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Comparison of tensile strength of resorbable plating systems used in monocortical mandible angle osteotomy repair.

OBJECTIVE: To determine the usefulness of resorbable plating systems in load-bearing applications of the mandible and the location of critical failure. METHODS: An osteotomy was created in 24 fresh cadaveric mandibles at the angle and fixated by the Champy technique with similar resorbable craniofacial plating systems from 4 manufacturers. Each mandible was held rigid as a material test system applied a downward force anteriorly. The critical tolerance was measured and the type of failure was noted. RESULTS: Critical failure occurred at forces from 34.6 to 137.8 N. We found a statistically significant difference between the plating groups (P<.001 for all comparisons). The point of failure was almost uniformly at the plate. CONCLUSIONS: Critical failure was overwhelmingly due to rupture of the plate rather than to stripping or shearing of the screws as had been strongly expected. We found differences in plate strengths for this particular application and did not evaluate their respective long-term resorptive properties. We do not advocate that single resorbable plate fixation be the sole means of mandible angle fracture fixation, regardless of the plating system used.

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A simplified approach to midface aging.

We review herein our experience with subperiosteal midface-lifting under direct vision with a simple fixation technique. The technical aspects of the procedure are described in detail. A total of 121 patients underwent midface-lifting and meloplication with the 82/18 L-lactide/glycolide device (Coapt Endotine Midface ST 4.5; Coapt Technologies, Palo Alto, Calif) by both the senior (G.S.K.) and junior (R.N.H.) authors. The senior author's experience included 110 patients over a 26-month period. Thirty-two of these cases were isolated procedures. The other 78 were performed in conjunction with various procedures, most commonly rhytidectomy. There were no revisions during this period. Two cases of "puckering" were noted. Both were immediately corrected, one with fat injection and one with poly-L-lactic acid injection (Sculptra; Dermik Aesthetics, distributed by Besse Medical Supply, West Chester, Ohio). The junior author's experience included 11 cases over an 8-month period. Two cases of asymmetry were noted. One was corrected with fat injection, and the other required revision. Subperiosteal midface-lifting and meloplication using the Coapt Endotine Midface ST 4.5 device is a simple, effective technique that can be quickly learned and applied.

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Retinal progenitor cell xenografts to the pig retina: morphologic integration and cytochemical differentiation.

OBJECTIVE: To investigate the survival, integration, and differentiation of mouse retinal progenitor cells after transplantation to the subretinal space of adult pigs. METHODS: Green fluorescent protein-positive (GFP+) murine retinal progenitor cells were transplanted subretinally as single cells, spheres, or biodegradable polymer-progenitor composites into 24 nonimmunosuppressed adult pigs. Of these, 14 pigs received laser lesions (n = 11) or outer retinal scraping injury (n = 3). Recipients were killed at 30 minutes to 5 weeks after grafting. RESULTS: The GFP+ murine retinal progenitor cells survived well for up to 14 days after transplantation to the pig retina. After 5 weeks, fewer GFP+ cells were found. In the pigs that received laser treatment before grafting of cell suspension, GFP+ cells integrated into the retinal pigment epithelium and all layers of the retina. The GFP+ cells exhibited morphologic evidence of differentiation into mature retinal neurons, although evaluation of marker expression found only nestin and glial fibrillary acidic protein colocalization. In noninjured pigs, cells mainly integrated into the retinal pigment epithelium. In pigs that received composites, cells appeared to mature and extended processes through pores in the polymer matrix. CONCLUSIONS: Retinal progenitor cell xenografts survive for a sufficiently long period to integrate into areas of injury and exhibit morphologic differentiation. By 5 weeks, survival diminishes. Biodegradable polymers may be useful for transplanting retinal progenitor cells in a structurally organized manner. Clinical Relevance Central nervous system (CNS) diseases may cause long-term disabilities. Substantial tissue destruction can be sustained by the complex structures of the brain, spinal cord, or retina without loss of life, yet the lack of effective CNS regeneration frequently results in disruption of activities of daily living and marked degradation in quality of life. It has become clear that an enormous potential for repair is present within the mammalian CNS. The challenge is to harness this potential to treat disease. Transplantation of neuronal tissue to the CNS represents a promising, albeit challenging, approach to the replacement of neurons lost owing to injury or disease.

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A technique for medial canthal fixation using resorbable poly-L-lactic acid-polyglycolic acid fixation kit.

