Cemented long versus standard femoral stem in proximal femoral metastasis: a noninferiority single-blinded quasi-randomized clinical trial

Abstract

Background and purpose : Proximal femur is a common site for metastasis, it has a significant impact on patient’s quality of life, and traditional treatment aims at protecting as much as possible from the femur. However, recent studies have demonstrated increased rate of complications and questioned the need for long stem in this high-risk group. Our purpose is to determine whether standard-length femoral stem is non-inferior to long femoral stem in the treatment of proximal femoral metastasis. Patients and methods: Between 2019 and 2021, we prospectively included 24 patients with proximal femoral metastasis leading either to impending or pathological fractures (5 and 19 cases, respectively). We included patients with lesions due to metastasis, lymphoma, or multiple myeloma. Patients were quasi-randomized based on their order of presentation into two groups based on the femoral stem length, cemented standard (group 1) and long (group 2) femoral stem. Oncological complications, survival, stem complications, and functional outcomes were recorded and analyzed using SPSS 25. Results: 24 patients were included in the final analysis, 13 case in group 1 and 11 in group 2, and mean age 57.6 years. Mean follow-up duration was 10 months, and 11 patients died of the whole-study population with mean survival of (10.85 ± 2.23, 8.82 ± 3.6) months in group 1, 2, respectively. The complication rate was higher in the standard group; however, this difference did not reach statistical significance. No difference was found between study groups regarding functional outcomes, except for VAS at 6 months which was higher in standard group. Conclusion: We believe that the ubiquitous use of long stem in the management of proximal femoral metastasis should be questioned considering the expected patient survival and low rate of complications associated with the use of standard stem. Clinicaltrials.gov registration number : NCT04660591.