BALTIMORE — The use of long-stem hemiarthroplasty (LSHA) did not improve quality-of-life (QoL) or functional outcomes compared to intramedullary nailing (IMN) in treating pathological fractures of the pertrochanteric femur caused by bone metastases, a researcher reported.
In the randomized controlled surgical trial, short-term outcomes (3 to 12 months) demonstrated that mean Toronto Extremity Salvage Scores (TESS) values were no better for LSHA patients than for IMN patients, reported John Healey, MD, of Memorial Sloan Kettering Cancer Center in New York City, at the the hybrid Musculoskeletal Tumor Society (MSTS) annual meeting, held virtually and in-person.
The same held true for outcomes related to pain and physical function, according to Healey’s group.
Osteoporosis and bone fragility, particularly fractures in the elderly and those cause by cancer, are among the orthopedic conditions with the greatest burden of disease. Healey noted that proximal femur pathological fracture was identified as the top orthopedic oncology priority at a 2009 meeting of the American Academy of Orthopaedic Surgeons, Orthopaedic Research Society, and the NIH.
While there are a variety of techniques available to treat pathological fractures of the pertrochanteric femur, a survey of MSTS members, conducted 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 to LSHA. However, research has also demonstrated that endoprostheses are more durable than intramedullary devices in the treatment of proximal femur metastases.
Healey pointed out there is no consensus about whether IMN or LSHA has better outcomes in the short term, or provides better function.
This study was conducted at six centers, and was designed to compare outcomes between IMN and LSHA. Eligible patients had metastatic pertrochanteric impending or completed fractures for which the surgeon had equipoise (meaning they had genuine uncertainty regarding which was the most beneficial treatment).
For the trial, 71 patients (median age 64.4) were randomized and treated; 38 to IMN and 33 to LSHA. The majority of patients (55%) were female, and 70% had primary tumors from the breast, lung, prostate, or kidney.
The primary outcome was QoL as measured by TESS, while secondary outcomes were pain on a visual analog scale (VAS) and timed get-up-and-go (TGUG).
Healey reported that mortality at 3 months exceeded projections for both IMN (10 of 38 patients) and LSHA (six of 33 patients). These deaths — along with disease progression at 12 weeks, trial withdrawal, losses to follow-up, and missing 12-week TESS scores — left 19 evaluable patients in each study arm.
Healy and colleagues also found:
- TESS values decreased in seven IMN patients by 3-40 points and in three LSHA patients by 1-18 points.
- In an intention-to-treat analysis, mean TESS values at 3 months were no better for LSHA patients (63.9) than for IMN patients (56).
- After 1 year, TESS values among the patients still alive were similar between those treated by LSHA (64.7) and those treated by IMN (62.2).
- There were no differences in TGUG or VAS pain scores at any time point.
“It is very difficult to do multi-institutional randomized surgical trials,” Healy said, noting that patient accrual and follow-up were slow despite the multi-institutional design of the study. Factors that inhibited enrollment included concomitant hip arthritis, other lesions throughout the femur, language barriers, and the lack of surgeon equipoise.
Healey’s group also observed that excess mortality rates, COVID-19 restrictions, and rapid disease progression that prohibited follow-up also meant that data were missing in the trial’s early and late stages. Finally, he noted that investigators were prevented from recruiting patients from three collaborating European center due to E.U General Data Protection Regulations.
As for which of the two techniques should be used, orthopedic surgeons “will have to make your own decisions,” Healey said, “But, the durability of long-stem hemiarthroplasty continues to support my advocacy for it.”
Mike Bassett is a staff writer focusing on oncology and hematology. He is based in Massachusetts.
The study was funded by the Orthopaedic Research and Education Foundation and the National Cancer Institute.
Healey disclosed no relationships with industry.