The accuracy of pedicle screw placement is essential for successful spinal reconstructive surgery. The authors of several previous studies have described the use of image-based navigational templates for pedicle screw placement. These are designed based on a pre-operative computed tomographic (CT) image that fits into a unique position on an individual's bone, and holes are carefully designed to guide the drill or the pedicle probe through a pre-planned trajectory. The current study was conducted to optimise navigational template design and establish its designing method for safe and accurate pedicle screw placement.

Thin-section CT scans were obtained from 10 spine surgery patients including 7 patients with adolescent idiopathic scoliosis (AIS) and three with thoracic ossification of the posterior longitudinal ligament (OPLL). The CT image data were transferred to the commercially available image-processing software and were used to reconstruct a three-dimensional (3D) model of the bony structures and plan pedicle screw placement. These data were transferred to the 3D-CAD software for the design of the template. Care was taken in designing the template so that the best intraoperative handling would be achieved by choosing several round contact surfaces on the visualised posterior vertebral bony structure, such as transverse process, spinous process and lamina. These contact surfaces and holes to guide the drill or the pedicle probe were then connected by a curved pipe. STL format files for the bony models with planned pedicle screw holes and individual templates were prepared for rapid prototype fabrication of the physical models. The bony models were made using gypsum-based 3D printer and individual templates were fabricated by a selective laser melting machine using commercially pure titanium powder. Pedicle screw trajectory of the bony model, adaptation and stability of the template on the bony model, and screw hole orientation of the template were evaluated using physical models. Custom-made titanium templates with adequate adaptation and stability in addition to proper orientation of the screw holes were sterilised by autoclave and evaluated during surgery.

During segmentation, reproducibility of transverse and spinous processes were inferior to the lamina and considered inadequate to select as contact surfaces. A template design with more bone contact area might enhance the stability of the template on the bone but it is susceptible to intervening soft tissue and geometric inaccuracy of the template. In the bony model evaluation, the stability and adaptation of the templates were sufficient with few small round contact surfaces on each lamina; thus, a large contact surface was not necessary. In clinical patients, proper fit for positioning the template was easily found manually during the operation and 141/142 screws were inserted accurately with 1 insignificant pedicle wall breach in AIS patient.

This study provides a useful design concept for the development and introduction of custom-fit navigational template for placing pedicle screws easily and safely.

Kokubo and one of the present authors (T.N) have developed a new technique of bioactive coating using alkaline and heat treatment, which induces the formation of a thin HA layer on the surface of titanium after implantation in the body. This new coating technique is not associated with degradation or separation of the HA coating, because a bone-like apatite layer of 1 μm in width begins to form in the body tissue after implantation.

Chemically and thermally treated titanium possesses bone-bonding ability, which has been confirmed by detachment tests. Bone ingrowth into bioactive titanium continues to increase throughout the 26 weeks of implantation, whereas bone ingrowth into non-treated or HA plasma coating implants tends to decrease between 6 and 12 weeks. These findings suggest the long-term stability and osteoconduction of the bioactive layer of chemically and thermally treated titanium.

We carried out a series of 70 cementless primary total hip arthroplasties using this coating technique on a porous titanium surface, and followed up the patients for a mean period of 4.8 years. There were no instances of loosening or revision, or formation of a reactive line on the porous coating. Although radiography just after surgery showed a gap between the host bone and the socket in 70% of cases, all the gaps disappeared within a year, indicating the good osteoconduction provided by the coating. Alkaline-heat treatment of titanium to provide a HA coating has several advantages over plasma-spraying, including no degeneration or absorption of the HA coating, simplicity of the manufacturing process, and cost effectiveness. In addition, this method allows homogeneous deposition of bone-like apatite within a porous implant.

Although this was a relatively short-term study, treatment that creates a bioactive surface on titanium and titanium alloy implants has considerable promise for clinical application.

In cementless fixation system, surface character becomes important factor. Alkali and heat treatments on titanium metal has been proved to show strong bonding to bone and higher ongrowth rate. In this study we examined the effect of alkali and heat treatments on titanium rod in rabbit femur intramedurally model, in consideration of cementless hip stem. The implant had a 5mm in diameter and 25 mm in length. The implants were and half of them were immersed in 5 mol/L sodium hydroxide solution and heated at 600 åé for one hour (AH implant), and the other half were untreated (CL implant). The implants were implanted into the distal femur of the rabbits, AH implant into left femur and CL implants into right. The bone-implant interfaces were evaluated at 3, 6, and 12 weeks after implantations.

Pull-out tests showed that AH implants significantly higher bonding strength to bone than CL implants at each week after operations. At 12 weeks mean pull-out load of AH implants was 411.7 N and that of CL implants 72.2 N. As postoperative time elapsed, histological examination revealed that new bone form on the surface of the both types of the implants, but significantly more bone contacted directly on the surface of AH implants. At 12 weeks AH implant was covered by the newly formed bone about 56% of the whole surface of the implants and CL implants was about 19%.

In conclusion, alkali- and heat-treated titanium offers strong bone-bonding and high affinity to bone instead of conventional mechanical interlocking mechanism. Alkali and heat treatments on titanium may be applicable to the surface treatment for cementless joint replacement implant.