Browsing by Subject "Prostheses and Implants"

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    ItemOpen Access
    Controlled Release of Vancomycin and Tigecycline from an Orthopaedic Implant Coating Prevents Staphylococcus aureus Infection in an Open Fracture Animal Model.
    (BioMed research international, 2019-01) Stavrakis, AI; Zhu, S; Loftin, AH; Weixian, X; Niska, J; Hegde, V; Segura, T; Bernthal, NM
    Introduction:Treatment of open fractures routinely involves multiple surgeries and delayed definitive fracture fixation because of concern for infection. If implants were made less susceptible to infection, a one-stage procedure with intramedullary nailing would be more feasible, which would reduce morbidity and improve outcomes. Methods:In this study, a novel open fracture mouse model was developed using Staphylococcus aureus (S. aureus) and single-stage intramedullary fixation. The model was used to evaluate whether implants coated with a novel "smart" polymer coating containing vancomycin or tigecycline would be colonized by bacteria in an open fracture model infected with S. aureus. In vivo bioluminescence, ex vivo CFUs, and X-ray images were evaluated over a 42-day postoperative period. Results:We found evidence of a markedly decreased bacterial burden with the local release of vancomycin and tigecycline from the PEG-PPS polymer compared to polymer alone. Vancomycin was released in a controlled fashion and maintained local drug concentrations above the minimum inhibition concentration for S. aureus for greater than 7 days postoperatively. Bacteria were reduced 139-fold from implants containing vancomycin and undetected from the bone and soft tissue. Tigecycline coatings led to a 5991-fold reduction in bacteria isolated from bone and soft tissue and 15-fold reduction on the implants compared to polymer alone. Antibiotic coatings also prevented osteomyelitis and implant loosening as observed on X-ray. Conclusion:Vancomycin and tigecycline can be encapsulated in a polymer coating and released over time to maintain therapeutic levels during the perioperative period. Our results suggest that antibiotic coatings can be used to prevent implant infection and osteomyelitis in the setting of open fracture. This novel open fracture mouse model can be used as a powerful in vivo preclinical tool to evaluate and optimize the treatment of open fractures before further studies in humans.
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    ItemOpen Access
    Decreased hernia recurrence using autologous platelet-rich plasma (PRP) with Strattice™ mesh in a rodent ventral hernia model.
    (Surgical endoscopy, 2016-08) Van Eps, Jeffrey; Fernandez-Moure, Joseph; Cabrera, Fernando; Wang, Xin; Karim, Azim; Corradetti, Bruna; Chan, Paige; Dunkin, Brian; Tasciotti, Ennio; Weiner, Bradley; Ellsworth, Warren

    Background

    Recurrence after ventral hernia repair (VHR) remains a multifactorial problem still plaguing surgeons today. Some of the many contributing factors include mechanical strain, poor tissue-mesh integration, and degradation of matrices. The high recurrence rate witnessed with the use of acellular dermal matrices (ADM) for definitive hernia repair has reduced their use largely to bridging repair and breast reconstruction. Modalities that improve classic cellular metrics of successful VHR could theoretically result in improved rates of hernia recurrence; autologous platelet-rich plasma (PRP) may represent one such tool, but has been underinvestigated for this purpose.

    Methods

    Lewis rats (32) had chronic ventral hernias created surgically and then repaired with Strattice™ mesh alone (control) or mesh + autologous PRP. Samples were harvested at 3 and 6 months postoperatively and compared for gross, histologic, and molecular outcomes of: neovascularization, tissue incorporation, peritoneal adhesions, hernia recurrence, and residual mesh thickness.

    Results

    Compared to control at 3 months postoperatively, PRP-treated rats displayed significantly more neovascularization of implanted mesh and considerable upregulation of both angiogenic genes (vEGF 2.73-fold, vWF 2.21-fold) and myofibroblastic genes (αSMA 9.68-fold, FSP-1 3.61-fold, Col1a1 3.32-fold, Col31a1 3.29-fold). Histologically, they also showed enhanced tissue deposition/ingrowth and diminished chronic immune cell infiltration. Peritoneal adhesions were less severe at both 3 (1.88 vs. 2.94) and 6 months (1.63 vs. 2.75) by Modified Hopkins Adhesion Scoring. PRP-treated rats experienced decreased hernia recurrence at 6 months (0/10 vs. 7/10) and had significantly improved ADM preservation as evidenced by quantification of residual mesh thickness.

