital cost savings of $1,758 to $2,820 per patient. The study estimated that minimally invasive TLIFs can spare the U.S. healthcare system $98,974 per patient, mostly through indirect costs (i.e., lower surgical site infection risk). And while there was no reported difference in economic outcomes for MI TLIFs using unilateral vs. bilateral screws, investigators did find a 35 percent cost savings when only unilateral screws were used in the procedure.
“With an aging population continuing to drive higher demand and disproportionate growth of minimally invasive spine surgery, the field of spine surgery remains a unique target in the transition to value-based care,” the Current Reviews in Musculoskeletal Medicine study states. “While spine surgery has benefited from new medical technologies, including minimally invasive surgery, these technologies may be a key driver in rising U.S. healthcare costs. As such, MIS procedures and spine surgery, at large, need to clear an economic value threshold...”
That threshold is rather significant for MI scoliosis corrections—an estimated $25,868 to $122,082. Investigators compared costs associated with single-level anterior cervical discectomy and fusion compared with MI cervical posterior fusion and found the minimally invasive option to be roughly 89 percent less expensive due to lower operating room and supply charges.
Data shows NuVasive Inc.’s X360 System can save hospitals nearly $5,000 per patient, mostly through indirect costs like more efficient surgeries, less anesthesia, and reduced intraoperative risk. Touted as a “comprehensive approach” to lateral single-position spine surgery, the X360 System integrates the company’s XLIF, XALIF, and XFixation procedures as well as the Pulse surgical automation platform to enable multiple surgeries to be performed from the lateral position throughout the entire procedure. Since the patient is never repositioned, the X360 approach can reduce operating room time by up to 60 minutes, clinical documentation indicates.
NuVasive’s XLIF (eXtreme Lateral Interbody Fusion) surgical technique is a MI procedure that approaches the spinal column from the side rather than the front or back. Such an entry enables physicians to avoid cutting or damaging nerves between the incision site and spinal discs, and can be employed to treat various pathologies, including degenerated discs or facet joints causing unnatural motion; degenerative spondylolisthesis; and degenerative scoliosis.
The X360 system extends NuVasive’s lateral single-position surgery approach, helping the company accelerate the adoption of its MIS technologies. The system now aligns all of NuVasive’s lateral procedures and innovations in one integrated approach, enabling surgeons to treat more conditions and spinal levels from one position.
“Our main goal with the design of minimally invasive technologies is to make minimally invasive surgical procedures safer and more reproducible in the hands of a variety of surgeons with different training and skill sets,” noted Ryan Donahoe, vice president of Spine R&D at NuVasive. “Now, we are developing enabling technologies, such as the Pulse platform, that combines 3D navigation and neuromonitoring technologies integrated with instruments and implants that all work in concert to help a surgeon perform minimally invasive surgical techniques. Pulse is the first single platform to include multiple technologies designed to help surgeons adopt more efficient, less disruptive surgical approaches in all spine procedures. Engineered to improve workflow, reduce variability and increase surgical reproducibility, Pulse addresses a broader range of clinical challenges in the operating room compared to any other enabling technology in the spine market. These systems provide feedback in real-time to help surgeons navigate to the spine, especially in minimally invasive techniques where direct visualization to the spine is limited. These technologies aim to improve the safety and efficiency of our procedures and shorten the learning curve as surgeons transition from open to minimally invasive procedures.”
Those transitioning surgeons have plenty of options at their disposal, too, as most major orthopedic OEMs offer MIS implants and instruments for treating spinal and other musculoskeletal conditions. In February, an Englewood, N.J., surgeon became the first in the United States to implant Globus Medical Inc.’s HEDRON IA in a minimally invasive outpatient procedure. The 3D printed integrated ALIF spacer leverages anchors or screws for vertebral body fixation; the spacers feature a biomimetic porous scaffold designed to promote bone formation onto and through the implant. Unlike the first-generation 3D printed implants, HEDRON strikes a balance of strength and porosity through a sturdy frame and a pore size similar to trabecular bone. In addition, the spacers have shown significantly more bone ingrowth in animal models at six weeks post-op compared with PEEK (polyetheretherketone) and titanium implants.
Globus’ MIS spine solutions also include AERIAL Interspinous Fixation, the CREO MCS and MIS Stabilization Systems, the RISE IntraLIF Spacer, and the SI-LOK/SI-LOK Select Sacroiliac Joint Fusion Systems.
DePuy Synthes Inc., Medtronic plc, Stryker, and Zimmer Biomet all have extensive portfolios of MI spinal technologies. “We have a responsibility to continue to innovate to make spinal fusion surgery less invasive for patients and less complicated for surgeons,” a DePuy executive asserted in touting the company’s VIPER PRIME System (a pedicle screw inserter tool).
Integra LifeSciences Corporation’s MI spinal implants/ instrument portfolio is now the official property of its 2014 spinout, SeaSpine Holdings Corporation. Integra formed SeaSpine to focus on extremities and wound care innovations, neurosurgery advancements, and instrumentation. The company bolstered its neurosurgical portfolio last year with the purchases of Arkis Biosciences Inc. and Rebound Therapeutics.
Arkis’s product lineup featured the CerebroFlo external ventricular drainage catheter with Endexo technology and a permanent additive designed to reduce the risk of catheter obstruction from thrombus formation.
Rebound developed single-use, disposable devices used for access, imaging, and visualization during minimally invasive surgical procedures; its technologies featured integrated optics and illumination that interface with existing operating room monitors. Rebound’s Aurora surgiscope system and Aurora Evacuator are used for various MI neurosurgical procedures.
“Rebound’s MIS technological platform is a natural addition to our portfolio of neurosurgical products and will expand our therapeutic-focused offerings,” Dan Reuvers, corporate vice president and president of Integra LifeSciences’ Codman Specialty Surgical division, said upon announcing the September 2019 acquisition. “We are eager to further develop Rebound’s MIS technologies to help surgeons improve the standard of care for neurosurgery patients.”
Smith+Nephew used the same strategy to improve the standard of care for joint replacements, purchasing privately held healthcare equipment company Ceterix Orthopaedics Inc. last January in a deal worth up to $105 million. The acquisition gave Smith+Nephew ownership rights to Ceterix’s NovoStitch Pro Meniscal Repair System, a tool that enables surgeons to arthroscopically repair horizontal, radial, complex, bucket handle, and root and vertical tears. The device—cleared for sale in the United States—complements the company’s FAST-FIX 360 Meniscal Repair System, which is used for treating vertical tears.
“Products like our NovoStitch Pro Meniscal Repair System are a great example of how new technologies can expand the possibilities to treat a specific pathology like meniscal tears,” Wyman said. “In the past, healthcare professionals may have simply resected a meniscus or only repaired simple tears—with this new technology, more complex tear patterns can be addressed in a minimally invasive approach quickly and reproducibly.”
“Minimally invasive surgery, more commonly referred to as sports medicine or arthroscopy, is a growing sector in the medical device industry,” he continued. “As the desire to promote health and wellness through physical activity increases, injuries and musculoskeletal conditions are occurring more frequently. Patients desire to have their meniscus repaired instead of resected. Smith+Nephew’s ‘All Tears All Repairs’ portfolio expands the possibilities of meniscal repair regardless of a surgeon’s preferred approach, location or type of operable meniscal tear. Studies have shown that 96 percent of meniscal repair patients return to pre-injury activity levels. However, only 15 percent of meniscal tears are repaired.”
Jolly was lucky then, in more ways than one.