Transaxial-nondecalcified sections were made at 5 mm intervals through the operated segments of the spine and included the entire implant area. Decalcified sections stained with hematoxylin and eosin were also prepared from the operative and implant areas. This material has been investigated in porous rod and particulate forms and has shown good short-term biocompatibility in previous studies.
Dense calcium hydroxylapatite Durapatite, Sterling-Winthrop, Ine, NY , Ca10 P04 6 OH 2, has been formulated in particulate and block form for the surgical reconstruction of bone lesions. A sterile non-porous 14 mesh particulate form was used in this study. This biomaterial has been used in bulk and particulate form and as a coating on alumina and alloy substrates.
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A number of reports have summarized the BG bone interfacial bonding characteristics and the potential for future applications. A dry heat sterilized, irregular-sized particulate form was used. Loops of 16 or 18 stainless steel L suture wire were used under the lamina in one instance and looped around the spinous processes in four dogs.
The author's rationale was to simulate posterior and anterior fusion procedures used clinically with the various combinations of biomaterials and not to compare the performance of one material with another or with the site of implantation. In each anterior and posterior procedure, one or more of the synthetic bioceramics was used in combination with stainless steel wire in order to test compatability. There were no systemic untoward reactions in the implanted dogs associated with the surgery.
Radiographs taken at 3 months showed no change in the position of the ceramic implants or suture wires.
PEEK performance: a next-generation biomaterial
At 3 months, there was no evidence of bony fusion. Radiographic evidence of fusion was not found in the other animals. The three other lumbar spines examined at necropsy showed no gross evidence of bony fusion, unusual tissue reactions, or new periosteal bone formation. Gross examination of the thoracic spines showed containment of the implants and wires within the cavity created between adjacent vertebral bodies. No untoward tissue reaction was noted, nor was there gross evidence of bony fusion or complete incorporation of the implants with bone.
It should be stressed that the cavity preparation did not create a large region of decorticated bone. The region was usually 3 to 4 mm in greatest diameter. Nondecalcified sections demonstrated mature trabecular bone in the decorticated areas growing in and around the implant particulate to varying degrees. In dog , abundant new bone formation surrounded the HAP particulate and appeared to grow through the entire particulate region Fig.
A similar finding was noted in the thoracic spine with HAP Fig.
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Note bony trabeculae near but not within TCP particulate x 15, dog L. Bioglass crystals were surrounded by thin, fibrous capsules, around which bony trabeculae were noted Fig. The hematoxylin and eosin sections showed no significant inflammatory or foreign body reactions Fig. All implant combinations seemed largely unchanged in morphology. The stainless steel wire provoked no untoward tissue response either alone or when located adjacent to the synthetic bioceramics.
Note BG crystals arrow surrounded by a thin, fibrous capsule x 15, dog L. Although there was no way of quantitating the amount of biomaterial particulate remaining at necropsy, very little appeared to be resorbed. The results of this preliminary study wherein four mongrel dogs carried eight types of spinal implants for at least 6 months indicated no untoward local or systemic effects of these ceramic or metallic materials.
Preparation of a good bony fusion bed exposing cancellous bone for future cellular and vascular ingrowth appeared to be an advantage in order to achieve a fusion using one or more of these biomaterials. However, the limits of small numbers must be emphasized. Individually or in combination, these substances did not promote or cause fusion to occur. These bioceramics appear to provide a scaffolding upon which creeping bone formation occurs.
Invasion of these implants by bone did occur at some sites if the particulate mesh size porosity was adequate to accomodate the bony trabeculae.
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The BG appeared to be surrounded by a thin, fibrous capsule around which bone was laid down. This may have been caused by relative mechanical movement. Invasion of individual BG crystals by bone was not seen.
The TCP particulate was surrounded but not invaded by bony trabeculae. The particulates did not appear to be extensively degraded or resorbed at either site studied during the 6 to 8 months of implantation. The HAP appeared to be most consistently associated with bony trabeculae and appeared to be most involved with the fusion process. Superiosteal stripping of the posterior lumbar spine in these mature dogs did not result in significant new bone formation in contrast to decortication which did.
No inflammatory reaction was noted XlS, dog L. Flatley et al implanted porous calcium phosphates in the vertebral columns of 21 rabbits. Dawson et al used replaminiform hydroxylapatite implanted in the anterior surface of two adjoining lumbar vertebrae in dogs. They observed a greater degree of bony ingrowth and bone to implant contact where large implant porosity allowed for adequate tissue ingrowth. The authors concur with Flatley and Dawson that both porous tricalcium phosphate and hydroxylapatite show promise as effective biosynthetic bone substitutes.
In summary, tricalcium phosphate and hydroxylapatite incorporate within the fusion mass, in contrast to Bioglass which is encapsulated by a fibrous tissue interface. None of the materials studied stimulate or promote new bone formation. These biomaterials were encorporated into the tissues without adverse reaction. Fusion occurred only with the addition of autogenous iliac crest bone. These biomaterials provide volume filling but do not necessarily enhance new bone formation.
AU of the combinations were acceptable when used together and were compatible with stainless steel. The Bioglass showed a thin, fibrous encapsulation with some adjacent bony trabeculae. The relative positioning of the biomaterials was quite critical to the tissue response, as was the degree of surgical preparation by decortication or merely by subperiosteal stripping. Trends found for the biomaterials implanted independently were similar to those used in combination.
The presence of the suture wire at all surgical sites did not result in unusual reaction. Hibbs RA: Report of 59 cases of scoliosis treated by the fusion operation. J Bone Joint Surg ; Cobb JR: Spine arthrodesis in the treatment of scoliosis. Moe JH: A critical analysis of methods of fusion for scoliosis. J Bone Joint Surg ; 40A Watkins MB: Posterior lateral bone grafting for fusion of the lumbar and lumbosacral spine.
The fact that many of these procedures will now be using PEEK polymer-based devices is a key solution to this problem.
Biomaterials for Spinal Surgery
Regenerative applications Within the past decade, PEEK polymers have matured into an established and widely accepted family of biomaterials for spinal devices, agrees Kurtz. But researchers are not stopping there and are pushing at the boundaries to see where PEEK could be used in the future. There has been, for example, growing interest in the potential benefits of enhancing the osseo-conductivity of PEEK with coatings to provide direct bone ongrowth.
Similarly, PEEK research is at the forefront of tackling the long-term challenge of surgical site infection, with researchers excited about how PEEK tissue scaffolds and anti-microbial formulations may help in this area.
Its key biomechanical advantages in this context are that it is much more flexible and motion preserving," says Kurtz. There is a lot of cutting-edge research going on around this. PEEK is a very inert material — which is great because you obviously want implants to be as bio-inert as possible," he adds.
We want materials to play a greater role in tissue healing; materials need to be more integrated within the healing process and not just be passive," Kurtz continues. Rather than sitting by the bone and letting it get on with it, it is actively encouraging bone growth," he adds. The bone interdigitates with the implant so that you get the tightest interface possible," explains Kurtz.