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Biomedical subjects

R R Bos

Publications and source records attributed to R R Bos.

At least 37 records · Page 2Linked to original sources

Poly(L-lactide) bone plates and screws for internal fixation of mandibular swing osteotomies.

This study evaluated bone healing after mandibular swing osteotomies fixed with biodegradable poly(L-lactide) (PLLA) bone plates in four patients. A step osteotomy treated with two PLLA bone plates (n=3), and a straight osteotomy treated with one PLLA bone plate (n=1) were performed. Bone healing was uneventful in all patients; only in the patient with the straight osteotomy was callus observed. After 5.5 years, radiologic changes at the site of implantation were observed in the remaining patient. Histologic examination revealed a nonspecific foreign-body reaction on highly crystalline PLLA remnants which were still present. It is concluded that the PLLA bone plates provided enough strength to enable undisturbed bone healing. The long-term degradation results are comparable with those of other studies on as-polymerized PLLA implants.

Biodegradation, Environmental↗

Biocompatibility study of as-polymerized poly(L-lactide) in rats using a cage implant system.

To evaluate the biocompatibility of in vitro predegraded as polymerized poly(L-lactide) (PLLA), a cage implant system was used to investigate white cell and enzyme concentrations with time. The use of a cage permits in a serial fashion a quantitative and qualitative measurement of exudate components formed around an implant. Subcutaneously in rats, caped cages manufactured from stainless-steel mesh were implanted with in vitro predegraded, as-polymerized PLLA, as-polymerized PLLA cylinders, and empty cages serving as controls. In vitro predegradation was used to simulate the degradation products of long-term in vitro degradation. Predegraded PLLA particles were obtained by in vitro hydrolysis at elevated temperatures. The first 7 days of implantation were characterized by an acute inflammatory reaction; the exudate extracted from the cages showed predominantly neutrophils for all types of implants. After day 7, there was a more chronic inflammatory reaction with predominantly macrophages and lymphocytes. There were no significant differences in the total leukocyte concentration or macrophage concentration for any of the cages in the period from 10-21 days. Extracellular enzyme activity also did not show any significant differences among the three types of cages. A possible explanation for the absence of any significant differences could be that the in vitro predegraded particles were sieved before implantation, thus eliminating all small particles (< 70 microns) that are probably mandatory to provoke an increased cellular reaction.

Animals↗

Late degradation tissue response to poly(L-lactide) bone plates and screws.

Patients with fractures of the zygomatic bone were treated with high molecular weight poly(L-lactic) acid (PLLA) bone plates and screws. Three years after implantation four patients returned to our department with a swelling at the site of implantation. At the recall of the remaining patients we found an identical type of swelling after the same implantation period. To investigate the nature of the tissue reaction, eight patients were reoperated for the removal of the swelling. The implantation period of the PLLA material varied from 3.3 to 5.7 years. Microscopic evaluation and molecular weight measurements were performed. The excised material showed remnants of degraded PLLA material surrounded by a dense fibrous capsule. Ultrastructural investigation showed crystal-like PLLA material internalized by various cells. The results of this investigation suggest that the PLLA material slowly degrades into particles with a high crystallinity. The intra- and extracellular degradation rate of these particles is very low. After 5.7 years of implantation, these particles were still not fully resorbed.

Acid Phosphatase↗

In vivo degradation and biocompatibility study of in vitro pre-degraded as-polymerized polyactide particles.

The degradation of high molecular weight as-polymerized poly(L-lactide) (PLLA) is very slow; it takes more than 5.6 yr for total resorption. Moreover, the degradation products of as-polymerized PLLA bone plates, consisting of numerous stable particles of high crystallinity, are related with a subcutaneous swelling in patients 3 yr postoperatively. In order to avoid these complications, polymers were developed that are anticipated to have comparable mechanical properties but a higher degradation rate and do not degrade into highly stable particles that can induce a subcutaneous swelling. On chemical grounds it can be expected that copolymerization of PLLA with 4% D-lactide (PLA96) or by modifying PLLA through cross-linking (CL-PLLA) will lead to less stable particles and a higher degradation rate. To evaluate the long-term suitability of these as-polymerized polymers, the biocompatibility of the degradation products should be studied. Considering the very slow degradation rate of as-polymerized PLLA, in vitro pre-degradation at elevated temperatures was used to shorten the in vivo follow-up periods. In this study, the biocompatibility and degradation of as-polymerized PLLA, PLA96 and CL-PLLA were investigated by implanting pre-degraded particulate materials subcutaneously in rats. Animals were killed after a postoperative period varying from 3 to 80 wk. Light and electron microscopical analysis and quantitative measurements were performed. The histological response of all three pre-degraded materials showed a good similarity with in vivo implanted material. Pre-degraded PLLA induced a mild foreign body reaction and showed a slow degradation rate.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

High-impact poly(L/D-lactide) for fracture fixation: in vitro degradation and animal pilot study.

