Security and reliability of CUSTOMBONE cranioplasties: A prospective multicentric study.

BACKGROUND: Repairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted with complications such as infections, breaches, displacements and rejections leading to failure and thus explantation of the prosthesis. OBJECTIVE: To evaluate cumulative explantation and infection rates following the implantation of a tailored cranioplasty CUSTOMBONE prosthesis made of porous hydroxyapatite. One hundred and ten consecutive patients requiring cranial reconstruction for a bone defect were prospectively included in a multicenter study constituted of 21 centres between December 2012 and July 2014. Follow-up lasted 2 years. RESULTS: Mean age of patients included in the study was 42±15 years old (y.o), composed mainly by men (57.27%). Explantations of the CUSTOMBONE prosthesis were performed in 13/110 (11.8%) patients, significantly due to infections: 9/13 (69.2%) (p<0.0001), with 2 (15.4%) implant fracture, 1 (7.7%) skin defect and 1 (7.7%) following the mobilization of the implant. Cumulative explantation rates were successively 4.6% (SD 2.0), 7.4% (SD 2.5), 9.4% (SD 2.8) and 11.8% (SD 2.9%) at 2, 6, 12 and 24 months. Infections were identified in 16/110 (14.5%): 8/16 (50%) superficial and 8/16 (50%) deep. None of the following elements, whether demographic characteristics, indications, size, location of the implant, redo surgery, co-morbidities or medical history, were statistically identified as risk factors for prosthesis explantation or infection. CONCLUSION: Our study provides relevant clinical evidence on the performance and safety of CUSTOMBONE prosthesis in cranial procedures. Complications that are difficulty incompressible mainly occur during the first 6 months, but can appear at a later stage (>1 year). Thus assiduous, regular and long-term surveillances are necessary.

Surgical preference regarding different materials for custom-made allograft cranioplasty in patients with calvarial defects: Results from an internal audit covering the last 20 years.

BACKGROUND: Secondary cranioplasty (CP) plays a key role in restoring cranial vault anatomy and normal brain function following decompressive craniectomy (DC). The scientific literature provides only fragmentary information regarding the best timing and material for CP, making a direct comparison of different materials difficult. OBJECT: To identify and report according to STROBE guidelines local trends in choice of materials for CP, complications rate and surgical outcomes. METHODS: We conducted an audit on secondary CP covering the last 20 years of surgical practice at our Institution. Custom-made CP used over the years were made of: porous hydroxyapatite (PHA), polymetylmethacrylate (PMMA), polyetheretherketone (PEEK), acrylic and titanium. The primary endpoint of this study was the incidence of postoperative complications, such as: implant infection, fracture and dislocation. Secondary endpoints were the followings: patients satisfaction with cosmetic result, rate of implant integration, and long-term neurological outcome. RESULTS: A total of 218 patients were included, given the predominance of PHA (Group A) or PMMA (Group B) CP, a direct comparison was made only between those two groups. Overall reoperation rate was 6.5% versus 28%; implants' osseointegration rate was of 69% versus 24%; satisfaction rate was 66% versus 44%, in Group A and B respectively. CONCLUSIONS: This single-centre study provides Level 3 evidence that PHA yields better outcomes than PMMA CP. Designing a management algorithm for planning and executing CP is difficult for clinical and organizational reasons; till a widespread consensus is reached, neurosurgeons with subspecialty interest in neurotrauma should favor pragmatism and patient safety over costs.

Mid-term progressive loosening of hydroxyapatite-coated femoral stems paired with a metal-on-metal bearing.

BACKGROUND: Several hydroxyapatite (HA)-coated femoral stems from a single manufacturer were identified to have aseptically loosened at mid-term follow-up despite prior radiographic appearance of osseointegration. Possible causes and associated risk factors for stem loosening were explored through radiographic review and implant retrieval analysis. METHODS: Forty-six retrieved hip stems (Corail, DePuy-Synthes) were identified and grouped by bearing type: metal-on-metal (MoM), metal-on-polyethylene, and ceramic-on-ceramic. Stem lucency was graded on post-operative radiographs up to the time of revision. Stems were examined for stripping of the HA coating, taper corrosion, and bearing wear in metal-on-metal cases. Patient demographics, implant design features, and perioperative data were collected from electronic databases and patient charts. RESULTS: Aseptic loosening occurred in 37% of cases examined. MoM bearings were associated with 7.25 times greater risk of loosening compared to other bearing types. Stem radiolucency was more prevalent for MoM cases and, although not statistically significant, demonstrated progressive lucency. Taper corrosion appeared more severe for MoM cases and correlated with proximal stem radiolucency. Removal of the HA coating from the stems was associated with both taper corrosion and MoM bearing wear. Length of implantation was a confounding factor for the MoM cases. CONCLUSION: This study has demonstrated a high risk of mid-term loosening of previously osseointegrated HA-coated femoral stems when paired with a MoM bearing. The mechanism of loosening appears progressive in nature and related to the MoM bearing, possibly interacting with the HA coating. If such loosening is recognized early, rapid revision may allow for retention of the femoral stem.