Achieving secure bony fixation of medial canthus is a challenge. We used a resorbable poly-L-lactic acid-polyglycolic acid screw (LactoSorb office fixation kit) in 5 cases: 2 with traumatic medial canthal dystopia, 1 with scleroderma and orbital fat atrophy causing malapposition of the medial canthus to globe, and 2 with invasive medial canthal tumors necessitating subtotal medial orbital exenteration. The resorbable screw with preplaced suture was drilled into the medial orbital wall, using a handheld self-drilling tap. The preplaced suture was used to anchor the medial canthus. We achieved satisfactory canthal position in all 5 cases. There were no complications in 4 cases during a mean +/- SD follow-up of 11.3 +/- 6 months; however, the scleroderma case developed wound dehiscence 6 weeks after surgery. The LactoSorb kit is a safe and effective technique to achieve bony medial canthal fixation in carefully selected cases.

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Laryngotracheal reconstruction in canines: fixation of autologous costochondral grafts using polylactic and polyglycolic acid miniplates.

OBJECTIVE: To examine the feasibility of a new method of laryngotracheal reconstruction (LTR) that uses a bioabsorbable plating system consisting of polylactic and polyglycolic acid and provides some advantages over currently used methods. DESIGN AND INTERVENTIONS: Anterior subglottic stenosis was created in 10 beagles that then underwent LTR using an autologous costochondral graft. External laryngotracheal framework and cartilage grafts were secured using a sheet and screws made from a copolymer composed of polylactic and polyglycolic acid. Animals were humanely killed at 40, 60, and 90 days, and specimens were submitted for pathological examination. Histologic analysis included evaluation for inflammatory reaction, polylactic and polyglycolic acid incorporation into cartilage, cartilage necrosis, cartilage remodeling, and graft epithelialization. RESULTS: All animals underwent LTR after creation of a subglottic stenosis without episodes of airway compromise. After LTR, all airways were returned to prestenosis diameter without significant complication, and all animals were immediately extubated after surgery without difficulty. After the animals were killed, distraction of the stenotic cricoid area was demonstrated in 100% of the cases. Significant necrosis was noted in 2 of 10 grafts grossly; however, histologic analysis demonstrated significant areas of viable cartilage, areas of cartilage remodeling, and good epithelialization despite graft necrosis. Complete epithelialization of grafts was noted in the other 8 specimens. CONCLUSIONS: Using a canine model, we demonstrated a bioabsorbable plating system that offers an effective method for LTR. This model has the advantages of providing external support to the operated laryngeal and tracheal framework, elimination of the difficulties of suture placement, and potential future failure while offering rigid external fixation of a cartilage graft.

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Ligament graft initial fixation strength using biodegradable interference screws.

The objective of this study was to evaluate the initial fixation strength of three types of biodegradable interference screws [an Endo Fix, 7 x 25 mm polyglycolic acid, non-self-tapping (Acufex); a biodegradable interference screw, 7 x 23 mm poly-L-lactic acid, self-tapping (Arthrex); a Bioscrew, 7 x 25 mm poly-L-lactic acid, self-tapping (Linvatec)] in comparison to a titanium interference screw (Linvatec, 7 x 25 mm) in anterior cruciate ligament reconstruction using a bone-patellar tendon-bone graft. Porcine lower limbs were used. To control for specimen related bias, bone mineral density of each tibia was measured. All specimens were loaded to failure. Failure mode was determined by visual analysis. The maximum load to failure [mean (SD)] was 785 (87) N (titanium screw), 555 (60) N (Acufex), 592 (211) N (Arthrex), and 844 N (Linvatec). The primary fixation strength of the titanium screw and the Linvatec screw was significantly higher (p < 0.05) than the primary fixation strength of the Arthrex screw and the Acufex screw. There was no difference in bone mineral density between the groups. With respect to primary fixation strength, all biodegradable screws were strong enough to allow accelerated rehabilitation. From this point of view the biodegradable screws may be a reasonable alternative to titanium interference screws.

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Development of a bioabsorbable suture anchor.

