Prosthetic devices shaped as tubular chambers for the treatment of large diaphyseal defects by guided bone regeneration.

Guided tissue regeneration is based on the hypothesis that the different tissues have unequal abilities to penetrate a wounded area during the healing process. The use of a device acting as a chamber allows the growth of a particular tissue and prevents the ingrowth of other tissues which impair the healing process. At the same time the chamber protects and maintains in situ the intrinsic growth factors so that they may perform their specific activity. Guided tissue regeneration currently plays a well-recognized role mostly in dentistry and peripheral nerve surgery but interesting perspectives have also opened up in orthopedics. Considering the possibility of using guided bone regeneration in the repair of diaphyseal bone defects, this updated survey highlights some critical points and pathways related to the state-of-the-art of this promising procedure, focusing particularly on the properties of the material to make the tubular chamber, the use of osteopromotive factors and the most appropriate animal model to be used for the experimental evaluation.

Osseointegration of sandblasted or anodised hydrothermally-treated titanium implants: mechanical, histomorphometric and bone hardness measurements.

The improvement of the implant-bone interface is still an open problem in the long-term mechanical stability of cementless fixed implants. Mechanical, histomorphometric and bone hardness measurements were performed in sheep femoral cortical bone implants at 8 and 12 weeks from surgery to compare in vivo the osseointegration of titanium screws (psi 3.5 mm x 7 mm length) with two different surface treatments: sandblasting with 70-100 microm HA followed by acid etching with HNO3 (Group A) and Ca-P anodization followed by a hydrothermal treatment (Group B). No significant differences were found for maximum push-out force and interfacial strength between groups at both experimental times. No significant difference was observed for Bone Ingrowth between groups at both experimental times, while the Affinity Index of Group B was significantly higher (7.5%, p<0.05) and lower (10.2%, p<0.05) than that of Group A at 8 and 12 weeks, respectively. Finally, a significant increase in bone microhardness measured within 200 microm from the interface and inside the thread depth of Group A was observed between the two experimental times (p<0.05). In conclusion, present findings show that osseointegration may be accelerated by adequate surface roughness and bioactive ceramic coating such as current tested treatments which enhance bone interlocking and mineralization.

Laser stimulation on bone defect healing: an in vitro study.

The aim of this in vitro study was to evaluate whether low-power laser (LPL) stimulation can accelerate bone healing. Bone defects of a standard area were created in the distal epiphysis of 12 femora explanted from six rats, and they were cultured in BGJb medium for 21 days. Six defects were treated daily with Ga-Al-As, 780 nm LPL for 10 consecutive days (lased group, LG), while the remainder were sham-treated (control group, CG). Alkaline phosphatase/total protein (ALP/TP), calcium (Ca), and nitric oxide (NO) were tested on days 7, 14 and 21 to monitor the metabolism of cultured bone. The percentage of healing of the defect area was determined by histomorphometric analysis. After 21 days significant increases were observed in ALP/TP in LG versus CG (p<0.001), in NO in the LG versus CG ( p<0.0005) and in Ca in CG versus LG ( p<0.001). The healing rate of the defect area in the LG was higher than in the CG ( p=0.007). These in vitro results suggest that Ga-Al-As LPL treatment may play a positive role in bone defect healing.

Low-power diode laser stimulation of surgical osteochondral defects: results after 24 weeks.

The purpose of this study was to evaluate osteochondral lesions of the knee, treated intraoperatively with low-power laser stimulation, and assess results at 24 weeks. Surgery was performed under general anesthesia on six rabbits; a bilateral osteochondral lesion was created in the femoral medial condyles with a drill. All of the left lesions underwent immediate stimulation using the diode Ga-Al-As laser (780nm), whereas the right knees were left untreated as control group. After 24 weeks, the explants from the femoral condyles, either treated employing laser energy or left untreated, were examined histomorphometrically. Results obtained on the lased condyles showed good cell morphology and a regular aspect of the repaired osteocartilaginous tissue.

Laser biostimulation of cartilage: in vitro evaluation.