    Conclusions

    PRP is an autologous source of pro-regenerative growth factors and chemokines uniquely suited to soft tissue wound healing. When applied to a model of chronic VHR, it incites enhanced angiogenesis, myofibroblast recruitment and tissue ingrowth, ADM preservation, less severe peritoneal adhesions, and diminished hernia recurrence. We advocate further investigation regarding PRP augmentation of human VHR.
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    ItemOpen Access
    Effective Prevention of Proximal Junctional Failure in Adult Spinal Deformity Surgery Requires a Combination of Surgical Implant Prophylaxis and Avoidance of Sagittal Alignment Overcorrection.
    (Spine, 2020-02) Line, Breton G; Bess, Shay; Lafage, Renaud; Lafage, Virgine; Schwab, Frank; Ames, Christopher; Kim, Han Jo; Kelly, Michael; Gupta, Munish; Burton, Douglas; Hart, Robert; Klineberg, Eric; Kebaish, Khaled; Hostin, Richard; Mundis, Gregory; Eastlack, Robert; Shaffrey, Christopher; Smith, Justin S; International Spine Study Group

    Study design

    Propensity score matched analysis of a multi-center prospective adult spinal deformity (ASD) database.

    Objective

    Evaluate if surgical implant prophylaxis combined with avoidance of sagittal overcorrection more effectively prevents proximal junctional failure (PJF) than use of surgical implants alone.

    Summary of background data

    PJF is a severe form of proximal junctional kyphosis (PJK). Efforts to prevent PJF have focused on use of surgical implants. Less information exists on avoidance of overcorrection of age-adjusted sagittal alignment to prevent PJF.

    Methods

    Surgically treated ASD patients (age ≥18 yrs; ≥5 levels fused, ≥1 year follow-up) enrolled into a prospective multi-center ASD database were propensity score matched (PSM) to control for risk factors for PJF. Patients evaluated for use of surgical implants to prevent PJF (IMPLANT) versus no implant prophylaxis (NONE), and categorized by the type of implant used (CEMENT, HOOK, TETHER). Postoperative sagittal alignment was evaluated for overcorrection of age-adjusted sagittal alignment (OVER) versus within sagittal parameters (ALIGN). Incidence of PJF was evaluated at minimum 1 year postop.

    Results

    Six hundred twenty five of 834 eligible for study inclusion were evaluated. Following PSM to control for confounding variables, analysis demonstrated the incidence of PJF was lower for IMPLANT (n = 235; 10.6%) versus NONE (n = 390: 20.3%; P < 0.05). Use of transverse process hooks at the upper instrumented vertebra (HOOK; n = 115) had the lowest rate of PJF (7.0%) versus NONE (20.3%; P < 0.05). ALIGN (n = 246) had lower incidence of PJF than OVER (n = 379; 12.0% vs. 19.2%, respectively; P < 0.05). The combination of ALIGN-IMPLANT further reduced PJF rates (n = 81; 9.9%), while OVER-NONE had the highest rate of PJF (n = 225; 24.2%; P < 0.05).

    Conclusion

    Propensity score matched analysis of 625 ASD patients demonstrated use of surgical implants alone to prevent PJF was less effective than combining implants with avoidance of sagittal overcorrection. Patients that received no PJF implant prophylaxis and had sagittal overcorrection had the highest incidence of PJF.