In this article, the design and properties of a new bioabsorbable suture anchor (SmartAnchor(trade mark)) are described and its properties are compared with those of some commercial anchors. Two comparative experiments were carried out in order to measure (1) the breaking force of suture/anchor attachment for SmartAnchor, MitekGII, and for Ogden anchors; and (2) the fixation force of the following anchors and tacks: SmartAnchor, MitekGII, BankartTack, and Suretac. The average suture/anchor attachment breaking force of SmartAnchor (204, 9 N) was 32% higher in comparison to MitekGII (155, 6 N) and 84% higher in comparison to the Ogden anchor (111, 4). The mean fixation force of the SmartAnchor (195, 5 N) was 40% higher than that of MitekGII (139, 2 N), but the T-test showed no statistical differences between MitekGII and SmartAnchor (p = 0.05). Both tested tacks behaved very similarly in this test. The average fixation force (pull-out force) for both tacks was about 210 N. Therefore, it is evident that the bioabsorbable SmartAnchor has a high enough initial mechanical performance for clinical investigation.

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In vitro growth and activity of primary chondrocytes on a resorbable polylactide three-dimensional scaffold.

Sheep articular chondrocytes were cultured for 3, 6, and 9 weeks on a three-dimensional porous scaffold from poly(L/DL-lactide) 80/20%. Cell growth and activity was estimated from the amount of proteoglycans attached to the polylactide scaffold and the amounts of DNA and proteins measured in the cell lysate. Cell morphology was assessed from scanning electron microscopy. Histochemical staining of proteoglycans present in the sponge was used to visualize the chondrocyte ingrowth in the scaffold. The amounts of DNA, proteins, and proteoglycans increased with time of culturing. Chondrocytes on the polylactide scaffold maintained their round shape. The cell ingrowth into the sponge progressed with time of culturing and proceeded from the upper surface of the sponge toward its lower surface. At 9 weeks, the chondrocytes filled the whole scaffold and reached the opposite side of the sponge. The proteoglycans network was, however, more dense at the upper half of the scaffold.

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An absorbable pinned-ring device for microvascular anastomosis of vein grafts: experimental studies.

In the rabbit, posterior facial vein segments were grafted to the femoral arteries using either conventional suture technique or a mechanical absorbable pinned-ring device. The purpose of this study was to compare patency rates and anastomotic times for the two different methods. The anastomoses were evaluated macroscopically and using light and scanning electron microscopy. The grafts anastomosed with the absorbable rings exhibited 100% patency, while only 83% of the sutured grafts were patent. The mean anastomotic time using the mechanical pinned-ring device was 18.1 min (range 9.8-30 min). The conventionally sutured anastomoses were completed in a mean time of 60 min (range 50-75 min). The experiment has confirmed that the absorbable pinned-ring device provides a safe and fast way to perform microvascular anastomosis.

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Assessment of tissue blood flow following small artery welding with an intraluminal dissolvable stent.

Using the technique of radioactive 51Cr-labeled biological microspheres, this study evaluated arterial blood flow following small vessel anastomosis by CO2 laser welding and a dissolvable stent in the lumen. A total of 30 Sprague-Dawley rats were divided into two groups. Group A: 11 rats had their femoral arteries ligated on one side. The contralateral side served as a control, with the artery transected and repaired using conventional microsuturing. Group B: 19 rats had their femoral arteries transected and repaired using CO2 laser welding and an intraluminal dissolvable stent technique. The contralateral side was again used as a control using conventional microsuturing. At 1 hr postoperatively, 51Cr-labeled biological microspheres were injected centripetally into the left common carotid artery and the legs and thighs immediately harvested for measurement of radioactivity. All repaired arteries were patent (30/30 in the microsuturing group and 19/19 in the stented welding group), with no detectable stenosis or dilation at the repaired site. Statistical analysis showed that tissue radioactivity (cpm/g) in the ligated group (3,972 +/- 384 in thighs and 3,142 +/- 742 in legs) was significantly lower than in the microsuturing group (7,132 +/- 1,723 in thighs and 6,557 +/- 1,469 in legs) (P < 0.01). In the ligated group, a significant reduction of blood flow was seen in the legs when compared with the thighs (P < 0.05). There was no significant difference in radioactivity when comparing the microsuturing control with the stented welding group, in both thighs (7,064 +/- 2,599 and 7,006 +/- 2,406, respectively; P > 0.05) and legs (6,386 +/- 1,703 and 6,288 +/- 1,757, respectively; P > 0.05). This study provided evidence that the dissolvable stent placed intraluminally does not impair blood circulation and that when coupled with CO2 laser welding offers a high-quality alternative to conventional small vessel anastomosis.

