With the number of joint replacement procedures growing at extraordinary rates, putting extreme pressure on already rising healthcare costs, the healthcare community must ensure that it is adequately equipped to meet the demand by preparing for the rising costs and making sure that there are enough orthopedic surgeons to handle new cases. For their part, medical device companies need to design and manufacture implants with longer life spans to avoid revision surgeries that add to healthcare costs, while exploring alternatives to traditional joint replacement procedures.Record growth in joint replacement surgeries represents a lucrative opportunity for implant makers, but with opportunity comes the responsibility to help hold down increases in healthcare costs before they overwhelm our collective ability to pay. Medical device companies are developing new materials and procedures and working with healthcare providers on preventive measures. Even so, more needs to happen to prevent joint replacement surgeries from overburdening the healthcare system.Joint replacements, which have been performed since the late 1960s, can be highly successful at relieving pain, repairing damage caused by arthritis, and helping people to function normally and remain active. According to the National Center for Health Statistics, about 43 million Americans, or nearly one in five adults, have some sort of arthritis pain. Knees, the largest joints in the body, are usually the most painful. Since obesity is also highly prevalent, cases of arthritis are beginning to onset at a much earlier age in overweight people.Number of Replacements SkyrocketingWith an aging baby-boomer generation, it should come as no surprise that the number of hip and knee replacement procedures have skyrocketed. The Nationwide Inpatient Sample (NIS) shows that primary hip replacements increased by 48%, from 153,080 procedures in 1997 to 225,900 in 2004. First-time knee replacements grew by 63% from 264,331 in 1997 to 431,485 in 2004. According to HCUPNet, 228,332 patients received total hip replacements in 2006, and 496,077 patients received total knee replacements.If these trends continue, an estimated 600,000 hip replacements and 1.4 million knee replacements will be carried out in 2015. It is estimated that by 2030, the number of knee replacements will rise to more than 3.4 million. First-time replacement procedures have been increasing equally for males and females; however, the number of procedures has increased at particularly high rates among people age 45-64 years.According to Datamonitor’s 2006 report, the US accounts for 50% and Europe 30% of the total procedures worldwide. The 2005 revenues for hip implants in the US were $2 billion and $1.4 billion in Europe, while knee implant revenues comprised $2.4 billion in the US and $774 million in Europe.Demand & Technology Drive Cost Increases With the increase in demand and improved implant materials and surgical techniques, the cost of these procedures is also increasing. According to NIS, Medicare was the major source of payment in 2004 (55.4% for primary hip replacements, 59.3% for primary knee replacements). Private insurance payments experienced a steeper increase. In 2004, the national bill for hip and knee replacements was $26 billion. Hospital cost accounted for $9.1 billion, and the amount of reimbursement was $7.2 billion (28% of hospital charges or 79% of hospital cost).Another study from Exponent, Inc. analyzed Medicare data for hip and knee replacements from 1997-2003. It was found that while procedural charges increased, reimbursements actually decreased over the study period, with higher charges observed for revisions than primary replacements. Reimbursements per procedure were 62-68% less than associated charges from primary and revision procedures. It is evident that joint replacements have the potential to be highly lucrative, but the burden on patients and our healthcare system must also be considered.Behind the Growth TrendAn aging population and increased incidence of obesity are primary causes for the increase in joint replacements. Nearly 65% of the US population is overweight, and arthritis is highly prevalent among this group. With more patients receiving joint replacements at an earlier age, there is much higher probability they will outlive their artificial joint.A recent study in Wales tracked joint replacement procedures since 2003 and found a revision rate of 1-in-75, which was considered to be a fairly good score. In the US, 40,000 knee revisions and 46,000 hip revisions were performed in 2004. However, knee revisions are expected to increase sevenfold, and hip revisions to more than double by 2030.Revision surgeries are problematic for several reasons. In addition to the extra recovery time for patients, revisions are tougher operations that take longer and cost more. There is often a reduced amount of bone to place the new implant and there is a much higher complication rate.Why Implants FailWith hip replacements, the most common problems are postoperative instability and repeated dislocations. Surgeons must consider many risk factors before the initial surgery, including age, gender, motor function disorders, dementia and prior hip surgery. The surgical approach can also affect the risk for dislocation and leg-length discrepancy, so proper pre-operative planning is a must.Components design and positioning may also contribute to instability. Dislocations are often caused by movement outside the normal range of motion, so it is important for patients to take the proper precautions following surgery. A study by the Mayo Clinic showed that in the case of repeated dislocations, the hospital fees for treatment and revision surgery end up costing, on average, 148% of the cost of the initial replacement. The decision to undergo a revision surgery is typically made based on repeated dislocations and the patient’s health. Patients that have undergone previous hip surgeries or have poor abductor muscles are at greater risk for failed revisions.Revisions of knee replacements may be required when patients experience infection, osteolysis, implant loosening or misalignment, knee injury or chronic progressive joint disease. Decisions to undergo revisions are made based on previous knee surgeries, current health and radiographic examinations. Patients with poor bone quality, unresolved infection, peripheral vascular disease or poor quadriceps muscles or extensor tendons are at greater risk for a failed revision.Preventive MeasuresWith the unprecedented growth in replacement procedures, measures must be taken to prevent this phenomenon from overwhelming our healthcare system. This can be accomplished through better preventive care, alternatives to total replacements, and by ensuring that primary replacements are successful. Reducing obesity and treating arthritis at earlier stages will help reduce the numbers of procedures. In addition, many have called for a national joint replacement registry such as those in Australia, Great Britain, Norway, Denmark, and Sweden, which track high failure rates associated with some joint replacement procedures.Alternative procedures are available that have improved dramatically over the past 10 years. For example, partial replacements are less-invasive, with smaller scars and shorter healing times because only the diseased compartments are replaced. Minimally invasive procedures are available for total replacements in some patients. There are also new options available for women needing total knee replacement, known as “gender-specific” knees that are slimmer and contoured to more closely imitate the female anatomy. Hip resurfacing is another procedure gaining in popularity because it conserves more bone than a traditional total hip replacement. This type of implant will last longer than a traditional hip replacement.New biomaterials and component designs also increase the lifespan of implants, and computer-assisted surgery can improve the success of joint replacement by allowing more accurate and precise implant alignment. Several studies have shown this type of procedure to be more cost-effective by preventing the need for revision.Looking AheadFor medical device companies, the record growth in joint replacement procedures presents a lucrative opportunity. However, manufacturers need to work with the medical community to help ease the burden of this epidemic by increasing the success and longevity of their implants and exploring alternatives to the traditional joint replacement procedures.Undoubtedly, national joint replacement registries have proven useful in other countries. The medical community needs to demand that a registry be put in place in the United States, and it needs to do a better job of educating society on prevention. It is important that the medical community, including device companies, come together with a plan for preventing the potential burden this overwhelming surgical load could have before it takes a toll on our healthcare system.