    Level of evidence

    3.
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    ItemOpen Access
    Implant healing in experimental animal models of diabetes.
    (J Diabetes Sci Technol, 2011-05-01) Le, NN; Rose, MB; Levinson, H; Klitzman, B
    Diabetes mellitus is becoming increasingly prevalent worldwide. Additionally, there is an increasing number of patients receiving implantable devices such as glucose sensors and orthopedic implants. Thus, it is likely that the number of diabetic patients receiving these devices will also increase. Even though implantable medical devices are considered biocompatible by the Food and Drug Administration, the adverse tissue healing that occurs adjacent to these foreign objects is a leading cause of their failure. This foreign body response leads to fibrosis, encapsulation of the device, and a reduction or cessation of device performance. A second adverse event is microbial infection of implanted devices, which can lead to persistent local and systemic infections and also exacerbates the fibrotic response. Nearly half of all nosocomial infections are associated with the presence of an indwelling medical device. Events associated with both the foreign body response and implant infection can necessitate device removal and may lead to amputation, which is associated with significant morbidity and cost. Diabetes mellitus is generally indicated as a risk factor for the infection of a variety of implants such as prosthetic joints, pacemakers, implantable cardioverter defibrillators, penile implants, and urinary catheters. Implant infection rates in diabetic patients vary depending upon the implant and the microorganism, however, for example, diabetes was found to be a significant variable associated with a nearly 7.2% infection rate for implantable cardioverter defibrillators by the microorganism Candida albicans. While research has elucidated many of the altered mechanisms of diabetic cutaneous wound healing, the internal healing adjacent to indwelling medical devices in a diabetic model has rarely been studied. Understanding this healing process is crucial to facilitating improved device design. The purpose of this article is to summarize the physiologic factors that influence wound healing and infection in diabetic patients, to review research concerning diabetes and biomedical implants and device infection, and to critically analyze which diabetic animal model might be advantageous for assessing internal healing adjacent to implanted devices.
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    Predictors of Revision Surgical Procedure Excluding Wound Complications in Adult Spinal Deformity and Impact on Patient-Reported Outcomes and Satisfaction: A Two-Year Follow-up.
    (The Journal of bone and joint surgery. American volume, 2016-04) Passias, Peter G; Soroceanu, Alexandra; Yang, Sun; Schwab, Frank; Ames, Christopher; Boniello, Anthony; Smith, Justin; Shaffrey, Christopher; Boachie-Adjei, Oheneba; Mundis, Gregory; Burton, Douglas; Klineberg, Eric; Hart, Robert; Hamilton, D Kojo; Sciubba, Daniel M; Bess, Shay; Lafage, Virginie

    Background

    The surgical procedure to treat adult spinal deformity is challenging, with high rates of complications, including revision procedures performed to repair instrumentation failure or unplanned surgical complications. This study quantifies the incidence of, identifies predictors for, and determines health-related quality-of-life changes associated with revision procedures to treat adult spinal deformity.

    Methods

    We analyzed a multicenter database of patients who underwent a surgical procedure for adult spinal deformity, which was defined as having an age of eighteen years or older and scoliosis of ≥20°, sagittal vertical axis of ≥5 cm, pelvic tilt of ≥25°, and/or thoracic kyphosis of >60°. We focused on demographic, radiographic, health-related quality-of-life, and operative data at the two-year follow-up. Patients with primary infections were excluded. Predictive and confounding variables for revisions were identified using univariate analysis and multivariate logistic regression modeling.

    Results

    Two hundred and forty-three patients were included in this study; of these patients, forty (16.5%) underwent a revision surgical procedure (15% of these at six weeks, 38% between six weeks and one year, and 48% between one and two years). Screw or cage-related implant complications were the most common indications for revision, followed by proximal junctional kyphosis and rod failure. Positive predictors for a revision surgical procedure included total body mass, with an odds ratio of 1.33 (95% confidence interval, 1.04 to 1.70) per 10-kg increase, and preoperative sagittal vertical axis, with an odds ratio of 1.15 (95% confidence interval, 1.04 to 1.28) per 2-cm increase. Factors associated with lower risk of revision included use of bone morphogenetic protein-2 (BMP-2) (odds ratio, 0.16 [95% confidence interval, 0.05 to 0.47]) and greater diameter rods (odds ratio, 0.51 [95% confidence interval, 0.29 to 0.89]). Body mass index, although initially considered a potential predictor for a revision surgical procedure, was not significantly different between primary and revision cohorts on univariate analysis and was therefore not input into the multivariate model. All patients improved in two-year health-related quality-of-life scores; revision subjects had lower overall improvement (Scoliosis Research Society [SRS] score; p = 0.016) from baseline. Revision status did not predict two-year patient satisfaction (p = 0.726), as measured by the SRS Satisfaction domain (SRS-22r).

    Conclusions

    Patients with greater preoperative sagittal vertical axis and high total body mass are at a higher risk for a revision surgical procedure following procedures to treat adult spinal deformity. Larger diameter rods and BMP-2 were associated with decreased revision odds. Revisions did not impact patient satisfaction at two years.

    Level of evidence

    Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.