An in vitro study was performed to evaluate the laser biostimulation effect on cartilage using a new gallium-aluminium-arsenic diode laser. Chondrocyte cultures were derived from rabbit and human cartilage. These cells were exposed to laser treatment for 5 days, using the following parameters: 300 joules, 1 watt, 100 (treatment A) or 300 (treatment B) hertz, pulsating emission for 10 minutes, under a sterile laminar flow. Control cultures (no treatment) received the same treatment with the laser device off. Cell viability was measured by MTT assay at the end of the laser treatment and then after 5 days. Neither rabbit nor human cultured chondrocytes showed any damage under a light microscope and immunostaining control following laser treatment. The MTT test results indicated a positive biostimulation effect on cell proliferation with respect to the control group. The increase in viability of irradiated chondrocytes was maintained for five days following the end of the laser treatment. The results obtained with the Ga-Al-As diode laser using the above tested parameters for in vitro biostimulation of cartilage tissues provide a basis for a rational approach to the experimental and clinical use of this device.

Laser technology in orthopedics: preliminary study on low power laser therapy to improve the bone-biomaterial interface.

Low Power Laser (LPL) seems to enhance the healing of bone defects and fractures. The effect of LPL in other orthopedic areas such as osteointegration of implanted prosthetic bone devices is still unclear. In the present study, 12 rabbits were used to evaluate whether Ga-Al-As (780 nm) LPL stimulation has positive effects on osteointegration. Hydroxyapatite (HA) cylindrical nails were drilled into both distal femurs of rabbits. From postoperative day 1 and for 5 consecutive days, the left femura of all rabbits were given LPL treatment (Laser Group-LG) with the following parameters: 300 Joule/cm2, 1 Watt, 300 Hertz, pulsating emission, 10 minutes. The right femura were sham-treated (Control Group-CG). At 4 and 8 weeks after implantation, histologic and histomorphometric investigations evaluated bone-biomaterial-contact. Histomorphometry showed a higher degree of osteointegration at the HA-bone interface in the LG Group at 4 (p < 0.0005) and 8 weeks (p < 0.001). These preliminary positive results seem to support the hypothesis that LPL treatment can be considered a good tool to enhance the bone-implant interface in orthopedic surgery.

Assessment of low-power laser biostimulation on chondral lesions: an "in vivo" experimental study.

The purpose of this study was to evaluate whether intraoperative laser biostimulation can enhance healing of cartilaginous lesions of the knee. Surgery was performed on eighteen rabbits: a bilateral chondral lesion of 1.25 +/- 0.2 mm in length and 0.8 +/- 0.2 mm in width was created in the femoral medial condyle with a scalpel. The lesion in the left knee of each animal was treated intraoperatively using the diode Ga-Al-As 780nm. laser (300 Joules/cm2, 1 Watt, 300 Hertz, 10 minutes), while the right knee was left untreated, as control group. The animals were divided into three groups, A, B and C, according to the survival time after surgery, two, six and twelve weeks, respectively. The explants from the femoral condyles, both treated employing laser energy and left untreated, were examined histologically. Results showed a progressive filling with fibrous tissue of the cartilaginous lesion treated with laser irradiation, while no changes in the original lesion of the untreated group were observed at the end of the study. Maybe, in this experimental research, underexposure to laser irradiation was the cause for the absence of the necessary conditions for biostimulation.

Osteochondral lesion repair of the knee in the rabbit after low-power diode Ga-Al-As laser biostimulation: an experimental study.

The purpose of this study was to evaluate whether low-power laser biostimulation of the osteo-chondral lesions of the knee could by itself reduce repair healing time. Surgery was performed on eighteen rabbits; a bilateral osteo-chondral lesion of 2.5mm in diameter and 2mm depth was created in the femoral medial condyle with a drill. The left knee of each animal was treated intraoperatively using the diode Ga-Al-As laser (780nm) with the following parameters: 300 Joules/cm2, 1 Watts, 300 Hertz, 10 minutes; the right knee was left untreated, as control group. The animals were divided into three groups, A, B and C, according to the survival time after surgery, two, six and twelve weeks, respectively. The explants from the femoral condyles, either treated employing laser energy or left untreated, were examined histomorphometrically. Results after laser treatment showed faster healing of the lesion at week 2 (p=0.043) and an overall improvement in cellular morphology (p=0.044), while a more regular aspect of the osteocartilaginous tissue was observed at week 12 (p=0.004). A relationship between laser biostimulation properties and healing of the osteo-chondral defect has been demonstrated.

Biostimulation of human chondrocytes with Ga-Al-As diode laser: 'in vitro' research.