The impact strength of amorphous lactide copolymers can be significantly improved by blending with biodegradable rubbers. Rubber toughening of amorphous poly(85L/15D -lactide) with the copolymer poly (50/50-trimethylenecarbonate-co-epsilon-caprolactone) results in a high-impact polymer (PDLLA/P(TMC-CL)). In vitro, the PDLLA/P(TMC-CL) blend retained its tensile and impact strength for a long period of time. Up to 45 weeks, the amount of water absorbed by the blend remained very low and no significant mass loss was observed. To test the suitability for fracture fixation, in a dog study mandibular fractures were fixated with PDLLA/P(TMC-CL) bone plates and screws. Bone healing was uneventful without premature failure of the implants. Although long-term degradation studies have to be carried out, PDLLA/P(TMC-CL) seems to be promising for application in fracture fixation.

Animals↗

Foreign body reactions to resorbable poly(L-lactide) bone plates and screws used for the fixation of unstable zygomatic fractures.

In a previous article in the Journal of Oral and Maxillofacial Surgery, the initial results of treating 10 patients with solitary, unstable, displaced zygomatic fractures using resorbable poly(L-lactide) (PLLA) plates and screws was reported (Bos et al, 1987). This article describes the long-term results in these patients. Three years postoperatively, four patients returned because they were concerned about an intermittent swelling at the site of implantation. The remaining patients were recalled after the same postoperative period. All patients were examined clinically, and six patients were operated on again for evaluation of the swelling and to investigate the nature of the tissue reaction. The explanted material showed remnants of degraded PLLA surrounded by a dense fibrous capsule. The swelling was classified as a nonspecific foreign body reaction to the degraded PLLA material. Ultrastructural investigation of the degraded material showed an internalization of crystal-like PLLA material in the cytoplasm of various cells.

Adult↗

Computer-aided optimization of choice and positioning of bone plates and screws used for internal fixation of mandibular fractures.

The present study describes a biomechanical integrated model of the mandibular system in which the maxilla and mandible, the masticatory muscles, and the temporomandibular joints are regarded as one system. In this model, strains in plate-osteosynthesis devices for internal fixation of mandibular fractures can be minimized by optimizing their positions. The model evaluates maximal bite force strategies on all possible dental elements; it uses a linear programming technique and a muscle architecture model, resulting in muscle recruitment patterns. The shape of a "standard" lower jaw is digitized by means of a three-dimensional (3-D) coordinate retrieval device and drawn on a computer screen after its dimensions have been changed according to the clinical case at hand. The 3-D location of the fracture as well as the anatomic restrictions for screw placement can be indicated on the screen. Osteosynthesis devices can be indicated in terms of dimensions, number, and material properties.

Biomechanical Phenomena↗

The effects of different steam-sterilization programs on material properties of poly(L-lactide).

As-polymerized poly(L-lactide) test rods were sterilized by seven different specially designed computer-operated autoclaving programs. As a control, common hospital sterilization was performed. In all cases, the molecular weight decreased after sterilization. A short time high-temperature sterilization led to less molecular weight decrease than a low sterilization temperature cycle with a longer sterilization time. Regular hospital sterilization significantly reduced the elongation at break and also resulted in a decrease of 35% in tensile strength. The program causing minimal damage to the material properties was studied in detail. This program, with a sterilization period of 60 s and 129 degrees C, was effective for PLLA sterilization and also looks very promising for sterilization of other thermo- and moisture-labile polymers.

Humans↗

Degradation of and tissue reaction to biodegradable poly(L-lactide) for use as internal fixation of fractures: a study in rats.

Samples of high-molecular-weight poly(L-lactide) (PLLA) (Mv = 9.0 x 10(5), a biomaterial developed for plates and screws used in internal fixation of jaw fractures, were implanted subcutaneously in the backs of rats to study tissue reaction to PLLA and to follow the degradation process. The PLLA seemed to follow the degradation pattern typical of biodegradable polyesters. After pure hydrolysis up to about 104 wk, phagocytic activity of macrophages was found at about 143 wk. Full resorption of PLLA was not demonstrated in this study. Except for the early and final parts of the implant period, no acute or chronic inflammatory reaction was observed. No implant was rejected. It is estimated that more than 3 yr will be required for total resorption of PLLA. For bone-healing this long period is of no practical importance. There is no need for removal of PLLA after fracture healing as is the case with metal fixation devices. Thus, PLLA has potential application in internal fixation of fractures and osteotomies in the maxillofacial region and other fractures that are not too heavily loaded in the human body.

Animals↗

Poly(L-lactide) implants in repair of defects of the orbital floor: an animal study.

Because of the life-long presence of alloplastic, nonresorbable orbital floor implants and the complications of their use mentioned in literature, the use of a resorbable material appears to be preferable in the repair of orbital floor defects. A high-molecular-weight, as-polymerized poly(L-lactide) (PLLA) was used for repair of orbital floor defects of the blowout type in goats. An artificial defect was created in the bony floor of both orbits. Reconstruction of the orbital floor was then carried out using a concave PLLA implant of 0.4-mm thickness. At 3, 6, 12, 19, 26, 52, and 78 weeks postoperatively, one goat was killed. Microscopic examination showed full encapsulation of the implant by connective tissue after 3 weeks. After 6 weeks, resorption and remodeling of the bone at the points of support of the implant could be detected. A differentiation between the sinus and orbital sides of the connective tissue capsule was observed. The orbital side showed a significantly more dense capsule than the antral side, which had a loose appearance. At 19 weeks, a bony plate was progressively being formed, and at 78 weeks, new bone had fully covered the plate on the antral and orbital side. No inflammation or rejection of the PLLA implant was seen.

