Long-term Insights: Histopathological Assessment in Polyurethane Implant Capsules up to 24 Years.

BACKGROUND: Polyurethane (PU)-coated breast implants are known for their strong integration into breast tissue and the formation of capsules around them. However, capsular contracture can pose both aesthetic and clinical challenges. OBJECTIVES: To analyze the biological and morphological characteristics of the capsular tissue surrounding PU-coated implants, irrespective of their contracture status, and to assess their potential suitability as a flap in revision breast surgery for capsular contracture. METHODS: A total of 23 tissue samples were harvested from the capsules surrounding PU-coated breast implants in 12 female patients during replacement or revision surgery. We evaluated collagen abundance, cellular and vascular density, inflammation, collagen band types and alignment, synovial metaplasia, capsule thickness, and the expression of inflammatory biomarkers and myofibroblasts using immunohistochemical techniques. Scanning electron microscopy was used to assess implant surface characteristics over time. RESULTS: We found a significant association of capsule contraction with longer implantation durations and greater implant surface roughness (p = 0.018 and p = 0.033, respectively). Synovial metaplasia was significantly more frequent in noncontracted capsules (p = 0.0049). Both capsule types consisted of paucicellular, type I collagen-rich compact fibrous tissue with low vascularization. There was a marked reduction in inflammatory cells within the foreign body granuloma. The expression of inflammatory biomarkers in the capsular tissue was negligible. CONCLUSIONS: Given the reduced levels of inflammatory and vascular components within the dense, fibrous capsular tissue, we consider them to be viable alternatives for use as capsular flaps in revision surgery. This strategy has the potential to mimic the reconstruction achieved with acellular dermal matrix.

Correlation Between Implant Positioning and Functional Outcomes in Partial Shoulder Resurfacing.

Objective The present study aimed to correlate functional outcomes and implant positioning in a case series of partial shoulder resurfacing arthroplasties. Methods A total of 25 patients were assessed for range of motion, functional outcome per the University of California at Los Angeles (UCLA) score and radiographic findings. Pre- and postoperative data were compared. In addition, patients were grouped according to the cervical-diaphyseal angle (CDA) determined by an anteroposterior radiography and to the retroversion angle (RVA) determined by an axillary radiography. A CDA from 130° to 140° and a RVA from 20° to 40° consisted in ideal positioning (anatomical standard). Data were analyzed using the Wilcoxon signed-rank test, analysis of variance (ANOVA) followed by the Kruskal-Wallis test or the Mann-Whitney test as appropriate. Results The mean follow-up time was 48.3 months (12 to 67 months). The postoperative functional score (31.5) was higher than the preoperative score (15.5) ( p < 0.001). In 6 patients, the implant was in anatomical positioning, while implant positioning was considered "nonstandard" in 19 subjects. Seven patients had a CDA < 130°, and 14 patients had a CDA ranging from 130° to 140°; in addition, the CDA was > 140° in 4 subjects. The RVA was up to 20° in 15 patients and ranged from 20° to 40° in 10 subjects. Using these criteria to group patients, the postoperative clinical-functional parameters were not statistically different from the preoperative findings ( p > 0.05). Conclusion Partial shoulder resurfacing results in significant postoperative functional recovery in patients with degenerative joint diseases. However, implant positioning assessed by CDA and RVA does not correlate with clinical-functional outcomes and, therefore, it is an inaccurate indicator of surgical success. Level of Evidence IV; Case Series.

Correlation Between Implant Positioning and Functional Outcomes in Partial Shoulder Resurfacing / Correlação entre posicionamento do implante das artroplastias parciais de recobrimento do ombro e os resultados funcionais

Abstract Objective The present study aimed to correlate functional outcomes and implant positioning in a case series of partial shoulder resurfacing arthroplasties. Methods A total of 25 patients were assessed for range of motion, functional outcome per the University of California at Los Angeles (UCLA) score and radiographic findings. Preand postoperative data were compared. In addition, patients were grouped according to the cervical-diaphyseal angle (CDA) determined by an anteroposterior radiography and to the retroversion angle (RVA) determined by an axillary radiography. A CDA from 130° to 140° and a RVA from 20° to 40° consisted in ideal positioning (anatomical standard). Data were analyzed using the Wilcoxon signed-rank test, analysis of variance (ANOVA) followed by the Kruskal-Wallis test or the Mann-Whitney test as appropriate. Results The mean follow-up time was 48.3 months (12 to 67 months). The postoperative functional score (31.5) was higher than the preoperative score (15.5) (p < 0.001). In 6 patients, the implant was in anatomical positioning, while implant positioning was considered "nonstandard" in 19 subjects. Seven patients had a CDA < 130°, and 14 patients had a CDA ranging from 130° to 140°; in addition, the CDA was > 140° in 4 subjects. The RVA was up to 20° in 15 patients and ranged from 20° to 40° in 10 subjects. Using these criteria to group patients, the postoperative clinical-functional parameters were not statistically different from the preoperative findings (p > 0.05). Conclusion Partial shoulder resurfacing results in significant postoperative functional recovery in patients with degenerative joint diseases. However, implant positioning assessed by CDA and RVA does not correlate with clinical-functional outcomes and, therefore, it is an inaccurate indicator of surgical success. Level of Evidence IV; Case Series.

