title: A Novel Implant for the Prophylactic Treatment of Impending Pathological Fractures of the Proximal Femur: Results from a Prospective, First-in-Man Study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Level 4, Case Series.
authors.affiliation: Pellegrin Hospital, CHU Bordeaux, Bordeaux, France. cornelisfrancois@gmail.com.
authors.forename: François H
authors.initials: FH
authors.lastname: Cornelis
authors.affiliation: Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.
authors.forename: Lambros
authors.initials: L
authors.lastname: Tselikas
authors.affiliation: Saint Andre Hospital, CHU Bordeaux, Bordeaux, France.
authors.forename: Thibault
authors.initials: T
authors.lastname: Carteret
authors.affiliation: Haut-Leveque Hospital, CHU Bordeaux, Bordeaux, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Lapuyade
authors.affiliation: Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: De Baere
authors.affiliation: Hyprevention, Clinical Research, Pessac, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Cabane
authors.affiliation: Hyprevention, Clinical Research, Pessac, France.
authors.forename: Laëtitia
authors.initials: L
authors.lastname: Rodrigues
authors.affiliation: Hyprevention, Clinical Research, Pessac, France.
authors.forename: Charlène
authors.initials: C
authors.lastname: Maas
authors.affiliation: Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Deschamps
mesh_terms: D000368:Aged; D001577:Benzophenones; D005240:Feasibility Studies; D005260:Female; D005266:Femoral Neoplasms / Q000556:secondary* / Q000601:surgery*; D005593:Fracture Fixation, Internal / Q000295:instrumentation* / Q000379:methods*; D005598:Fractures, Spontaneous / Q000517:prevention & control* / Q000601:surgery*; D005602:France; D006620:Hip Fractures / Q000517:prevention & control* / Q000601:surgery*; D006801:Humans; D007659:Ketones; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011092:Polyethylene Glycols; D011108:Polymers; D011446:Prospective Studies; D019736:Prostheses and Implants; D025321:Surgery, Computer-Assisted; D055815:Young Adult
chemical_list: D001577:Benzophenones; D007659:Ketones; D011108:Polymers; C063834:polyetheretherketone; D011092:Polyethylene Glycols
keywords: Bone metastasis; Implants; Osteosynthesis; Preventive therapy