Animals↗

Influence of resorbable poly(L-lactide) bone plates and screws on the dose distributions of radiotherapy beams.

Metallic bone plates have been shown to affect radiation in vitro. Although no damage has ever been demonstrated in vivo these plates may cause dose enhancements and shielding of the adjacent tissue. Resorbable high molecular weight as-polymerized poly(L-lactide) (PLLA) bone plates have recently been used for reconstruction in the maxillofacial area. To determine their influence on dose distribution, a 4-hole bone plate and screws of PLLA were exposed to electron and photon beams. A tissue-equivalent phantom of perspex was irradiated and measurements were made with LiF thermoluminescent dosimeters. No significant changes in dose deviations could be determined when the dose distribution in the homogeneous phantom was compared with that of the phantom in which the PLLA material was placed. From this study it can be concluded that the PLLA material can be regarded as tissue-equivalent and can, thus, be safely used for fracture fixation of bone fragments when postoperative irradiation is anticipated.

Bone Plates↗

Experimental fractures of the mandibular body of sheep and dogs. A new technique.

In order to create artificial fractures in animals resembling those which occur naturally, a new technique for fracture production was developed. Using a specially designed clamp, artificial fractures were produced in the mandibular body of seven sheep and 12 dogs. Radiographical analysis of the effects of the clamp on the mandibular body showed simple, single vertical fractures in the buccal cortex, inferior border and the alveolar process comparable to those which occur naturally. Using the technique described it was possible, in all cases, to carry out treatment with the use of 4-hole poly(L-lactide) plates and screws.

Animals↗

Bone-plates and screws of bioabsorbable poly (L-lactide)--an animal pilot study.

Poly (L-lactide), a polymer of lactic acid (PLLA), with an extremely high molecular weight (Mv up to 1 x 10(6] has been synthesised under strictly controlled conditions resulting in a new microporous material with excellent mechanical properties. Bone-plates and screws machined from PLLA were used for fixation of two artificial mandibular fractures in sheep effected by a specially designed bone clamp. Fracture healing was uneventful without visible callus formation. Plates and screws of PLLA gave good stability over a sufficiently long period to enable normal fracture healing. Application in humans seems to be justified.

Absorption↗

Bio-absorbable plates and screws for internal fixation of mandibular fractures. A study in six dogs.

Bio-absorbable plates and screws were used for internal fixation of artificially created mandibular fractures in 6 dogs. The plates and screws were fabricated from a block of poly(L-lactide) (PLLA), with a high molecular weight. The material is microporous and has excellent mechanical properties. Plates and screws were inserted in accordance with Champy's principles on internal fixation. Clinical and radiographical follow-up and examination of the fracture site under general anesthesia showed that all fractures healed without callus and without complications. The plates or screws did not fail, despite the tensile strength of the PLLA used is less than stainless steel or any other metal. An explanation for their successful application may be the high impact resilience of this material. The proprioceptive mechanisms, however, that keep the dogs from maximal loading of their broken mandibles, may also play a role. Plates and screws of this bio-absorbable PLLA appear to be an attractive alternative for internal fixation of mandibular fractures and certainly for less loaded fractures of the human skeleton. The necessity to remove metallic osteosynthesis can be avoided.

Absorption↗

Resorbable materials of poly(L-lactide). VI. Plates and screws for internal fracture fixation.

Poly(L-lactide) (PLLA) with an extremely high molecular weight (Mv up to 1 X 10(6)) was synthesized at a low catalyst concentration (0.015 wt%) and temperatures between 100-110 degrees C. Besides good mechanical properties the as-polymerized PLLA exhibited a microporous structure. Plates and screws of this material were used for the treatment of mandibular fractures, both in dogs and in sheep. Bone healing was uneventful and proceeded without callus formation or signs of inflammation. Fracture healing was accompanied by a progressive degradation of the microporous implants of PLLA.

Animals↗

Resorbable materials of poly(L-lactide). VII. In vivo and in vitro degradation.

In vivo and in vitro degradation of high molecular weight poly(L-lactide) used for internal bone fixation has been investigated. Within 3 months as-polymerized, microporous PLLA (Mv = 6.8-9.5 X 10(5] exhibited a massive strength-loss (sigma b = 68-75 MPa to sigma b = 4 MPa) and decrease of Mv (90-95%). At week 39, the first signs of resorption were evident (mass-loss 5 wt%). Except for dynamically loaded bone plates no differences between in vivo and in vitro degradation of PLLA were observed. The increase of crystallinity of PLLA upon degradation (up to 83%) is likely to be attributed to recrystallization of tie-chain segments. A more ductile PLLA exhibiting a lower rate of degradation was prepared by extraction of low molecular weight compounds with ethyl acetate.

Animals↗