Clinical outcomes and safety of the SpineJack vertebral augmentation system for the treatment of vertebral compression fractures in a United States patient population.

The SpineJack implant system was recently FDA approved for treatment of vertebral compression fractures (VCF), however United States-based outcomes data is lacking. We sought to examine the safety and clinical outcomes following vertebral augmentation using the SpineJack implant for treatment of VCF in a U.S. patient population. An IRB-approved, retrospective study of SpineJack implants used in vertebral augmentation was performed from 11/2018 to 2/2020. Outcome objectives included pain improvement, vertebral body height (VH) restoration, improvement in local kyphotic angle (LKA), and incidence of adjacent level fractures (ALF). Complications were reviewed to assess safety of the procedure. Thirty patients with VCF (60% female; mean [SD] age of 62.7 [±12.8] years) underwent a total of 53 vertebral augmentations with 106 SpineJack implants. Worst pain scores decreased significantly from 8.7 to 4.3 (95%CI of the change [Δ]: 4.3-4.4; p < 0.001). Middle and anterior VH significantly increased from 13.1 ± 0.2 to 15.9 ± 0.2 mm (95%CI Δ: 2.6-2.9 mm; p < 0.001) and 15.6 ± 0.2 to 16.8 ± 0.2 mm (95%CI Δ: 1.1-1.4 mm; p < 0.001), respectively. LKA was significantly decreased from 10.0 ± 2.1 to 7.4 ± 2.1 degrees (95%CI Δ: 2.4-2.8 degrees; p < 0.001). Four patients (13%) sustained ten ALF over a median (IQR) follow up period of 94 (17.5-203) days. There were no major adverse events during the follow up period. To summarize, vertebral augmentation with SpineJack implants of patients with VCF resulted in significantly decreased pain, restored VH, and improved LKA, without major adverse events. However, 13% of patients sustained ALF during a median follow up period of 3 months.

Building Organs Using Tissue-Specific Microenvironments: Perspectives from a Bioprosthetic Ovary.

Recent research in tissue engineering and regenerative medicine has elucidated the importance of the matrisome. The matrisome, effectively the skeleton of an organ, provides physical and biochemical cues that drive important processes such as differentiation, proliferation, migration, and cellular morphology. Leveraging the matrisome to control these and other tissue-specific processes will be key to developing transplantable bioprosthetics. In the ovary, the physical and biological properties of the matrisome have been implicated in controlling the important processes of follicle quiescence and folliculogenesis. This expanding body of knowledge is being applied in conjunction with new manufacturing processes to enable increasingly complex matrisome engineering, moving closer to emulating tissue structure, composition, and subsequent functions which can be applied to a variety of tissue engineering applications.

Long-term complications and implant survival rates after cranioplastic surgery: a single-center study of 392 patients.

Cranioplasty (CP) is a standard procedure in neurosurgical practice for patients after (decompressive) craniectomy. However, CP surgery is not standardized, is carried out in different ways, and is associated with considerable complication rates. Here, we report our experiences with the use of different CP materials and analyze long-term complications and implant survival rates. We retrospectively studied patients who underwent CP surgery at our institution between 2004 and 2014. Binary logistic regression analysis was performed in order to identify risk factors for the development of complications. Kaplan-Meier analysis was used to estimate implant survival rates. A total of 392 patients (182 females, 210 males) with a mean age of 48 years were included. These patients underwent a total of 508 CP surgeries. The overall complication rate of primary CP was 33.2%, due to bone resorption/loosening (14.6%) and graft infection (7.9%) with a mean implant survival of 120 ± 5 months. Binary logistic regression analysis showed that young age (< 30 years) (p = 0.026, OR 3.150), the presence of multidrug-resistant bacteria (p = 0.045, OR 2.273), and cerebrospinal fluid (CSF) shunt (p = 0.001, OR 3.137) were risk factors for postoperative complications. The use of titanium miniplates for CP fixation was associated with reduced complication rates and bone flap osteolysis as well as longer implant survival rates. The present study highlights the risk profile of CP surgery. Young age (< 30 years) and shunt-dependent hydrocephalus are associated with postoperative complications especially due to bone flap autolysis. Furthermore, a rigid CP fixation seems to play a crucial role in reducing complication rates.

