Biodegradation of Inion Fast-Absorbing Biodegradable Plates and Screws

Abstract

Biodegradable plates and screws are recommended for use in surgery of the craniofacial skeleton of children. To be effective and not interfere with growth of the child's skull, the plates must biodegrade sufficiently to release the holding power of the plate and screw within 1 year. It is also essential that excessive foreign body reaction and cyst formation does not occur when the plates and screws biodegrade. The purpose of this experimental study was to evaluate the rate of biodegradation of Inion CPS Baby biodegradable plates and screws under different clinical circumstances in the rabbit craniofacial skeleton and evaluate their efficacy for use in pediatric craniofacial surgery. Foreign body reaction would be evaluated. Inion baby plates and screws were tested in a rabbit model. Plates were applied to the frontal bone, over a bony defect of the parietal bone, to a nasal bone fracture, and inserted in the subcutaneous space over the occipital bone in thirty 6-week-old rabbits. Six rabbits were euthanized at 9, 12, 15, and 18 months' postoperative time point and examined for residual plates and screws. Bone from each surgical site was excised, fixed by immersion in 10% neutral-buffered formalin, decalcified in Immunocal solution, and examined by 7-microm paraffin sections stained with hematoxylin and eosin. At 9 months, the plates and screws had effectively biodegraded and no longer had holding power on the bones. Fragmentation of the implant material was noted. Residual implant material was still present on gross and histologic examination in rabbits at 9, 12, 15, and 18 months. Residue of a screw was still palpable in 1 rabbit at 18 months. There was no evidence of cyst formation in any of the examined specimens. Macrophages and giant cells were present in most of the specimens at 9, 12, 15, and 18 months. Findings from the current study revealed a relative short resorption time (9 mo) and normal inflammatory sequelae in an adult rabbit model. These findings suggest that these plates may be used safely in fixing the pediatric craniofacial skeleton.

Delayed Foreign-body Reaction to Absorbable Implants in Metacarpal Fracture Treatment

“…In animal models, these implants showed normal inflammatory sequelae [22,25]. Similarly, the incidence of foreign-body reactions was extremely low in some clinical applications, including maxillofacial surgery [20,21,33] and in a series of pediatric patients [23].…”

“…Recent recommendations suggest using the minimum possible implant size to reduce the amount of breakdown products [33]. Moreover, an increased frequency of adverse soft tissue reactions may occur owing to poor vascularity of the implantation site and an insufficient layer of soft tissue [5,22]. Thus, the relatively high intensity and frequency of foreign-body reactions in the metacarpals may be attributable to the proximity of avascular tendons, relative paucity of subcutaneous fat, and insufficient muscle vascularity for efficient clearance of large implants and abundant degradation products.…”

“…Third-generation implants composed of trimethylene carbonate, L-lactide, and D, L-lactide displayed improved strength and slow degradation rates (2-4 years). These were designed to overcome the problems of rapidly diminishing strength and frequent foreign-body reactions [22,23,25]. However, the prolonged degradation rate of new implants has raised further concerns.…”

“…A major concern is whether these materials actually diminish adverse soft tissue reactions or whether the reactions simply are postponed to a later time ? These bioabsorbable implants have been studied extensively in vitro and in animal models [22,25], but only few short-term studies were conducted in humans [20,33].…”

Conformational Study of Polypeptide Chains Grafted on the Surface of Polylactide Latex Particle

“…Much research aimed at applications of PLA materials and peptide derivatives has been carried out. For example, a PLA scaffold for bone regeneration and a PLA screw for bone fixation as an application of the biodegradable characteristics has been already examined [1][2][3]. Many groups have applied the biocompatibility of polypeptides to a wound dressing [4], MRI contrast agents [5], and tissue engineering [6].…”