Abstract

Background and objectives: Patients suffering from bone metastasis are at high risk for pathological fractures and especially hip fractures. Osteolytic metastases can induce a high morbidity rate (i.e., pain, facture risk, mobility impairment), and operation on them can be difficult in this frail population having a reduced life expectancy. Several medical devices have been investigated for the prevention of these pathological hip fractures. Materials and Methods: To investigate these solutions, a literature review and a meta-analysis of primary studies was performed. Data sources included electronic databases (PubMed, CENTRAL and ClinicalTrials.gov) from 1990 until 1 January 2019. Titles, abstracts and full-text articles were reviewed in order to select only studies evaluating the performance of the studied solution to prevent osteoporotic and/or pathological hip fracture. The main outcomes were the occurrence of hip fracture, pain evaluation (VAS score) and adverse events occurrence (including severe adverse events and deaths). All randomised controlled trials (RCTs) and cohort studies were considered. A Bayesian cumulative meta-analysis was undertaken on the primary studies conducted in patients with bone metastasis. Results: A total of 12 primary studies were identified, all were cohort studies without a control group, and one compared two devices, and were thereafter considered separately. In those 12 samples, 255 patients were included, mean age 61.7 years. After implantation, the cumulative risk of fracture was 5.5% (95% confidence interval, 3.0% to 8.6%), and adverse event occurrence was 17.4% (95%CI, 12.6 to 22.8%), with a median follow-up of 10 months. The posterior probability of a fracture rate below 5% was 40.3%. Conclusions: The literature about medical devices evaluation for preventing hip fractures in metastatic patients is poor and mostly based on studies with a limited level of evidence. However, this systematic review shows promising results in terms of efficacy and tolerance of these devices in patients with bone metastases. This treatment strategy requires further investigations.

Highlights

  • Bone is the third location of metastases after lungs and liver

  • Medicina 2019, 55, 755 metastases can induce a high morbidity rate due to abnormal bone resorption [6], and operation on them can be difficult in this frail population having a reduced life expectancy [7]

  • A total of 12 articles were included in this review, representing 255 patients, of whom 234 were implanted with a surgical medical device, and 21 had no device implanted

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Summary

Introduction

Bone is the third location of metastases after lungs and liver. Bone metastasis, further to a cancer (in particular breast, kidney, lung, prostate or thyroid [1,2,3]), are frequently located in the proximal part of the femur [4] and in the femoral neck [5], highly exposed to fractures. Medicina 2019, 55, 755 metastases can induce a high morbidity rate due to abnormal bone resorption (i.e., pain, facture risk, mobility impairment) [6], and operation on them can be difficult in this frail population having a reduced life expectancy [7]. In these cancer patients, to prevent the occurrence of a pathological fracture of the proximal femur, surgical stabilization by femoroplasty or osteosynthesis is the first-line treatment, but only when patients can tolerate it, as it is associated with non-negligible surgical morbidity and mortality. In those 12 samples, 255 patients were included, mean age

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