Novel bone-anchored vascular access on the mastoid for hemodialysis: concept and preclinical trials

GOAL We present the development of a boneanchored port for the painless long-term hemodialytic treatment of patients with renal failure. This port is implanted behind the ear. METHODS The port was developed based on knowledge obtained from long-term experience with implantable hearing devices, which are firmly anchored to the bone behind the ear. This concept of bone anchoring was adapted to the requirements for a vascular access during hemodialysis. The investigational device is comprised of a base plate that is firmly fixed with bone screws to the bone behind the ear (temporal bone). A catheter leads from the base plate valve block through the internal jugular vein and into the right atrium. The valves are opened using a special disposable adapter, without any need to puncture the blood vessels. Between hemodialysis sessions the port is protected with a disposable cover. RESULTS Flow rate, leak tightness and purification were tested on mockups. Preoperative planning and the surgical procedure were verified in 15 anatomical human whole head specimens. CONCLUSION Preclinical evaluations demonstrated the technical feasibility and safety of the investigational device. SIGNIFICANCE Approximately 1.5 million people are treated with hemodialysis worldwide, and 25% of the overall cost of dialysis therapy results from vascular access problems. New approaches towards enhancing vascular access could potentially reduce the costs and complications of hemodialytic therapy.

Effect of an intervertebral disk spacer on stiffness after monocortical screw/polymethylmethacrylate fixation in simulated and cadaveric canine cervical vertebral columns.

OBJECTIVE To determine the biomechanical effect of an intervertebral spacer on construct stiffness in a PVC model and cadaveric canine cervical vertebral columns stabilized with monocortical screws/polymethylmethacrylate (PMMA). STUDY DESIGN Biomechanical study. SAMPLE POPULATION PVC pipe; cadaveric canine vertebral columns. METHODS PVC model-PVC pipe was used to create a gap model mimicking vertebral endplate orientation and disk space width of large-breed canine cervical vertebrae; 6 models had a 4-mm gap with no spacer (PVC group 1); 6 had a PVC pipe ring spacer filling the gap (PCV group 2). Animals-large breed cadaveric canine cervical vertebral columns (C2-C7) from skeletally mature dogs without (cadaveric group 1, n = 6, historical data) and with an intervertebral disk spacer (cadaveric group 2, n = 6) were used. All PVC models and cadaver specimens were instrumented with monocortical titanium screws/PMMA. Stiffness of the 2 PVC groups was compared in extension, flexion, and lateral bending using non-destructive 4-point bend testing. Stiffness testing in all 3 directions was performed of the unaltered C4-C5 vertebral motion unit in cadaveric spines and repeated after placement of an intervertebral cortical allograft ring and instrumentation. Data were compared using a linear mixed model approach that also incorporated data from previously tested spines with the same screw/PMMA construct but without disk spacer (cadaveric group 1). RESULTS Addition of a spacer increased construct stiffness in both the PVC model (P < .001) and cadaveric vertebral columns (P < .001) compared to fixation without a spacer. CONCLUSIONS Addition of an intervertebral spacer significantly increased construct stiffness of monocortical screw/PMMA fixation.

Biomechanical comparison between bicortical pin and monocortical screw/polymethylmethacrylate constructs in the cadaveric canine cervical vertebral column.

OBJECTIVE To compare biomechanical stiffness of cadaveric canine cervical spine constructs stabilized with bicortical stainless steel pins and polymethylmethacrylate (PMMA), monocortical stainless steel screws with PMMA, or monocortical titanium screws with PMMA. STUDY DESIGN Biomechanical cadaver study. ANIMALS Eighteen canine cervical vertebral columns (C2-C7) were collected from skeletally mature dogs (weighing 22-32 kg). METHODS Specimens were radiographed and examined by dual energy X-ray absorptiometry. Stiffness of the unaltered C4-C5 intervertebral motion unit was measured in extension, flexion and lateral bending using non-destructive 4-point bend testing. Specimens were then stabilized by (1) bicortical stainless steel pins/PMMA, (2) monocortical stainless steel screws/PMMA, or (3) monocortical titanium screws/PMMA. Mechanical testing was repeated and stiffness data from unaltered specimens and the 3 treatment groups were compared. RESULTS All 3 surgical methods significantly increased stiffness of the C4-C5 motion unit compared with the unaltered specimen (P < .001 for all treatments), but stiffness was not significantly different among the 3 fixation groups (P = .578). CONCLUSIONS In this model, monocortical screw fixation (with stainless steel or titanium screws) was biomechanically equivalent to bicortical fixation.

Stiffness, Strength, and Failure Modes of Implant-Supported Monolithic Lithium Disilicate Crowns: Influence of Titanium and Zirconia Abutments