Incidence and Risk Factors for Unplanned Return to the Operating Room Following Primary Definitive Fusion for Pediatric Spinal Deformity: A Multicenter Study with Minimum 2-year Follow-Up.

STUDY DESIGN: A retrospective multicenter cohort study. OBJECTIVE: The aim of this study was to identify the incidence and risk factors for UPROR within minimum 2-year follow-up in primary definitive fusion for pediatric spinal deformity. SUMMARY OF BACKGROUND DATA: Several previous reports have elucidated the incidence of complications after pediatric scoliosis surgery; however, there has been no study that described the incidence and risk factors for unplanned return to the operating room (UPROR) with long-term follow-up in surgery for pediatric scoliosis with every etiology. METHODS: We retrospectively extracted data of patients aged <19 years, from 14 institutes in Japan, who underwent primary definitive fusion surgery for spinal deformity between January 1, 2015 and December 31, 2017. The primary outcomes were the incidence of UPROR within the minimum 2-year follow-up period for any reason. Univariate and multivariate logistical analyses were conducted to identify potential risk factors associated with UPROR. RESULTS: We identified 1417 eligible patients (287 males and 1130 females) with a mean age of 13.9 years. UPROR for any reason within minimum 2-year follow-up was identified in 68 patients (4.8%). The most frequent cause for UPROR was implant failure found in 29 patients, followed by surgical site infection in 14 patients, junctional problems in 10 patients, and neurological complications in six patients. The multivariate logistic regression analysis revealed that a diagnosis of kyphosis (odds ratio [OR], 2.65; 95% confidence interval [CI] 1.16-6.04), etiology of congenital or structural type (OR 2.21; 95% CI 1.08-4.53), etiology of syndromic type (OR 2.67; 95% CI 1.27-5.64), and increased operation time of ≥300 minutes (OR 1.81; 95% CI 1.07-3.07) were the risk factors for the incidence of UPROR. CONCLUSION: The present multicenter study identified for the first time the incidence and risk factors for UPROR with minimum 2-year follow-up after primary definitive fusion surgery for pediatric spinal deformity with every etiology.Level of Evidence: 3.

Surgical and functional outcomes of two types of transcutaneous bone conduction implants.

OBJECTIVE: This study aimed to evaluate surgical and functional outcomes, in a tertiary referral centre, of two different types of semi-implantable transcutaneous bone conduction devices. METHOD: This study involved prospective data collection and review of patients implanted between November 2014 and December 2016. Glasgow Hearing Aid Inventory (Glasgow Hearing Aid Benefit Profile or Glasgow Hearing Aid Difference Profile) and Client Oriented Scale of Improvement were completed where appropriate. Surgical and audiological outcomes were recorded in the surgical notes. RESULTS: Glasgow Hearing Aid Difference Profile and Glasgow Hearing Aid Benefit Profile showed similar mean score in the active and the passive transcutaneous bone conduction devices. Client Oriented Scale of Improvement showed improvements in listening situations. Post-operative speech reception threshold showed better mean threshold in the active transcutaneous bone conduction devices group when compared with the passive transcutaneous bone conduction devices group. No device failures or surgical complications existed in either group, with the surgical time being less in the passive transcutaneous bone conduction devices group. CONCLUSION: Both devices are reliable semi-implantable transcutaneous bone conduction devices with excellent surgical and functional outcomes and patient satisfaction. Overall surgical time was much less in the passive transcutaneous bone conduction devices group with no necessity for pre-planning. This is much easier to remove with the possibility of conversion to other devices in the manufacturer's portfolio and wide-ranging wireless accessories. Further studies are needed to assess the longer-term results in a bigger population.

Comparison of 4 sinus augmentation techniques for implant placement with residual alveolar bone height ≤3 mm.