The aim of this study was to verify the effects of laser therapy performed with Ga-Al-As Diode Lasers (780 nm, 2500 mW) on human cartilage cells in vitro. The cartilage sample used for the biostimulation treatment was taken from the right knee of a 19-year-old patient. After the chondrocytes were isolated and suspended for cultivation, the cultures were incubated for 10 days. The cultures were divided into four groups. Groups I, II, III were subject to biostimulation with the following laser parameters: 300 J, 1 W, 100 Hz, 10 min. exposure, pulsating emission; 300 J, 1 W, 300 Hz, 10 min. exposure, pulsating emission; and 300 J, 1 W, 500 Hz, 10 min. exposure, pulsating emission, respectively. Group IV did not receive any treatment. The laser biostimulation was conducted for five consecutive days. At the end of the treatment, the Calcium, Alkaline Phosphate, MTT tests and proteoglycan were performed to assess cell metabolism and toxicity level. The data showed good results in terms of cell viability and levels of Ca and Alkaline Phosphate in the groups treated with laser biostimulation compared to the untreated group. The results obtained confirm our previous positive in vitro results that the Ga-Al-As Laser provides biostimulation without cell damage.

The effect of osteopenia on the osteointegration of different biomaterials: histomorphometric study in rats.

The osteointegration of Hydroxyapatite (HA), Titanium (Ti-6Al-4V: Ti), Zirconia (ZrO2), Alumina (Al2O3) and 2 biological glasses (AP40 and RKKP) was comparatively investigated in normal and osteopenic rats by means of histomorphometry. Thirty-six Sprague Dawley female rats were left intact (Group C) while 36 were ovariectomized (Group OVX). Group C and OVX were further divided into 6 subgroups. After 16 weeks all animals were submitted to the femoral implant of nails made of the above-mentioned materials. Eight weeks after implantation the animals were euthanized, the femurs were harvested for histomorphometric analysis. The data showed that: (1) all the tested materials were biocompatible in vitro; (2) no significant differences existed in Affinity Index (AI) of Group C; and (3) results from paired comparison applied to the AI showed significant differences among the Groups C and OVX. The AI did not significantly change among intact groups, while it significantly decreased when some materials were implanted in OVX subgroups (AP40, ZrO2 and Ti-6Al-4V: p < 0.0005, p < 0.05 and p < 0.01). It is confirmed that bone mineral density is a strong predictor of the osteointegration of an orthopedic implant and that the use of pathological animal models is necessary to completely characterize biomaterials.

Effects of essential amino acids and lactose on bony fractures and defects in rabbits: a preliminary histomorphometric study.

An experimental study was performed in order to test the possibility of improving bone repair with the administration of a drug (Calciofix, Farmaceutici Damor SpA, Naples, Italy) containing essential amino acids and lactose. Fifty rabbits were submitted to an open transversal fracture of the left fibula and to a right femoral condyle defect. They were left untreated or treated daily with the drug orally and were divided into subgroups depending on the experimental time: 15, 30, 40, 50, 60 days. Histomorphometric data showed a significantly faster healing rate in treated animals compared with untreated ones. Firstly, on day 30 there was a significantly larger amount of cartilage in the control bone callus (P < 0.01). On day 50 a significant difference existed between trabecular and lacunar percentages in the two subgroups (P < 0.0005). At 60 days no significant differences were observed, but bony trabeculae had become more oriented parallel to the long axis of the bone in treated animals. Secondly, after 15 days the defect area was significantly smaller in treated animals than in the untreated ones (P < 0.01). At 30 and 40 days, respectively, significant differences existed between the two subgroups in connective tissue and mature bone percentages (P < 0.01 and P < 0.001). Our results seem to demonstrate that the drug significantly accelerates the rate of bone formation in fractures and bone defects in rabbits.

[Cartilage cell stimulation with low-power laser: experimental assessment]. / Stimolazione delle cellule cartilaginee con low-power laser: valutazione sperimentale.

The aim of this study was to verify the effects of laser therapy performed with Ga-Al-As diode laser (780 nm, 2500 mW) on cartilage cells in vitro. The cartilage sample used for biostimulation was taken from the knee of an adult patient. The cultures were divided into four groups: Groups I, II, III were subjected to biostimulation with different laser parameters; Group IV did not received any treatment. The laser biostimulation was conducted for five consecutive days. At the end of the treatment, cell count and MTT tests were performed to assess cell metabolism. The data showed good results in terms of cell viability in the groups treated with laser biostimulation compared to the untreated group. The results obtained with the use of this new low-power diode laser Ga-Al-As device in the biostimulation of the cartilage tissue, permits us to consider the use of this device clinically.

[Trauma of the peripheral nervous system: experimental assessments with guided tissue regeneration]. / Lesioni traumatiche del Sistema Nervoso Periferico: valutazioni sperimentali sulla rigenerazione tessutale guidata.