PURPOSE The objective of this study was to evaluate stiffness, strength, and failure modes of monolithic crowns produced using computer-aided design/computer-assisted manufacture, which are connected to diverse titanium and zirconia abutments on an implant system with tapered, internal connections. MATERIALS AND METHODS Twenty monolithic lithium disilicate (LS2) crowns were constructed and loaded on bone level-type implants in a universal testing machine under quasistatic conditions according to DIN ISO 14801. Comparative analysis included a 2 × 2 format: prefabricated titanium abutments using proprietary bonding bases (group A) vs nonproprietary bonding bases (group B), and customized zirconia abutments using proprietary Straumann CARES (group C) vs nonproprietary Astra Atlantis (group D) material. Stiffness and strength were assessed and calculated statistically with the Wilcoxon rank sum test. Cross-sections of each tested group were inspected microscopically. RESULTS Loaded LS2 crowns, implants, and abutment screws in all tested specimens (groups A, B, C, and D) did not show any visible fractures. For an analysis of titanium abutments (groups A and B), stiffness and strength showed equally high stability. In contrast, proprietary and nonproprietary customized zirconia abutments exhibited statistically significant differences with a mean strength of 366 N (Astra) and 541 N (CARES) (P < .05); as well as a mean stiffness of 884 N/mm (Astra) and 1,751 N/mm (CARES) (P < .05), respectively. Microscopic cross-sections revealed cracks in all zirconia abutments (groups C and D) below the implant shoulder. CONCLUSION Depending on the abutment design, prefabricated titanium abutment and proprietary customized zirconia implant-abutment connections in conjunction with monolithic LS2 crowns had the best results in this laboratory investigation.

Complications with computer-aided designed/computer-assisted manufactured titanium and soldered gold bars for mandibular implant-overdentures: short-term observations

BACKGROUND Implant-overdentures supported by rigid bars provide stability in the edentulous atrophic mandible. However, fractures of solder joints and matrices, and loosening of screws and matrices were observed with soldered gold bars (G-bars). Computer-aided designed/computer-assisted manufactured (CAD/CAM) titanium bars (Ti-bars) may reduce technical complications due to enhanced material quality. PURPOSE To compare prosthetic-technical maintenance service of mandibular implant-overdentures supported by CAD/CAM Ti-bar and soldered G-bar. MATERIALS AND METHODS Edentulous patients were consecutively admitted for implant-prosthodontic treatment with a maxillary complete denture and a mandibular implant-overdenture connected to a rigid G-bar or Ti-bar. Maintenance service and problems with the implant-retention device complex and the prosthesis were recorded during minimally 3-4 years. Annual peri-implant crestal bone level changes (ΔBIC) were radiographically assessed. RESULTS Data of 213 edentulous patients (mean age 68 ± 10 years), who had received a total of 477 tapered implants, were available. Ti-bar and G-bar comprised 101 and 112 patients with 231 and 246 implants, respectively. Ti-bar mostly exhibited distal bar extensions (96%) compared to 34% of G-bar (p < .001). Fracture rate of bars extensions (4.7% vs 14.8%, p < .001) and matrices (1% vs 13%, p < .001) was lower for Ti-bar. Matrices activation was required 2.4× less often in Ti-bar. ΔBIC remained stable for both groups. CONCLUSIONS Implant overdentures supported by soldered gold bars or milled CAD/CAM Ti-bars are a successful treatment modality but require regular maintenance service. These short-term observations support the hypothesis that CAD/CAM Ti-bars reduce technical complications. Fracture location indicated that the titanium thickness around the screw-access hole should be increased.

Simple Accuracy Enhancing Techniques in Neuronavigation.

BACKGROUND Neuronavigation is an essential tool in cranial neurosurgery. Despite continuing improvements in the technologies used for neuronavigation, certain events can lead to unacceptable mismatches. To provide the best possible outcome for the patients, surgeons need to do everything possible to reduce mismatches. METHODS AND RESULTS Some simple techniques can greatly improve neuronavigation accuracy and patient safety. We describe two simple methods that were developed or refined in the Department of Neurosurgery at Inselspital, Bern, Switzerland: the transdermal navigation landmark and use of bone screws for co-registration. CONCLUSIONS Both techniques are easy to use, do not require expensive additional instruments, and are helpful in procedures involving neuronavigation.

Surgical exposures and options for instrumentation in acetabular fracture fixation: Pararectus approach versus the modified Stoppa.

BACKGROUND As an alternative to the modified Stoppa approach, the Pararectus approach is used clinically for treatment of acetabular fractures involving the anterior column. The current study assessed the surgical exposure and the options for instrumentation using both of these approaches. METHODS Surgical dissections were conducted on five human cadavers (all male, mean age 88 years (82-97)) using the modified Stoppa and the Pararectus approach, with the same skin incision length (10cm). Distal boundaries of the exposed bony surfaces were marked using a chisel. After removal of all soft-tissues, distances from the boundaries in the false and true pelvis were measured with reference to the pelvic brim. The exposed bone was coloured and calibrated digital images of each inner hemipelvis were taken. The amount of exposed surface using both approaches was assessed and represented as a percentage of the total bony surface of each hemipelvis. For instrumentation, a suprapectineal quadrilateral buttress plate was used. Screw lengths were documented, and three-dimensional CT reconstructions were performed to assess screw trajectories qualitatively. Wilcoxon's signed rank test for paired groups was used (level of significance: p<0.05). RESULTS After utilization of the Pararectus approach, the distances from the farthest boundaries of exposed bone towards the pelvic brim were significantly higher in the false but not the true pelvis, compared to the modified Stoppa approach. The percentage (mean±SD) of exposed bone accessible after utilizing the Pararectus approach was 42±8%, compared to 29±6% using the modified Stoppa (p=0.011). In cadavers exposed by the Pararectus approach, screws placed for posterior fixation and as a posterior column screw were longer by factor 1.8 and 2.1, respectively (p<0.05), and screws could be placed more posteromedial towards the posterior inferior iliac spine or in line with the posterior column directed towards the ischial tuberosity. CONCLUSION Compared to the modified Stoppa, the Pararectus approach facilitates a greater surgical access in the false pelvis, provides versatility for fracture fixation in the posterior pelvic ring and allows for the option to extend the approach without a new incision.