Hydroxyapatite dip coated and uncoated titanium poly-axial pedicle screws: an in vivo bovine model.

STUDY DESIGN: A 1-year-old calf was implanted with titanium pedicle screws either uncoated (n = 7) or coated with hydroxyapatite (n = 7) by the dipping method on the pedicles of vertebrae (t10-l3). OBJECTIVE: To evaluate biomechanical and histomorphologic responses to titanium pedicle screws uncoated and coated with hydroxyapatite. SUMMARY OF BACKGROUND DATA: Failure of fixation caused by loosening of pedicle screws is a problem in spinal surgery. Enhancement of the fixation ability of screws by coating with biocompatible materials may improve prognosis of surgery. METHODS: The calf was euthanized 4 months after implantation for determination of insertion and extraction torques for screws, and histologic and scanning electron microscopic examinations of areas screw embedded. RESULTS: Insertion torques did not differ by the kind of screws (99 +/- 5.7 Ncm). However, extraction torques for screws coated with hydroxyapatite were higher than for screws uncoated (249 vs. 133 Ncm, P < 0.01). As compared with uncoated screws, implanted areas for hydroxyapatite-coated screws were denser, had more cracks, and provided better bonding. Fibrous tissue and new bone formation were observed around the areas of uncoated and hydroxyapatite-coated screws embedded, respectively. CONCLUSIONS: Hydroxyapatite coating of titanium pedicle screws by the dipping method improved fixation and vertebral bone-implant interface, suggesting a decreased risk of a screw-loosening problem.

[Experimental study of the biocompatible and osteoinductive behavior of the hydroxyapatite/ultra-high molecular weight polyethtlene composite].

OBJECTIVE: To compare the biocompatibility and osteoinductive behavior of HA (hydroxyapatite) and HA/UHMWPE (ultra-high molecular weight polyethtlene) composite in orbital implantation. METHODS: Osteoectomy of the upper orbital rim was perform on 24 adult New Zealand rabbits. The animals were randomly divided into 4 groups with 6 of each. The HA, HA/UHMWPE composite or UHMWPE (10 mm x 10 mm x 3 mm in size) was implanted to the upper orbital defect of the animal in respective group. Animals were sacrificed at 1, 4, 8, 12 weeks. Histopathologic sections of the implants were evaluated and compared with light and transmission electron microscopy study. RESULTS: During the experimental period of 12 weeks, there was no implant extrusion or displacement. In the groups of HA and HA/UHMWPE composite, vascular ingrowth and fibroblasts were observed shortly and osteocytes were seen at 8 weeks. Calcium deposition of the implants showed a laminar fashion at 12 weeks. In the group of UHMWPE, fibrous membranes were seen around the implant at 1 week. Transmission electron microscopy study showed that in the HA and HA/UHMWPE groups, fibroblasts and vascular ingrowth could be seen, but osteocytes were not observed. CONCLUSION: HA/UHMWPE composite demonstrated biocompatibility and osteoinductive property. It would be a good substitute for bone, particularly for orbital bone.

Development of hybrid type artificial bone marrow using sintered hydroxyapatite.

In vivo inducement of hybrid-type artificial bone marrow with hemopoietic inductive microenvironment (HIM) in sintered hydroxyapatite (HA) chamber was carried out. This research is important to disclose the mechanisms of hemopoiesis and is useful for clinical application. In the evolution of vertebrates, cartilage of the inner skeleton changed into bone, having biomechanical properties to form bone marrow cavities. The hemopoietic nests immigrated into the cavities from the spleen. We should be able to induce hemopoietic nests in a hydroxyapatite chamber in place of bone, if we can find optimal structural conditions. Therefore, we tried to artificially induce a hematopoietic field in muscles using sintered porous tubular hydroxyapatite and new type hydroxyapatite plate made by high-pressure gas technique. As a result, not only in the pore sites of tubular hydroxyapatite artificial bone, but at the surface of the new type hydroxyapatite plate implanted in the dorsal muscles, marked differentiation of bone marrow cell clusters of the hematopoietic field could be observed.

Synthesis of bioactive coatings on Ti substrates using glass enamel.

Bioactive coatings on titanium can be prepared by dispersing hydroxyapatite particles into a borosilicate glass enamel doped with TiO2. Adhesion of the coating is obtained when the titanium substrate has been preoxidized before enameling in such a way as to form a continuous TiO2-layer. Adhesion results from the diffusion of this TiO2-layer into the liquid glass during enameling. The evolution of the diffusion zone was followed by scanning electron microscopy and electron probe microanalysis. Adhesion disappears after a critical time of firing which corresponds to the completion of the dissolution of the TiO2-layer by the glass. The borosilicate glass wets the hydroxyapatite particles and adheres strongly to them after cooling.