This study compared implant outcomes following maxillary sinus floor augmentation (MSFA) in edentulous patients with a residual alveolar bone height ≤3 mm. Four techniques were evaluated: 1-stage bone-added osteotome sinus floor elevation procedure (BAOSFE) with simultaneous implant placement; 2-stage BAOSFE with delayed implant placement; 1-stage lateral window sinus floor elevation with simultaneous implant placement; and 2-stage lateral window sinus floor elevation with delayed implant placement. Patients were followed for 18 to 72 months (mean: 52.5 months) after prosthesis placement. Data were analyzed with cone-beam computed tomography. A total of 96 implants from 71 patients were analyzed; pretreatment, there were no significant differences between patients. Total implant survival was 98.9%. The mean residual bone height was significantly higher in the 1-stage BAOSFE group than the other groups (P < .01); 1 implant in this group failed at 3 months. There was no significant difference in total bone height gain between groups. However, the bone height gain of 1st sinus lifting with 2-stage BAOSFE was significantly lower than the 2-stage lateral window procedure (P < .01). There was no prosthesis failure. The favorable implant outcomes suggest these 1-stage and 2-stage MSFA procedures should be considered as alternative treatment options for patients with extremely atrophic posterior maxilla.

Education in prosthetic and orthotic training: Looking back 50 years and moving forward.

There is a long history of prosthetic and orthotic services helping to mitigate the impact of physical impairment by restoring function, and enabling and equipping the user. The training of health professionals who design, fit, and maintain prosthetic and orthotic devices has evolved over the centuries, reflecting an increase in knowledge, technology, understanding, and social attitudes in each era. Improvements in pedagogical thinking and biomechanical understanding, as well as the advent of new integrated technologies, have driven the profession over the past 50 years to modernize, evolve training and service delivery models in line with new attitudes toward clients, and search for new ways to improve users' quality of life. In this narrative review, the authors examined the evolution of prosthetic and orthotic education, the impact of changing educational techniques and technologies, and the impact of the International Society for Prosthetics and Orthotics in that process. Through conversations with experts and review of peer-reviewed literature, accreditation documents, and the International Society for Prosthetics and Orthotics records and databases, the authors identified three areas of change in prosthetics and orthotics education over the past 50 years: (1) prosthetic/orthotic curriculum content, (2) pedagogy and course delivery, and (3) internships/residencies. This narrative review is a snapshot of a growing profession and we can only speculate where the next 50 years will lead us as we strive to serve patients, ever placing their needs and aspirations at the center of this professional service.

Prosthetists and orthotists: An evolution from mechanic to clinician.

Fifty years ago, the International Society for Prosthetics and Orthotics was founded in recognition that this unique niche in rehabilitation would benefit from multidisciplinary interactions between specialists in engineering, therapy, and medicine.Since then, field evolved from having a craft orientation toward a technology and clinical specialty. This anniversary provides an opportunity to look back on advances in prosthetics and orthotics, and the clear impact they have had on changing the skills needed by the prosthetist/orthotist as new technology and techniques have emerged. The balance has clearly shifted from mechanical skills to clinical care. The training and skills of the prosthetist/orthotist remain unique and valued in the rehabilitation team, and the primary motivation remains the same as it has been since the creation of the International Society for Prosthetics and Orthotics: the application of external devices where they are suitable to address the many varied needs of persons with disability. This historical perspective puts into context why and how the profession has changed, while also reinforcing that it is the goals set for restoring patient functions that best defines what it is to be a prosthetist/orthotist, not the means we use.

A toolkit for prosthetists and orthotists to facilitate progress in professional communication over the next 50 years.

