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Erschienen in:
23.02.2017 | Clinical Investigation
A Novel Implant for the Prophylactic Treatment of Impending Pathological Fractures of the Proximal Femur: Results from a Prospective, First-in-Man Study
Erschienen in: CardioVascular and Interventional Radiology | Ausgabe 7/2017
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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.