BALTIMORE – The use of long stem hemiarthroplasty (LSHA) did not improve quality of life (QoL) or functional outcome compared to intramedullary nailing (IMN) in the treatment of pathologic fractures of the pertrochanteric femur caused by bone metastases, one researcher reported.
In the randomized controlled surgical trial, short-term results (3 to 12 months) demonstrated that the mean Toronto Extremity Recovery Scores (TESS) were no better for LSHA patients than for IMN patients, reported John Healey, MD , from Memorial Sloan Kettering Cancer Center in New York City, at the Hybrid Musculoskeletal Tumor Society (MSTS) Annual Meeting, held virtually and in person.
The same goes for results related to pain and physical function, according to Healey’s group.
Osteoporosis and bone fragility, particularly fractures in the elderly and those caused by cancer, are among the most morbid orthopedic conditions. Healey noted that pathologic fracture of the proximal femur was identified as the top priority in orthopedic oncology at a 2009 meeting of the American Academy of Orthopedic Surgeons, the Orthopedic Research Society, and the NIH.
Although there are a variety of techniques available to treat pathologic fractures of the pertrochanteric femur, a survey Members of MSTS, led by Healey and co-author Matthew Steensma, MD, of SHMG Orthopedic Oncology / Lemmen Holton Cancer Pavilion in Grand Rapids, Michigan, found that there was a preference for IMN over LSHA. However, research has also shown that stents are more durable than intramedullary devices in the treatment of proximal femoral metastases.
Healey pointed out that there is no consensus as to whether IMN or LSHA has better short-term results, or provides better function.
This study was conducted in six centers and was designed to compare the results between IMN and LSHA. Eligible patients had impending or completed pertrochanteric metastatic fractures for which the surgeon was in balance (meaning they had real uncertainty as to which treatment was most beneficial).
For the trial, 71 patients (median age 64.4 years) were randomized and treated; 38 to IMN and 33 to LSHA. The majority of patients (55%) were women and 70% had primary tumors of the breast, lung, prostate or kidney.
The primary outcome was quality of life as measured by TESS, while the secondary outcomes were pain on a visual analogue scale (VAS) and time to get up and to go (TGUG).
Healey reported that 3-month mortality exceeded projections for both IMN (10 of 38 patients) and LSHA (six of 33 patients). These deaths – along with disease progression at 12 weeks, withdrawal from the trial, loss of follow-up, and missing TESS scores at 12 weeks – left 19 evaluable patients in each study arm.
Healy and her colleagues also found:
- TESS values decreased by 3 to 40 points in seven IMN patients and by 1 to 18 points in three LSHA patients.
- In an intention-to-treat analysis, mean 3-month TESS values were not better for LSHA patients (63.9) than for IMN patients (56).
- After 1 year, TESS values among patients still alive were similar between those treated with LSHA (64.7) and those treated with IMN (62.2).
- There was no difference in TGUG or VAS pain scores at any time.
“It’s very difficult to do multi-institutional randomized surgical trials,” Healy said, noting that patient accumulation and follow-up was slow despite the study’s multi-institutional design. Factors that inhibited recruitment included concomitant hip arthritis, other lesions throughout the femur, language barriers, and the surgeon’s unsteadiness.
Healey’s group also observed that excess mortality rates, COVID-19 restrictions and rapid disease progression that precluded follow-up also meant data was missing in the early and late stages of the trial. Finally, he noted that investigators were prevented from recruiting patients in three European collaborating centers due to the EU General Data Protection Regulation.
As to which of the two techniques should be used, orthopedic surgeons “will have to make their own decisions,” Healey said. “But, the durability of long stem hemiarthroplasty continues to support my advocacy for this one.”
The study was funded by the Foundation for Orthopedic Research and Education and the National Cancer Institute.
Healey did not disclose any relationship with the industry.