BACKGROUND: In this celebratory issue of Prosthetics and Orthotics International, we review professional communication skills in the field of prosthetics and orthotics. OBJECTIVE: We aim to reflect on communication skills in the past 50 years, to discuss developments in the coming 50 years, and to create a toolkit and research agenda to facilitate progress in professional communication in the next 50 years. RESULTS: Despite being a key area in prosthetics and orthotics training programmes, we found no studies on professional communication with an experimental design published in Prosthetics and Orthotics International. As an alternative, we provide clinical reflections on the changes in professional communication in the past 50 years, and we discuss questionnaire-based and qualitative studies that provide evidence for the importance of communication in pedorthic footwear provision. In the coming 50 years, professional communication in the field of prosthetics and orthotics may be impacted by aging populations, global mobility, information technology, technological advances and emphasis on prevention. We discuss each of these topics. To facilitate progress in professional communication, we have created a toolkit with resources for prosthetics and orthotics professionals, prosthetics and orthotics students and other interested professionals. CONCLUSIONS: We hope this toolkit will inspire others to use, extend and implement it in their daily practice. As a research agenda, we strongly recommend undertaking research on interventions to improve professional communication and to study its effect on clinically meaningful outcomes.

Do Children With Spinal Deformity Who Have Metal Implants and Frequent Exposure to X-Rays Increase Their Risk of Cancer?

STUDY DESIGN: Spinal surgery cohort. OBJECTIVE: The authors assess the risk of cancer in children who have undergone frequent radiographs and have metal implants for the treatment of spinal deformity. SUMMARY OF BACKGROUND DATA: Concerns have been raised regarding the cancer risk to children exposed to repeated radiological examinations as part of routine surveillance to monitor progression of spinal deformity. Additionally, there are reports of increased cancer risk in adults having joint replacement with metal implants causing raised metal ion levels in the blood. METHODS: A large number of consecutive children undergoing instrumented spinal surgery since 1979 were examined for their development of malignancy. High quality data on all invasive cancers from the South Australian Cancer Registry and deaths were linked to the spinal surgery cohort with the calculation of standardized incidence ratios (SIRs) using the Quinquinquennium method. RESULTS: The study cohort was formed by 865 children. The average follow-up time from date of surgery to either death or censoring date was 18 years with a maximum of 36 years. A total of 15,921 person years were examined. There was no increased rate of cancer in these patients. For the total cohort, the SIR was 1.00 (95% confidence interval [CI] 0.50-1.79). For females the SIR was 0.83 (95% CI 0.33-1.70) and for males the SIR was 1.33 (95% CI 0.36-3.40). The male SIR reflected an expected cancer incidence of three cases, when four cases were observed, and was not statistically significant. CONCLUSION: This study has found that radiation exposure and possible exposure to circulating metal ions as a result of routine instrumented spine surgery in children since 1979 is not associated with an increased risk of cancer in up to 36 years of follow up. LEVEL OF EVIDENCE: 2.

Secondary "Hybrid Reconstruction" Concept with Silicone Implants After Autologous Breast Reconstruction - Is It Safe and Reasonable?

BACKGROUND The use of autologous tissue for breast reconstructive surgery following mastectomy has become routine and allows for excellent symmetry and aesthetic results. However, in some cases, the amount of tissue available from the utilized flaps is not enough to achieve the desired outcome. The use of autologous fat grafting, as well as other techniques, has been described to deal with such problems. However, though well-established, these techniques may also fail to achieve the desired results. The aim of this study was to highlight the opportunity to improve aesthetic results using a secondary prosthesis underneath the previously used free flap and to examine whether this is a safe and reasonable procedure. MATERIAL AND METHODS In our study we included patients with unsatisfied aesthetic results after free flap procedures (DIEP, S-GAP, TMG, and FCI) between 2011 and 2018. In each case described, a secondary prosthesis was placed underneath the original flap in order to improve symmetry, shape and projection. Patient age, indication for surgery, adjuvant therapy, complications and outcomes have been registered. A 12-point scale was established to analyze patient satisfaction and aesthetic outcome. RESULTS Overall "operative success" was achieved in all 13 patients (14 flaps) evaluated. At 12 months after reconstruction, all aesthetic scores collected were between good and excellent. In contrast to other studies, we chose a secondary approach for the flap augmentation and we used the epipectoral pocket for the placement of the implant. In our series, low rates of early and late post-operative complications were observed, with a high overall rate of satisfaction. CONCLUSIONS The demonstrated "Hybrid Breast Reconstruction" approach, using an implant underneath a free flap autologous breast reconstruction, provided a safe and reliable option to optimize breast reconstruction outcomes.