Guided tissue regeneration open interesting perspectives in reconstructive surgery of peripheral nerves. Artificial conduits for nerve repair can be obtained with biodegradable polymers. Lactic and caproic acid copolimers and poliphosphazenes are biocompatible materials and have a slow reabsorption rate. Two types of conduits obtained with Poli[L-lactide-co-6-caprolactone] and poli [bis (etilalanate) phosphazene] were evaluAted as guides for nerve regeneration in an experimental model on two groups of six Wistar rats. Under general anesthesia and with microsurgical technique, the ischiatic nerve was bilaterally isolated. On the right side a segment of the nerve was removed to create a 10 mm gap. The defect was then repaired using the conduit. On the controlateral limb after the creation of the same defect, the nerve continuity was restored using as an autograft the segment removed from the right side. Control were performed at 30, 90, 180 days and consisted in histological and electron microscopy investigations. They showed the gradual degradation of both the conduits without signs of local toxicity. The regeneration of the nerve fibers in the lumen was not significantly different from that observed in the autologous grafts. Both the conduits may be considered effective for guided nerve regeneration, but polyphosphazenes allow the possibility of use the polymer as a carrier for neurite-promoting factors.

In vitro experimental research of rabbit condrocytes biostimulation with diode laser Ga-Al-As: a preliminary study.

The scope of our study was to verify the effects of a new diode laser device with active material composed of Gallium, Aluminum and Arsenic (Ga-Al-As) configured as MOCVD (780 nm., 3000 mW) for the biostimulation of the cartilage cells in vitro. The condrocytes cells, withdrawn from the cartilage of the medial condyle of the femur of the rabbit, were cultivated, incubated and subject to biostimulation treatment with the laser. The condrocytes cells were placed in 24 Petri dishes at the concentration of 0.25 x 10(5)/ml and divided into 4 groups: 3 group (I, II, III) were treated with the laser and the fourth group (IV) was used as the control group. At the end of the treatment, all four groups, were evaluated with a MTT test and a cell count of the condrocytes cells. Group III (300 J, 1 Watt, 300 Hz, 10' of exposure time with a pulsating emission) provided the best results in terms of cell viability (MTT test) and for the number of cells found in the dishes when compared to the other treated groups and the control group. The results obtained with the use of this new diode laser Ga-Al-As device in the biostimulation of the cartilage tissue, permits us to consider the use of this device clinically.

Muscular trauma treated with a ga-Al-as diode laser: in vivo experimental study.

The aim of the study was to verify in an experimental model the effects of laser therapy performed with Ga-Al-As diode lasers (780 nm, 2500 mW) on traumatised muscles. Forty adult New Zealand male rabbits were divided into four groups (A, B, C and D) of ten animals each. Each group of animals was further divided into two subgroups of five animals each. The animals were submitted to muscular trauma for 7 min by clamping the posterior muscles of the left thigh under general anaesthesia. Four days later, the rabbits in the B1, B2, C1, C2, D1 and D2 subgroups started daily laser therapy. The parameters utilised were: 150 J/cm(2) energy density, 3 W, 50 Hz in group B; 250 J/cm(2), 3 W, 100 Hz in group C; and 800 J/cm(2), 3 W, 0 Hz (continuous output) in group D. The animals in subgroups A1 and A2 were used as untreated controls and allowed to heal spontaneously. In order to prepare samples for histological, histochemical and histomorphometrical studies, dissection of the posterior muscle of the thigh was performed under general anaesthesia and before sacrifice, after five days of laser therapy in the subgroups B1, C1 and D1 and after ten days of laser therapy in subgroups B2, C2 and D2. The samples of untreated subgroups A1 and A2 were subjected to the same procedure and at the same times as the corresponding laser-treated groups. The following parameters were analysed on muscular samples: qualitative histological aspect (lactate dehydrogenase (LDH), cytochrome oxidase, acid phosphatase and alkaline phosphatase concentration with histoenzymatic methods) and quantitative histomorphometric evaluation of muscular damage and tissue repair. Blood samples were drawn from each subgroup before the trauma and again before sacrifice to measure the creatine phosphokinase (CK) and LDH levels. The results obtained in the tables are shown. Analysis of the results showed a better qualitative and quantitative healing process in traumatised muscles treated with Ga-Al-As diode laser therapy than in spontaneously healed ones. The results obtained with laser therapy were confirmed as haematic, histoenzymatic and histomorphometric values. According to these results, there is a positive relationship between the biostimulation properties of the laser and the healing of traumatised muscular tissue.

