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

  • Clinical Investigation
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

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.

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Acknowledgements

None.

Funding

This study was funded by Hyprevention, Pessac, France.

Author information

Authors and Affiliations

  1. Pellegrin Hospital, CHU Bordeaux, Bordeaux, France

    François H. Cornelis

  2. Gustave Roussy Cancer Campus Grand Paris, Villejuif, France

    Lambros Tselikas, Thierry De Baere & Frédéric Deschamps

  3. Saint Andre Hospital, CHU Bordeaux, Bordeaux, France

    Thibault Carteret

  4. Haut-Leveque Hospital, CHU Bordeaux, Bordeaux, France

    Bruno Lapuyade

  5. Hyprevention, Clinical Research, Pessac, France

    Vincent Cabane, Laëtitia Rodrigues & Charlène Maas

Authors
  1. François H. Cornelis
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  2. Lambros Tselikas
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  3. Thibault Carteret
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  4. Bruno Lapuyade
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  5. Thierry De Baere
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  6. Vincent Cabane
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  7. Laëtitia Rodrigues
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  8. Charlène Maas
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  9. Frédéric Deschamps
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Corresponding author

Correspondence to François H. Cornelis.

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Conflict of interest

Laëtitia Rodrigues and Charlène Maas are employees of Hyprevention, Pessac, France. Vincent Cabane (Tree House Consulting, Paris, France) is a consultant for Hyprevention, Pessac, France. François Cornelis and Frédéric Deschamps are members of the scientific board of Hyprevention, Pessac, France. Thibault Carteret, Thierry De Baere, Bruno Lapuyade and Lambros Tselikas declare that they have no conflict of interest.

Human and Animal Rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Cornelis, F.H., Tselikas, L., Carteret, T. et al. A Novel Implant for the Prophylactic Treatment of Impending Pathological Fractures of the Proximal Femur: Results from a Prospective, First-in-Man Study. Cardiovasc Intervent Radiol 40, 1070–1076 (2017). https://doi.org/10.1007/s00270-017-1613-5

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  • DOI: https://doi.org/10.1007/s00270-017-1613-5

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