Design and Physical Properties of 3-Dimensional Printed Models Used for Neurointervention: A Systematic Review of the Literature.

BACKGROUND: Three-dimensional (3D) printing has revolutionized training, education, and device testing. Understanding the design and physical properties of 3D-printed models is important. OBJECTIVE: To systematically review the design, physical properties, accuracy, and experimental outcomes of 3D-printed vascular models used in neurointervention. METHODS: We conducted a systematic review of the literature between January 1, 2000 and September 30, 2018. Public/Publisher MEDLINE (PubMed), Web of Science, Compendex, Cochrane, and Inspec databases were searched using Medical Subject Heading terms for design and physical attributes of 3D-printed models for neurointervention. Information on design and physical properties like compliance, lubricity, flow system, accuracy, and outcome measures were collected. RESULTS: A total of 23 articles were included. Nine studies described 3D-printed models for stroke intervention. Tango Plus (Stratasys) was the most common material used to develop these models. Four studies described a population-representative geometry model. All other studies reported patient-specific vascular geometry. Eight studies reported complete reconstruction of the circle of Willis, anterior, and posterior circulation. Four studies reported a model with extracranial vasculature. One prototype study reported compliance and lubricity. Reported circulation systems included manual flushing, programmable pistons, peristaltic, and pulsatile pumps. Outcomes included thrombolysis in cerebral infarction, post-thrombectomy flow restoration, surgical performance, and qualitative feedback. CONCLUSION: Variations exist in the material, design, and extent of reconstruction of vasculature of 3D-printed models. There is a need for objective characterization of 3D-printed vascular models. We propose the development of population representative 3D-printed models for skill improvement or device testing.

Lumboperitoneal and Ventriculoperitoneal Shunting for Idiopathic Intracranial Hypertension Demonstrate Comparable Failure and Complication Rates.

BACKGROUND: Idiopathic intracranial hypertension results in increased intracranial pressure leading to headache and visual loss. This disease frequently requires surgical intervention through lumboperitoneal (LP) or ventriculoperitoneal (VP) shunting. OBJECTIVE: To compare postoperative outcomes between LP and VP shunts, including failure and complication rates. METHODS: A retrospective analysis was conducted using a national administrative database (MarketScan) to identify idiopathic intracranial hypertension (IIH) patients who underwent LP or VP shunting from 2007 to 2014. Multivariate logistic and Cox regressions were performed to compare rates of shunt failure and time to shunt failure between LP and VP shunts while controlling for demographics and comorbidities. RESULTS: The analytic cohort included 1082 IIH patients, 347 of whom underwent LP shunt placement at index hospitalization and 735 of whom underwent VP shunt placement. Rates of shunt failure were similar among patients with LP and VP shunt (34.6% vs 31.7%; P = .382). Among patients who experienced shunt failure, the mean number of shunt failures was 2.1 ± 1.6 and was similar between LP and VP cohorts. Ninety-day readmission rates, complication rates, and costs did not differ significantly between LP and VP shunts. Patients who experienced more than two shunt failures tended to have an earlier time to first shunt failure (hazard ratio 1.41; 95% confidence interval 1.08-1.85; P = .013). CONCLUSION: These findings suggest that LP and VP shunts may have comparable rates of shunt failure and complication. Regardless of shunt type, earlier time to first shunt failure may be associated with multiple shunt failures.

Future considerations in prosthetic urology.

