Data registry finds younger orthopedics patients are no healthier than older ones

Print 13 April 2015
Varun Saxena / FierceMedicalDevices

The Framingham Heart Study has revolutionized cardiology over the decades, leading to insights like the dangers of smoking in the 1960s, elevated blood pressure in the 1970s and more recently, genomic risk factors. Another Massachusetts study is underway, with the intention of becoming the equivalent study in the orthopedics arena, according to Dr. David Ayers, chair of the orthopedics department at the University of Massachusetts Medical School in Worcester.

Like its cardiology counterpart, the Force-TJR data registry is following patients for life--30,000 from 150 hospitals across the nation--thanks to a four-year, $12 million grant from the federal Agency for Healthcare Research & Quality.

At the American Academy of Orthopaedic Surgeons conference,FierceMedicalDevices reported on the efforts of joint replacement players like Zimmer ($ZMH) to reach out to younger patients. Ayers confirmed that those under 65 are the fastest growing segment of the market, but said the subgroup doesn't fit the industry stereotype of elderly athletes who are looking to preserve their mobility, citing registry data presented at the same conference about body mass index (BMI).

"At one point they may have been athletes, but at this point they're actually heavier, and have a higher BMI than the older patients," Ayers said in an interview. He added that the younger cohort has equally severe arthritis at the site of the diseased hip or knee joint, and worse arthritis overall than those over 65.

The industry was surprised to learn this, Ayers said. The orthopedics companies are also impatiently awaiting the results of planned head-to-head comparison studies of their implants.

"There are differences (between orthopedic implants), but they aren't necessarily correlated with the cost of the implant," Ayers said. The orthopedics players will be happy to hear that, for the perception that there isn't much difference between competing implants is leading to the commoditization of their products as payers, like hospitals, negotiate based on price alone.

The head-to-head comparison studies will be publicized next year, Ayers said. That's when we'll find out which companies are the real winners and losers from Force-TJR.

In addition, the Force-TJR researchers are attempting to modify the Medicare reimbursement methodology. Under the Affordable Care Act, hospitals are penalized if they have a high rate of readmission following various procedures, including orthopedic surgery.

Ayers said the Centers for Medicare & Medicaid Services doesn't risk-adjust the readmission data appropriately to take into account differences between hospitals, such as that in the severity of the patients' conditions that different institutions treat.

Force-TJR also collected data on the patients' smoking status and "preoperative function," including not only the level of injury to their diseased joint, but also cardiac and lung function. Ayers said the data show that those metrics are a strong predictor of risk, and should be incorporated into the fed's decision-making regarding whether to penalize individual hospitals for having a high readmission rate.

CMS already risk-adjusts the readmissions data, Ayers said, but not sufficiently. For example, the agency collects data on whether an orthopedics patient's BMI is or more or less than 40. But the Force-TJR data registry makes it a continuous variable, meaning a patient's actual BMI is recorded for future analysis.

Ayers said the agency acknowledged that the additional information is valuable, but data collection difficulties present a challenge to their adoption.

The difference between Force-TJR and other orthopedics registries is the breadth of data collected, including patient-reported outcomes like subjects' pain levels before and after surgery. Other registries collect only "level I" data focused on the implant, such as its manufacturer and size, but excluded patient-level data, Ayers said.

Force-TJR is looking to expand its network of participating hospitals so that it can gather even more data. Ayers said that in return for a subscription fee and promise to gather and provide the registry with the required data, hospitals can access the registry's database about patient-reported outcomes and implant quality.

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