Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study

Abstract

BackgroundBenign primary bone tumors are commonly treated by surgery involving bone grafts or synthetic bone void fillers. Although synthetic bone grafts may provide early mechanical support while minimizing the risk of donor-site morbidity and disease transmission, difficult handling properties and less than optimal transformation to bone have limited their use.MethodsIn a prospective series, patients with benign bone tumors were treated by minimal invasive intervention with a bi-phasic and injectable ceramic bone substitute (CERAMENT™ BONE VOID FILLER, BoneSupport, Sweden) with the hypothesis that open surgery with bone grafting might be avoided. The defects were treated by either mini-invasive surgery (solid tumors) or percutaneous injection (cysts) and followed clinically and radiologically for 12 months. CT scan was performed after 12 months to confirm bone remodeling of the bone substitute. All patients were allowed full weight bearing immediately after surgery.ResultsFourteen patients with a median age of 13 years (range 7–75) were consecutively recruited during 11 months. Eleven lesions were bone cysts (eight unicameral and three post-traumatic) and three were solid benign tumors. The median size of the lesions was 40 mL (range 1–152). The most common location was humerus (n = 10). After 12 months the defects completely or partially filled with median 18 mL (range 5–28) of bone substitute demonstrated full resolution (Neer Classification grade I) in 11 patients, partial resolution (Neer II) in 2 patients and in 1 patient the cyst persisted (Neer III).No lesions required recurrent surgery during the observation period. No post-operative fracture or infection was recorded.ConclusionsMinimal invasive treatment with a bi-phasic and injectable ceramic bone substitute might offer an alternative to regular bone grafting due to convenient handling properties and rapid bone remodeling.Trial RegistrationClinicalTrials NCT02567084 Release Date 10/01/2015

Design and properties of a novel radiopaque injectable apatitic calcium phosphate cement, suitable for image‐guided implantation

“…Quantification was made at the wavelength of maximum absorption of iobitridol (k max 5 243 nm). A calibration curve in the 0-0.035 mg I mL 21 range was recorded prior to the experiments by dilution of a galenic Xenetix solution (350 mg I mL 21 iodine content) in pure water. Two columns were prepared under similar conditions, to ensure of the repeatability of the method.…”

“…The apatitic calcium phosphate cement (CPC) used in this study, abbreviated as MIADROS, was obtained from Graftys SA (Aix-en-Provence, France 21 ). Xenetix 350 was obtained from Guerbet (Villepinte, France) as 20 mL sealed glass vials with a 350 mg mL 21 iodine content.…”

“…The amount of radiopaque agent introduced in the CPC formulation was adjusted through partial replacement of the liquid phase (5 wt % Na 2 HPO 4 ) by the appropriate volume of sterile Xenetix 350, while keeping all other parameters fixed. After preparation of each dose of cement (6 g of powder 1 2.4 mL of liquid, leading to a cement paste containing 0, 37, 47, 56, or 70 mg I mL 21 , respectively), the resulting paste was immediately transferred into an injector (Somatex V R 4 mL-ref 180710) that was then connected to a trocart (Optimed V R 10 gauge, 0.7 mL-ref 1394-1010), before injection of the cement paste under fluoroscopy (Philips ALLURA FD20). The injections were performed under blind conditions (i.e., the two operators did not know the Xenetix content in the injected formulations), and for each vertebra, a rating of the radiopacity, injectability and texture of the CPC was given by the operating interventional radiologist, in comparison with standard PMMA used for vertebroplasty (see below).…”

“…Radiopacity Injectability Texture In accordance with local ethics and safety regulations, three female human cadavers with distinct body mass index (BMI) were selected for the second part or the experiment: specimen 1 (83 years old, average BMI % 23), specimen 2 (92 years old, high BMI % 30), and specimen 3 (84 years old, low BMI % 18). A strictly similar protocol was used by the same two operators, assisted by a fellow in interventional radiology as third operator, for the image-guided injection of the CPC (one unique loading of radiopaque agent, corresponding to a cement paste containing 56 mg I mL 21 ), except that a less performing fluoroscope was employed (STENOSCOP2 General Electric CGR).…”

“…At the same time, a sharp decrease of the dielectric losses (E 00 ) takes place as a result of the precipitation of CDA crystals in the intergranular space as well as on the surface of a-TCP particles. For increasing amounts of Xenetix in the CPC composition up to 70 mg I mL 21 , experimental data (see Figure S1 in Supporting Information) show that evolution of the E 0 and E 00 parameters has already started (i.e., 6 min are necessary to prepare the cement paste and load it in the dielectric cell before recording the first measurable dielectric values). In addition, the radiopaque agent does not inhibit or delay the setting reaction.…”