Biomaterials for orthopedic surgery in osteoporotic bone: a comparative study in osteopenic rats.

UNLABELLED: To evaluate orthopedic devices in pathological bone, an experimental study was performed by implanting Titanium (Ti) and Hydroxyapatite (HA) rods in normal and osteopenic bone. Twenty-four rats were used: 12 were left intact ( CONTROL: C) while the other 12 were ovariectomized (OVX). After 4 months all the animals were submitted to the implant of Ti or HA in the left femoral condyle (Ti-C, HA-C, Ti-OVX, HA-OVX). Two months later the animals were sacrificed for histomorphometric, ultrastructural and microanalytic studies. Our results show a significant difference between the Affinity Index (A.I.) of HA-C and Ti-C (77.0 +/- 7.4 vs 61.2 +/- 9.7) (p < 0.05). No significant differences were observed between the osteointegration of Ti-C and Ti-OVX (61.2 +/- 9.7 vs 48.2 +/- 6.7). Significant differences also exist between the osteointegration of HA-C and HA-OVX (77.0 +/- 7.4 vs 57.6 +/- 11.5) (p < 0.01). Microanalysis shows some modifications in Sulphur (S) concentration at the bone/biomaterial interface of the Ti-OVX group. Therefore our results confirmed the importance of biomaterials characteristics and of bone quality in osteointegration processes.

[Role of microvascular free flaps in the treatment of amputation stumps]. / Ruolo dei lembi liberi microvascolari nel trattamento dei monconi di amputazione degli arti.

The authors report the importance of plastic surgery in rehabilitation of the amputated stump. After having referred the tight dependence between amputated stump and prosthesis, they underline the importance of a trophic and painless stump characterized by a satisfactory "useful length". They report two cases in which these priorities have been satisfied by using latissimus dorsi free flap. The authors believe that better rehabilitative results can be achieved by applying the most recent techniques utilized in plastic surgery and particularly microvascular free flaps.

[Experimental orthopedic surgery: the practical aspects and management]. / Chirurgia sperimentale ortopedica: aspetti pratici e gestionali.

The funds to grant for a scientific research project are more and more interesting public and private administrations. A quantitative analysis of experimental research prices in all its phases is mandatory for an optimization process. The aim of this paper is to define practical and economical aspects of the experimental 'in vivo' models designed for the validation of biomaterials, with particular respect to the managerial bookkeeping of consumer goods, based on the experience of our Institute. Some tables were realized in order to quantify the resources needed to perform experimental 'in vivo' models. These tables represent a reliable tool for a continuous monitoring of managerial costs for the current year and for an accurate budget planning for the future years considering the experimental projects in progress and the planned researches. A business organization of public research facilities may lead to an optimization of costs and an easier national and international funds achievement increasing, also, the partnership with private appointers.

[The osseointegration process: a still open chapter in experimental and clinical research]. / Il processo dell'osteointegrazione: un capitolo ancora aperto della ricerca sperimentale e clinica.

The osseointegration of biomaterials for dental and orthopaedic use is a still open topic in experimental and clinical research. Some aspects of this complex mechanism are not completely research. Some aspects of this complex mechanism are not completely explained yet. These reasons make the process of osseointegration a topical subject both in clinical and experimental view points. The authors describe how this complex event has not been studied with standard investigation and report also most of present research lines on the basis of their experience. A particular attention is paid to some factors related to both biomaterial and implant site, which can influence significantly the process of osseointegration.

[Evaluation of experimental data obtained using new-generation CO2 laser in surgery]. / Valutazione dei dati sperimentali ottenuti con l'impiego di un laser CO2 di nuova generazione in chirurgia.

In order to study the interaction between the laser and biological tissues, we realized an experimental "in vivo" model using 12 Wistar male adult rats (mean b.w. 300 gr.). On the animals, during general anesthesia and after an accurate shearing of the back, we performed a cutaneous lozenge in order to value the characteristics and the possibilities of a last generation laser. It concerns of a CO2 laser (EASY LASER SP5, CLASS IV F.D.A.) with the possibility of employing of different variables. During this study were evaluated the most interesting variables: frequency, power and duty cycle. Among the variables we identified the frequency of the application range of the superpulse effect and the selective photothermolysis. The histological and morphological studies performed on the cutaneous specimens after laser treatment, showed that the correct application of this kind of laser can be an effective help for the surgeon during clinical practice.