Resumo Objetivo O objetivo do presente estudo é correlacionar os resultados funcionais de uma série de casos de artroplastias parciais de recobrimento do ombro com o posicionamento do implante. Métodos Um total de 25 pacientes foram avaliados em relação à amplitude de movimentos, à avaliação funcional pelo escore de Universidade da Califórnia Los Angeles (UCLA) e por análise radiográfica. Os dados pré- e pós-operatórios foram comparados. Adicionalmente, os pacientes foram agrupados quanto ao ângulo cérvico-diafisário (ACD) avaliado na radiografia em anteroposterior e quanto ao ângulo de retroversão (ARV) avaliado na radiografia em posição axilar. Foi considerado como posicionamento ideal (padrão anatômico) um ACD entre 130° e 140° e um ARV entre 20° e 40°. Os dados foram analisados pelo teste pareado de Wilcoxon, pela análise de variância (ANOVA, na sigla em inglês) seguida pelo pós-teste de Kruskal-Wallis ou pelo teste de Mann-Whitney, quando apropriado. Resultados O seguimento médio foi de 48,3 meses (12 a 67 meses). A avaliação funcional pós-operatória (31,5) foi melhor do que a pré-operatória (15,5) (p < 0,001). Seis pacientes apresentaram posicionamento anatômico do implante, enquanto 19 pacientes foram considerados "fora do padrão." Sete pacientes apresentaram um ACD < 130°, quatorze apresentaram um ACD entre 130° e 140°, e quatro apresentaram um ACD >140°. Quinze pacientes apresentaram um ARV ≤ 20°, e 10 entre 20° e 40°. Utilizando esses critérios para agrupar os pacientes, a comparação dos parâmetros da avaliação clínico-funcional pós-operatória não foi estatisticamente diferente (p > 0,05). Conclusão A artroplastia parcial de recobrimento do ombro oferece significativa recuperação funcional pós-operatória em pacientes com doenças degenerativas articulares. Entretanto, o posicionamento do implante avaliado pelos ACD e ARV não se correlaciona com o resultado clínico-funcional, sendo, portanto, uma medida imprecisa de sucesso da cirurgia. Nível de Evidência IV, Série de Casos.

In vivo evaluation of skin integration with ventricular assist device drivelines.

BACKGROUND: Ventricular assist device (VAD) driveline exit site infection is a common complication. 3D scaffolds manufactured with highly homogeneous pores via melt electro-writing (MEW) may generate an improved skin-driveline interface which permits cellular in-growth and creates a barrier to prevent bacterial migration along the driveline tissue tunnel. This study investigated skin integration on segments of Heartmate 3 driveline: smooth polyurethane, velour, and on a custom MEW scaffold in a small animal model. METHODS: Drivelines with surfaces consisting of smooth polyurethane, velour bonded to smooth polyurethane, and smooth polyurethane with a MEW scaffold sleeve were implanted percutaneously in the dorsum of 42 rats. Each rat was implanted with 2 pieces of driveline of 2 cm in length. Skin integration was assessed after 7 and 14 days. RESULTS: Macroscopically, velour and MEW scaffold surfaces were anchored at the driveline-skin interface while smooth polyurethane samples were not attached. The histology analyses showed epidermal migration throughout the thickness of the velour and MEW scaffold groups. Evident tissue growth around single MEW scaffold fibers resulted in full coverage of the pores, while areas of compacted fibers were apparent in the velour group. Tissue ingrowth was significantly higher in the MEW group compared to the velour group after 7 (p < 0.0001) and 14 days (p < 0.0001). Marsupialization was observed in the smooth polyurethane samples. Mechanical pull-out forces were similar between velour and MEW scaffold groups at 7 and 14 days (p > 0.05). CONCLUSIONS: Velour and MEW scaffolds promoted epidermal integration while smooth polyurethane drivelines did not. Fine control of MEW scaffold structure production resulted in full cellular coverage and may reduce driveline infection.

Infection after primary total knee arthroplasty: a randomized controlled prospective study of the addition of antibiotics to bone cement.

