乌鸦传媒

Patients who received intramedullary nails (IMNs) to repair trochanteric fractures reported no difference in health-related quality of life compared with those who received sliding hip screws (SHS), the clinical trial found.

At 1-year follow-up, patient-reported EuroQol-5 Dimension scores were similar between those treated with IMN versus SHS (mean difference 0.02 points, 95% CI -0.03 to 0.07 points, P=0.42), reported Emil Schemitsch, MD, of Western University in London, Canada, and co-authors.

After adjusting for relevant covariables, there were no significant between-group differences (regression coefficient 0.00, 95% CI -0.04 to 0.05, P=0.81).

"Although IMN fixation may offer some benefits surrounding earlier mobility over SHS fixation for certain subgroups of patients (i.e., those who are high-functioning with unstable fracture types), these data suggest this is not the case for most patients, and that the recent increase in more costly IMN fixation is unwarranted," Schemitsch and co-authors wrote in .

Trochanteric fractures are commonly treated with IMN fixation or extramedullary SHS. "Nails [IMN] are perceived to lead to earlier recovery and to have advantages with certain more unstable fracture patterns," Schemitsch told 乌鸦传媒 in an email. "A large prospective prognosis study would be helpful to learn what factors are most important for implant choice, particularly in those patients who are high functioning with unstable fracture patterns."

Despite the paucity of high-quality evidence supporting intramedullary over extramedullary fixation, the use of IMNs has been increasing internationally, the researchers noted. IMNs can cost up to 40% more than SHS, they pointed out.

While older meta-analyses have associated IMNs with higher complication risk, IMN design has improved, and some small single-center studies have found patients with IMN devices have reported better quality of life and functional scores. Still, most previous clinical trials comparing function at 1 year with both implants found no difference in functional outcomes at 1 year, Schemitsch and co-authors noted.

In an , Marc Swiontkowski, MD, and Mai Nguyen, MD, both of the University of Minnesota in Minneapolis, pointed to the "rapid rise" in IMN over SHS in clinical practice, with IMNs used 79% of the time in the U.S. "This begs the important question: What is the main driver behind surgeon implant choice?" they wrote.

The current American Academy of Orthopaedic Surgeons' Clinical Practice Guideline for recommends the use of either SHS or IMN for patients with stable intertrochanteric fractures with the highest strength of recommendation, they noted.

In the absence of obvious differences in clinical outcomes, the preference "is likely influenced by industrial promotion of newer implants and industry-sponsored education courses that are often attended by young surgeons and residents in training," the editorialists continued. "Even after the reimbursement equalized, we continue to observe the rise of IMN utilization in hip fracture management," they said.

Surveys have suggested surgeons might find IMN easier to use, but it's unclear whether that advantage alone balances out the cost, Swiontkowski and Nguyen added.

INSITE included 850 adult patients with low-energy trochanteric fractures, with 423 people randomized to IMN and 427 to SHS. Mean age was 78.5 and 64.6% were female.

The study period ran from 2012 to 2016, with assessments at 13, 26, and 52 weeks. A total of 221 patients were lost to follow-up at 1 year.

The primary outcome was health-related quality of life at 1-year postsurgery. Secondary outcomes included revision surgical procedures, fracture healing, adverse events, patient mobility (Parker mobility scores), and hip function (Harris hip scores).

Secondary endpoints showed similar between-group results. Revision surgery at 1 year totaled 15 IMN patients and 22 SHS patients (OR 0.68, 95% CI 0.25-1.32, P=0.25). In the IMN group, 23 had unhealed fractures at 12 weeks, compared with 35 patients in the SHS group (OR 0.61, 95% CI 0.35-1.08, P=0.09).

Parker mobility scores at 1 year did not show significant differences (mean difference 0.37 points, 95% CI -0.04 to 0.79, P=0.08), nor did Harris hip scores (mean difference 1.24 points, 95% CI -2.59 to 5.06, P=0.53). However, mobility scores were higher at 13 weeks and 26 weeks in the IMN group compared with the SHS group, though differences weren't clinically meaningful, the researchers noted.

No between-group difference in mortality (OR 0.97, 95% CI 0.66-1.42), or fracture-related adverse events at 1-year postsurgery (OR 0.85, 95% CI 0.50-1.42, P=0.53) emerged. Sensitivity analyses showed no significant interaction for fracture stability (P=0.82) or previous fracture (P=0.88) and treatment group.

Study limitations included the high proportion of patients lost to follow-up, which may be due to age and comorbidities, the researchers suggested. In addition, all patients in IMN group were treated with a Gamma3 nail, but those in the SHS group did not receive a standardized device.

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