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Neuronal survival using a resorbable synthetic conduit as an alternative to primary nerve repair.

Clinically optimal situations for primary nerve repair are rarely observed. Crushed nerve ends result in either suboptimal repair or a need for nerve grafting. Functional results after nerve surgery are relatively poor, including major sensory deficits, which may be due to the death of primary sensory neurons that follows the nerve injury. The aim of this study was to determine if using polyhydroxybutyrate (PHB), a resorbable nerve conduit, could be an alternative to primary nerve repair in reducing loss of neurons. The superficial radial nerves in 20 cats were sectioned bilaterally and primarily repaired microsurgically by the use of two different strategies; either wrapping the nerve ends in sheets of PHB or epineurally suturing of the nerve. After 6 or 12 months, the surviving neurons within the dorsal root ganglia [C5-T1] were counted. No statistically significant differences were found between the two methods. This may imply a future possibility of using PHB as a synthetic nerve graft in situations where suboptimal primary repair or nerve grafts are the alternatives.

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Functional assessment of sciatic nerve reconstruction: biodegradable poly (DLLA-epsilon-CL) nerve guides versus autologous nerve grafts.

The aim of this study was to compare functional nerve recovery after reconstruction with a biodegradable p(DLLA-epsilon-CL) nerve guide filled with modified denatured muscle tissue (MDMT), or an autologous nerve graft. We evaluated nerve recovery using walking track analysis (measurement of the sciatic function index [SFI]) and electrostimulation tests. Functional nerve recovery after reconstruction with a biodegradable p(DLLA-epsilon-CL) nerve guide filled with MDMT was faster when compared with nerve reconstruction using an autologous nerve graft. We conclude that in case of a short nerve gap in the rat, reconstruction can best be carried out using a p(DLLA-epsilon-CL) biodegradable nerve guide filled with MDMT.

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Periadventitial lacZ gene transfer to pig carotid arteries using a biodegradable collagen collar or a wrap of collagen sheet with adenoviruses and plasmid-liposome complexes.

BACKGROUND: Periadventitial gene therapy is a promising alternative for the treatment of stenosis, vessel wall thickening and other complications in vascular surgery. METHODS: We compared lacZ gene transfer efficiency of DOTMA: DOPE (1:1 w/w) plasmid/liposome complexes and adenoviruses in pig carotid arteries using perivascular delivery with either a collagen collar or a wrap of collagen sheet. Safety of the gene transfer was studied by clinical chemistry, tissue pathology and PCR analysis of lung, liver, kidney, spleen, skeletal muscle and gonads. RESULTS: Gene transfer efficiency using the periadventitial collar was fourfold higher than using the collagen wrap with adenovirus at 7 days (10.22 +/- 2.96 vs 2.78 +/- 1.28 positive cells/mm2; p = 0.18) and 4.3-fold at 14 days (13.46 +/- 3.49 vs 3.11 +/- 0.88 positive cells/mm2; p = 0.03). Gene transfer efficiency at 7 days with adenovirus was fivefold higher than with the plasmid/liposome complexes both using the collar (10.22 +/- 2.96 vs 2.07 +/- 0.95 positive cells/mm2; p = 0.01) and the collagen wrap (2.78 +/- 1.28 vs 0.45 +/- 0.35 positive cells/mm2; p = 0.03). No lacZ activity was detected in plasmid/liposome transfected arteries at 14 days. In spite of the local gene delivery methods a moderate systemic distribution of the transgene was detected in the major organs by PCR analysis. CONCLUSIONS: This study shows that: (i) adenovirus delivered with the periadventitial collar or the collagen wrap is well tolerated and may become an efficient new tool in vascular gene therapy, and (ii) gene transfer vector delivered in the periadventitial collar reaches the target tissue more efficiently than the vector in the collagen wrap.

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Evaluation of calcium phosphates and experimental calcium phosphate bone cements using osteogenic cultures.

