NEW YORK (Reuters Health) – Patients who undergo cemented hemiarthroplasty report a slightly better quality of life four months after surgery and have a periprosthetic fracture rate that is four times lower than people whose fractures are repaired using modern uncemented devices, according to results from a new study of 1,225 volunteers.
For patients, this is “very good news,” Dr. Matthew Costa of the University of Oxford, UK, who worked on the study, told Reuters Health by email.
“This trial provides the clearest evidence yet that cemented hemiarthroplasty provides patients with better quality of life than using a modern uncemented hemiarthroplasty,” he said. “There was also a lower risk of fracture around the implant if it was fixed with bone cement. This should improve the results of surgery for patients with this very serious injury.”
“Shifting to cemented procedures may force many clinicians out of their comfort zone,” Dr. Cecilia Rogmark of Lund University in Malmoe, Sweden, writes in an editorial in the New England Journal of Medicine, where the new study appears. “Yet the use of bone cement appears to be the best way to reinforce the health of our frail elderly patients with a femoral neck fracture.”
Dr. Costa, a professor of orthopedic trauma, was more optimistic. “Most surgeons are trained in the use of bone cement – it’s not a particularly difficult technique – so it shouldn’t be a major issue for surgeons to change to using a cemented hemiarthroplasty,” he said.
The use of bone cement has been associated with a rare syndrome where increased intramedullary pressure causes an embolism that can lead to a drop in blood pressure and, potentially, instances of neurophysiological problems, cardiovascular collapse and death.
“While the overall incidence of any signs of cement implantation syndrome may be around 1.7%, death is fortunately very rare indeed,” Dr. Costa said.
Nonetheless, doctors have been moving toward hydroxyapatite-coated uncemented implants “despite little evidence that they were better than cemented implants,” he explained.
The WHiTE 5 trial included 1,225 volunteers aged 60 and over, some of whom suffered from cognitive impairment. The patients and people involved in their follow-up or assessment were not aware of the group assignments.
The biggest complication that registered as a significant difference after 12 months of follow-up was periprosthetic fractures, seen in 0.5% in the cement group and 2.1% in the uncemented group, a significant difference.
“Other complications and revision surgery were uncommon and balanced between the trial groups,” the researchers report.
Mortality after one year was 23.9% with cement use versus 27.8% without, representing a 20% reduction in the odds of death for the cement group (odds ratio, 0.80; 95% CI, 0.62 to 1.05).
When the study team looked at quality of life scores, the cement group came out slightly ahead with a utility score of 0.371 versus 0.315 on the EuroQol Group 5-Dimension questionnaire (P=0.02). The minimal clinically important difference is estimated at 0.050 to 0.075.
That difference appeared four months after surgery. One month after the operation, both groups scored comparably in quality of life and at one year, the difference seen at four months had narrowed.
Among the patients who were living at home at the time of surgery, 70.1% in the cemented group and 69.8% in the uncemented group went back home after their hospitalization.
Dr. Rogmark cautions that “many orthopedic surgeons have not maintained clinical skills in cementing techniques. Short-sighted economic concerns may also have led to the avoidance of cement in order to shorten surgery time. However, the estimated difference of 7 minutes for cemented as compared with uncemented hemiarthroplasty is irrelevant when considering the entire cost of a hip fracture.”
Dr. Costa said using cement turns out to be cheaper than the uncemented option, but a full cost analysis is being reported separately.
“Consensus within the operating-room team on the overall positive risk-benefit ratio of cement, increased experience in invasive monitoring and active prevention of cardiorespiratory compromise, and better knowledge of cementing technique are all necessary to perform safe surgery with durable benefit,” Dr. Rogmark writes.
SOURCE: https://bit.ly/3rqrHWx and https://bit.ly/3L88MI1 The New England Journal of Medicine, online February 9, 2022.
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