Research Summary Research topic: Compared patients who participated in the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT), with those who chose not to be part of the study.
Research results: Both participating SPRINT study patients and patients who were not part of the study showed lower than expected reoperation rates, but non-participants were moderately more likely to undergo reoperation before the six month protocol required for participants. The difference was not statistically significant.
Patient care application of results: Evidence that following the results of patients who do not enroll in trials as well as those who are enrolled can strengthen overall research by adding new or previously unexplored information.
Simplified patient care application: Better evidence for new treatment protocols or changes to clinical practice.
Making an Impact on Patient Outcomes
OREF grants enable investigators to explore complex questions
When she was in medical school, Carol A. Lin, MD, wasn’t interested in orthopaedics. She thought cardiac or pediatric surgery would impact patients’ lives in the most profound way. But that was before she met a 7-year-old girl from Malawi.
Dr. Lin spent one year in the impoverished African country as a pediatric nutrition researcher, but what really struck her were the vast number of untreated orthopaedic problems she saw among the Malawians.
“I saw patients with broken legs or open fractures that were never treated, and so they had horrible deformities that prevented them from working in the fields or carrying things. In a place where your life depends on being able to work and walk for miles, these disabilities are not only hard on the patient but can affect the whole family’s survival. ” Dr. Lin recalled.
Now a clinician researcher at Cedars-Sinai Orthopaedic Center, Dr. Lin still remembers that 7-year-old, who likely suffered a septic knee in infancy and, as a result, had a 90 degree flexion contracture. The girl’s mother had to carry her everywhere, and believed her daughter would be crippled for life.
Dr. Lin, a 2012 OREF/Zimmer Young Investigator Grant recipient, was able to bring the girl and her mother to a British-run hospital. Curious, Dr. Lin viewed the girl’s X-rays and listened to surgeons develop a plan for her treatment.
“They performed three or four surgeries and by the end of it she had a straight leg and was able to walk. She went from someone who was completely disabled to having a much more functional life. And it was because of orthopaedic surgery,” Dr. Lin said. “I thought, ‘That’s pretty cool.’”
Thinking outside traditional research
Her experience in Malawi exposed Dr. Lin not only to the dramatically beneficial outcomes that orthopaedic surgery can provide, but also to the more general benefits of clinical research. Becoming a clinician scientist appealed to her interest in directly treating patients who sustain trauma as well as to her desire to investigate ways to improve patient outcomes more broadly.
In particular, Dr. Lin wanted to explore whether any information could be gleaned from patients who were not included in research studies but were being treated at the same centers that were involved in multi-center studies. With the OREF/Zimmer grant, Dr. Lin compared patients who participated in the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT), with those who were not enrolled.
SPRINT was a randomized controlled trial at centers worldwide, which looked at the effect of reaming on tibial shaft fractures. Tibia fractures are the most common long-bone fracture and the rates of nonunion necessitating reoperation are a challenge. The SPRINT trial found rates of reoperation lower than previously described, which may be explained by the strict inclusion criteria and adherence to study protocol. As part of the protocol, surgeons were prohibited from reoperating for nonunion before six months.
Thanks to the OREF/Zimmer funding, Dr. Lin was able to involve six of the 27 SPRINT centers, comparing 300 patients enrolled in the study to about 130 patients at the same centers who were eligible to participate but chose not to enroll.
Although the numbers were too small to reach statistical significance, Dr. Lin did discover some useful steppingstones for future research. Although un-enrolled patients were slightly more likely to undergo reoperation before the six months, both groups had much lower reoperation rates than what had been previously reported, which suggests that a center’s involvement in a study could impact the treatment of patients who were not enrolled.
Dr. Lin said her research found that there is much to be learned from studying observational cohorts. Following patients who do not enroll in trials can strengthen the overall research by adding new or previously unexplored information.
“There are a lot of questions that have answers based on history or tradition. We assume that’s the right thing to do, but we don’t necessarily have robust evidence to support that,” Dr. Lin said. Grants such as the OREF/Zimmer funding “really allow you to be critical of your own process and add something to the body of knowledge.”
Support to answer the hardest questions
Dr. Lin noted a growing interest—by patients and orthopaedic surgeons—toward functional outcomes. In some cases, that means focusing less on how well bones heal and more on whether the patient can drive a car or play with the grandchildren. But such a shift must be supported by solid research, she said.
“Orthopaedics has lagged behind other specialties in terms of the quality and quantity of research we’re able to produce,” she said. “The federal government, and large health care organizations are putting the onus on us to produce the research and evidence to justify our interventions and the costs to taxpayers and society.”
Dr. Lin said this is why OREF is vital to the continued advancement of orthopaedic surgery. OREF provides support to clinician researchers at all career levels, she said, from residents to established investigators, allowing them all the freedom to explore their most creative ideas.
“Most of the time when people have a question, if they don’t have an easy answer, they say, ‘Well, that’s an interesting question’ but then they move on. I think those questions—that aren’t easily answered—are the ones we should try to answer,” Dr. Lin said. “I think OREF’s greatest strength is that they give people the chance to pursue those questions.”