In this study, rat bone marrow cells (RBM) were used to evaluate two biodegradable calcium phosphate bone cements and bioactive calcium phosphate ceramics. The substances investigated were: two novel calcium phosphate cements, Biocement F and Biocement H, tricalcium phosphate (TCP), surface-modified alpha-tricalcium phosphate [TCP (s)] and a rapid resorbable calcium phosphate ceramic consisting of CaKPO(4) (sample code R5). RBM cells were cultured on disc-shaped test substrates for 14 days. The culture medium was changed daily and also examined for calcium, phosphate, and potassium concentrations. Specimens were evaluated using light microscopy, and morphometry of the cell-covered substrate surface, scanning electron microscopy, and energy dispersive X-ray analysis and morphometry of the cell-covered substrate surface. Areas of mineralization were identified by tetracyline labeling. Except for R 5, rat bone-marrow cells attached and grew on all substrate surfaces. Of the different calcium phosphate materials tested, TCP and TCP (s) facilitated osteoblast growth and extracellular matrix elaboration to the highest degree, followed by Biocements H and F. The inhibition of cell growth encountered with R 5 seems to be related to its high phosphate and potassium ion release.

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Durability of sodium sulfate-treated polylysine-alginate microcapsules.

Chelated hollow microcapsules are unstable under in vitro conditions because of their hygroscopic nature. Nongel inducing cations, such as Na+, stabilize the outer membrane of the alginate-polylysine-alginate microcapsules leading to more stable beads. We made different batches of empty capsules with a mean +/- SEM diameter of 607+/-11 microns, and found that within 1 week of incubating these capsules in normal saline at 37 degrees C, they increased to 718+/-10 microns (p < 0.05, n = 5). In initial experiments, we made different batches of capsules and divided them into two groups. One group was left untreated (control) whereas the other was treated with 6 mM Na2SO4 for 30 min, before incubation in saline at 37 degrees C. Control capsules increased in weight and size, before beginning to melt in less than 1 week. In contrast, treated capsules rapidly lost weight and remained intact during 1 month of follow-up. In perifusion experiments, we found no deleterious effect of sodium sulfate treatment on the function of islets enclosed in the capsules.

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Sensitizer contained in heat-decomposed dye.

Recently a new resorbable P(LA/CL) monofilament suture made of L-lactide and epsilon-caprolactone was developed. The sensitization test was carried out using a guinea pig maximization test according to the Japanese Guidelines. As a result of this test, it was revealed that the methanol extract of P(LA/CL) suture contains a skin sensitizer. It was suggested that the D&C Violet No. 2 contained in P(LA/CL) sutures is decomposed during the melt-spinning process and that the decomposed dye induces skin sensitization. To characterize the sensitizer (the decomposed dye) it was separated and collected by HPLC. To determine the molecular formula of the sensitizer, MS, IR, and NMR spectra were obtained. The molecular weight of the sensitizer was estimated as 240 by measuring the MS. Considering the chemical structure of the dye and the molecular weights, it was determined that the sensitizer was 1,4-dihydroxyanthraquinone (quinizarin). The D&C Violet No. 2 contained in P(LA/CL) sutures was decomposed by the melt-spinning procedure to form quinizarin, one type of anthraquinone dye, and the sensitizer was identified to be, indeed, quinizarin. To evaluate the sensitizing potential of quinizarin, we tested skin sensitization using the maximization test method. Quinizarin induced skin sensitization in guinea pigs, and the minimum sensitizing concentration was approximately 100 ppm. The concentration of quinizarin contained in the P(LA/CL) suture was 1-5 ppm, a value that is lower than the minimum sensitizing concentration of quinizarin. This suggests that P(LA/CL) suture has a low risk with regard to contact dermatitis.

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Spectroscopic study on the enzymatic degradation of a biodegradable composite periodontal membrane.

The enzymatic in vitro degradation of a commercial biodegradable hydroxyapatite (HA)-polymer (poly(epsilon-caprolactone)-poly(oxyethylene)(POE)-poly(epsilon-caprolactone) block copolymer) composite membrane was investigated by Raman and IR spectroscopies in two enzymatic solutions at 37 degrees C: esterase and alpha-chymotrypsin in saline phosphate buffer (SPB, pH 7.4). The degradation was found to be faster in the enzymatic medium than in SPB and alkaline solutions. The fastest degradation rate was observed in esterase solution. The trend of properly chosen Raman and IR intensity ratios was evaluated to go deeper inside the degradation mechanism: both polymeric and apatitic components were found to be involved in degradation. The former underwent preferential degradation of POE blocks, while HA is removed by the degradation medium faster than the polymer. Vibrational spectroscopy proved a valid tool for investigating the degradation of the membrane.

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