Hip Fracture Prevention in Osteoporotic Elderly and Cancer Patients: An On-Line French Survey Evaluating Current Needs.

Background and objectives: Hip fracture is a major public health issue. Those fractures lead to high costs and a decrease in quality of life. A national French survey was conducted, with the objectives to firstly assess the current management of hip fracture and its prevention, both in the osteoporotic and cancer settings, and secondly to evaluate the opinions of physicians on the potential use of minimally invasive implantable devices to prevent hip fracture in alternative of surgery. Materials and methods: This national survey was conducted in France between April and July 2017. Questionnaires were sent to orthopedic surgeons, interventional radiologists, oncologists, and rheumatologists. Completed questionnaires were analyzed and compared according to two indications: orthopedics-traumatology and oncology. Factors associated with these responses were assessed using univariable analyses, based on chi-square tests or an exact Fisher test, as appropriate. Results: A total of 182 questionnaires were completed and further analyzed. Physicians have highlighted the need for a low re-fracture rate and to improve life expectancy for more than 1 year (50% for responders of the orthopedics-traumatology questionnaire and 80% for the responders interested in both indications), as well as quality of life (12.5% and 31%, respectively), but with no significant differences in the oncologic indication. Most of the experts were willing to use or prescribe implantable devices for prevention (63% in orthopedics-traumatology and 93% in oncology), although limited clinical experience (54 and 58%) and surgical risk (around 30% in each indication) were considered as limits. Conclusions: Prevention of hip fracture remains a concern for physicians. More clinical experience with implantable devices, in particular in cancer patients, is needed, but implemented in a strategy to maximize patient recovery while reducing costs.

Prevention of Pathological Fracture of the Proximal Femur: A Systematic Review of Surgical and Percutaneous Image-Guided Techniques Used in Interventional Oncology.

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.

A Novel Implant for the Prophylactic Treatment of Impending Pathological Fractures of the Proximal Femur: Results from a Prospective, First-in-Man Study.

OBJECTIVES: To prospectively evaluate a novel implant, Y-STRUT® (Hyprevention, Pessac, France), designed to provide prophylactic reinforcement of the proximal femur in metastatic patients. METHODS: Ten patients presenting lytic lesions of the proximal femur were to be treated. The device consisted of two components implanted in the proximal femur, combined with bone cement. Patients were followed at 2, 6 and 12 months to record technical feasibility, safety and efficacy parameters of the procedure. RESULTS: All patients (62 years, 67% male) presented a pertrochanteric lesion shown on imaging with an average Mirels' score of 9.42 (range 8-11). Procedures were performed by interventional radiologists, under general anesthesia in 97 ± 28 min, with 9.2 ± 3.1 ml of cement injected. Hospitalization duration was 2.3 ± 1.4 days. A median follow-up of 237 days (range 24-411) was reported. Wound healing was achieved in all patients, with no case of wound infection, bleeding, leakage or inflammation. Among the patients evaluated, 86% could resume walking at hospital discharge. Visual Analogue Scale decreased from 3.6 ± 2.9 before treatment to 1.3 ± 0.8 at 1 year. OHS-12 score increased from 30 ± 10 at baseline to 37 ± 6 at 1 year. CONCLUSIONS: Results from this first-in-man study conducted in patients with metastatic bone disease show the feasibility and the safety of the intervention, with a short hospitalization, when performed following the operating instructions. Initial data showing pain-level diminution and increase in OHS-12 score indicate that both symptomatic and functional conditions of the patients were improved 1 year after the implantation of this novel implant. LEVEL OF EVIDENCE: Level 4, Case Series.