Objective The present prospective, randomized and controlled study was conducted with 286 patients submitted to primary total knee arthroplasty (TKA) with the objective of evaluating the efficacy of the addition of antibiotics to bone cement as a way to prevent post arthroplasty infection (PAI). Methods The patients were randomized into two groups: bone cement without antibiotic (No ATB, n = 158) or cement with antibiotic (ATB, n = 128), in which 2 g of vancomycin was added to 40 g of cement. The patients were followed up for 24 months after surgery. Results Regarding preoperative demographic data, the distribution of patients between groups was homogeneous ( p < 0.05). In the 24-month period, the overall infection rate was of 2.09% (6/286), with no difference (odds ratio [OR] = 1.636; 95% confidence interval [CI]: 0.294-9.080; p = 0.694) between the ATB group (1.56%; 2/128) and the No ATB group (2.53%; 4/158). In the No ATB group, the infection was caused by methicillin-resistant Staphylococcus aureus (MRSA) ( n = 2), methicillin-sensitive S. aureus (MSSA) ( n = 1) and Eschirichia coli ( n = 1). Proteus mirabilis and MSSA were isolated from patients in the ATB group. Among the comorbidities, all patients with PAI were hypertensive and nondiabetic. Two rheumatoid arthritis patients who developed PAI were from the ATB group. Conclusion The use of cement with ATB reduced the absolute number of infections, but without statistical difference between the groups; thus, routine use should not be encouraged.

PTH1-34 improves devitalized allogenic bone graft healing in a murine femoral critical size defect.

The treatment of large segmental defects of long bones resulting from trauma, infection, or bone tumor resections is a major challenge for orthopedic surgeons. The reconstruction of bone defects with acellular allografts can be used as an osteoconductive approach. However, devitalized allografts are associated with high rates of clinical failure as a result of poor intrinsic osteoinduction properties and a lack of further remodeling. Nevertheless, evidence suggests that due to its anabolic properties, teriparatide (PTH1-34) could be effective as an adjuvant therapy for massive allograft healing. Therefore, our goal was to investigate in a murine critical-sized defect model whether the intermittent administration of PTH1-34 improves the incorporation and revitalization of acellular structural bone allografts. Thus, a 2.5-mm critical-sized defect was established in the right femur of C57BL/6 mice, followed by the reconstruction with a devitalized cortical structural allograft. A titanium micro locking plate was applied to the anterior femoral surface and secured in place with self-tapping locking screws. Subsequently, daily doses of PTH1-34 (30, and 40 µg/kg) or saline were administered to the mice for 14 days after surgery. The mice were maintained without PTH1-34 therapy for an additional 7 days before being euthanized at 3 weeks post-surgery. Bone graft consolidation was assessed on radiographic images and by histomorphometric analysis. Additionally, to determine the frequency of osteoprogenitor cells in the bone marrow and their in vitro osteogenic capacity, stromal cells were isolated from the bone marrow of animals treated with 30 or 40 µg/kg/day of PTH1-34 following the same protocol used for the experimental animals. Our results suggest that intermittent PTH1-34 treatment at 30 µg/kg/day after femoral allograft reconstruction surgery accelerated the healing process as evidenced by new bone formation induced on endosteal and periosteal surfaces, enhanced revitalization of allogeneic graft, and increased frequency and osteogenic capacity of bone marrow stromal cells (BMSC). These findings should encourage further studies aimed at investigating the potential therapeutic use of intermittent PTH1-34, specifically with regards to the optimal dosing regimen in clinically challenging orthopedic scenarios.

Tranexamic acid use in high-risk blood transfusion patients undergoing total hip replacement: a randomised controlled trial.

INTRODUCTION: We hypothesised that a single preoperative intravenous dose of tranexamic acid (TXA) is effective in patients who undergo total hip arthroplasty (THA) and are at high risk of blood transfusion (preoperative haemoglobin level <13.0 g/dL). METHODS: A prospective, randomised controlled study of 308 patients who underwent primary THA was conducted. 256 participants remained in the study and were divided into 2 major groups: high-risk group comprising 116 patients with preoperative Hb < 13.0 g/dL (57 of whom were treated with a 15 mg/kg intravenous bolus of TXA, and 59 of whom did not receive the medication) and low-risk group comprising 140 patients with Hb ⩾ 13.0 g/dL (71 of whom received the same dose of TXA, and 69 of whom did not). Participants were followed up at 3 weeks, 3 months, 6 months, and 1 year after surgery. RESULTS: The use of TXA in both groups of patients significantly increased the levels of postoperative Hb and Ht. TXA protected high-risk patients from blood loss and from transfusion. In low-risk patients the use of TXA reduced blood loss but did not protect from blood transfusion. The median length of stay was significantly affected for high-risk patients. No thromboembolic event was recorded in either group. CONCLUSIONS: TXA reduces intra- and postoperative bleeding, transfusion rates, and the length of hospital stays in patients with low preoperative Hb. The use of TXA in patients with normal preoperative Hb reduces blood loss but does not affect the transfusion rate.ClinicalTrials.gov Identifier: NCT03019198.

