• Cardiovasc Intervent Radiol · Jul 2017

    Multicenter Study

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

    • François H Cornelis, Lambros Tselikas, Thibault Carteret, Bruno Lapuyade, Thierry De Baere, Vincent Cabane, Laëtitia Rodrigues, Charlène Maas, and Frédéric Deschamps.
    • Pellegrin Hospital, CHU Bordeaux, Bordeaux, France. cornelisfrancois@gmail.com.
    • Cardiovasc Intervent Radiol. 2017 Jul 1; 40 (7): 1070-1076.

    ObjectivesTo prospectively evaluate a novel implant, Y-STRUT® (Hyprevention, Pessac, France), designed to provide prophylactic reinforcement of the proximal femur in metastatic patients.MethodsTen 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.ResultsAll 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.ConclusionsResults 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 EvidenceLevel 4, Case Series.

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