Convergence of 3D printed biomimetic wound dressings and adult stem cell therapy.

Biomimetically designed medical-grade polycaprolactone (mPCL) dressings are 3D-printed with pore architecture and anisotropic mechanical characteristics that favor skin wound healing with reduced scarring. Melt electrowritten mPCL dressings are seeded with human gingival tissue multipotent mesenchymal stem/stromal cells and cryopreserved using a clinically approved method. The regenerative potential of fresh or frozen cell-seeded mPCL dressing is compared in a splinted full-thickness excisional wound in a rat model over six weeks. The application of 3D-printed mPCL dressings decreased wound contracture and significantly improved skin regeneration through granulation and re-epithelialization compared to control groups. Combining 3D-printed biomimetic wound dressings and precursor cell delivery enhances physiological wound closure with reduced scar tissue formation.

Occurrence of multiple genotype infection caused by Leishmania infantum in naturally infected dogs.

Genetic polymorphisms in natural Leishmania populations have been reported in endemic areas. Microsatellite typing is a useful tool to elucidate the genetic variability of parasite strains, due to its capability for high-resolution mapping of genomic targets. The present study employed multilocus microsatellite typing (MLMT) to explore the genotypic composition of Leishmania infantum in naturally infected dogs by genotyping parasites infecting different tissues with or without in vitro expansion. Eighty-six samples were collected from 46 animals in an endemic region of visceral leishmaniasis (VL). MLMT was performed for 38 spleen samples and 48 L. infantum cultures isolated from different tissues. Of the 86 samples, 23 were effectively genotyped by MLMT, identifying nine multilocus genotypes (MLG; referred to as MLG A-I). MLGs A, B and C were detected in more than one type of tissue and in more than one sample. Conversely, MLG D-I were uniquely detected in one sample each. The results showed that multiple genotype infections occur within a single host and tissue. Paired sample analysis revealed the presence of different MLMT alleles in 14 dogs, while the same MLG allele was present in 15 animals. STRUCTURE analysis demonstrated the presence of two populations; 13 samples displayed a similar admixture of both ancestral populations, and these were not assigned to any population. Only samples for which Q ≥ 0.70 after CLUMPP alignment were considered to be part of Population 1 (POP1) or Population 2 (POP2). POP2 comprised the majority of samples (n = 54) compared to POP1 (n = 19). This study presents evidence of multiple genotype infections (caused by L. infantum) in dogs in an area with high VL transmission. Further investigations must be undertaken to determine the effects of multiple infection on the host immune response and disease dynamics and treatment.

Parasite load induces progressive spleen architecture breakage and impairs cytokine mRNA expression in Leishmania infantum-naturally infected dogs.

Canine Visceral Leishmaniasis (CVL) shares many aspects with the human disease and dogs are considered the main urban reservoir of L. infantum in zoonotic VL. Infected dogs develop progressive disease with a large clinical spectrum. A complex balance between the parasite and the genetic/immunological background of the host are decisive for infection evolution and clinical outcome. This study comprised 92 Leishmania infected mongrel dogs of various ages from Mato Grosso, Brazil. Spleen samples were collected for determining parasite load, humoral response, cytokine mRNA expression and histopathology alterations. By real-time PCR for the ssrRNA Leishmania gene, two groups were defined; a low (lowP, n = 46) and a high parasite load groups (highP, n = 42). When comparing these groups, results show variable individual humoral immune response with higher specific IgG production in infected animals but with a notable difference in CVL rapid test optical densities (DPP) between highP and lowP groups. Splenic architecture disruption was characterized by disorganization of white pulp, more evident in animals with high parasitism. All cytokine transcripts in spleen were less expressed in highP than lowP groups with a large heterogeneous variation in response. Individual correlation analysis between cytokine expression and parasite load revealed a negative correlation for both pro-inflammatory cytokines: IFNγ, IL-12, IL-6; and anti-inflammatory cytokines: IL-10 and TGFß. TNF showed the best negative correlation (r2 = 0.231; p<0.001). Herein we describe impairment on mRNA cytokine expression in leishmania infected dogs with high parasite load associated with a structural modification in the splenic lymphoid micro-architecture. We also discuss the possible mechanism responsible for the uncontrolled parasite growth and clinical outcome.