Since their popularization, genitourinary prosthetics have remained a gold-standard therapy for the treatment of erectile dysfunction and stress urinary incontinence and in cases of testicular loss or dysfunction. They have also represented an area of significant innovation, which has contributed to excellent long-term outcomes. Given this history, the objective of the current review was to provide a 5-10-year outlook on anticipated trends and developments in the field of genitourinary prosthetics. To accomplish this objective, a PubMed and patent search was performed of topics relating to penile and testicular prostheses and urinary sphincters. In regard to penile prostheses, findings demonstrated several new concepts including temperature-sensitive alloys, automated pumps, devices designed specifically for neophalluses, and improved malleable designs. With artificial urinary sphincters, new concepts include the ability to add or remove fluid from an existing system, two-piece systems, and new mechanisms to occlude the urethra. For testicular prosthetics, future implementations may not only better replicate the feel of a biological testicle but also add endocrinological functions. Beyond device innovation, the future of prosthetics is also one of expanding geographic boundaries, which necessitates variable cost modeling and regulatory considerations. Surgical trends are also changing, with a greater emphasis on nonnarcotic, postoperative pain control, outpatient surgeries, and adjunctive techniques to lengthen the penis and address concomitant stress incontinence, among others. Concomitant with device and surgical changes, future considerations also include a greater need for education and training, particularly given the rapid expansion of sexual medicine into developing nations.

A Comparison of Ventriculoperitoneal and Ventriculoatrial Shunts in a Population of 544 Consecutive Pediatric Patients.

BACKGROUND: Although ventriculoperitoneal shunts (VPS) remain the first-line option in most instances of pediatric hydrocephalus, the long-term efficacy of ventriculoatrial shunts (VAS) remains unknown. OBJECTIVE: To characterize the long-term outcomes and adverse occurrences associated with both VPS and VAS at our institution. METHODS: The authors retrospectively analyzed all cerebrospinal fluid (CSF) shunting procedures performed over a 13-yr period at a single institution. A total of 544 pediatric shunt patients were followed for at least 90 d (VPS: 5.9 yr; VAS: 5.3 yr). RESULTS: A total of 54% of VPS and 60% of VAS required at least 1 revision. VPS demonstrated superior survival overall; however, if electively scheduled VAS lengthening procedures are not considered true "failures," no statistical difference is noted in overall survival (P = .08). VPS demonstrated significantly greater survival in patients less than 7 yr of age (P = .001), but showed no difference in older children (P = .4). VAS had a significantly lower rate of infection (P < .05) and proximal failure (P < .001). CONCLUSION: VAS can be a useful alternative to VPS when the abdomen is unsuitable, particularly in older children. Although VPS demonstrates superior overall survival, it should be understood that elective VAS lengthening procedures are often necessary, especially in younger patients. If elective lengthening procedures are not considered true failures, then the devices show similar survival.

Lumbar Arthroplasty: Past, Present, and Future.

Lumbar degenerative disc disease is a pathologic process that affects a large portion of our aging population. In the recent past, surgical treatment has involved fusion procedures. However, lumbar disc arthroplasty and replacement provides an alternative for carefully selected patients. It provides the major advantage of motion preservation and thus keeps adjacent segments from significantly progressive degeneration. The history of lumbar disc replacement has roots that start in the 1960s with the implantation of stainless-steel balls. Decades later, multiple implants with different material design and biomechanical properties were introduced to the market. New third-generation implants have made great strides in improved biomechanics and clinical outcomes. Although there is room for further advancement and studies are warranted to assess the long-term durability and sustainability of lumbar disc arthroplasty, it has certainly proven to be a very acceptable alternative within the surgical armamentarium that should be offered to patients who meet indications. In this review we present an overview of lumbar disc arthroplasty including its history, indications, biomechanics, challenges, and future directions.

Effects of Surface Topography and Chemistry on Polyether-Ether-Ketone (PEEK) and Titanium Osseointegration.

STUDY DESIGN: An in vivo study examining the functional osseointegration of smooth, rough, and porous surface topographies presenting polyether-ether-ketone (PEEK) or titanium surface chemistry. OBJECTIVE: To investigate the effects of surface topography and surface chemistry on implant osseointegration. SUMMARY OF BACKGROUND DATA: Interbody fusion devices have been used for decades to facilitate fusion across the disc space, yet debate continues over their optimal surface topography and chemistry. Though both factors influence osseointegration, the relative effects of each are not fully understood. METHODS: Smooth, rough, and porous implants presenting either a PEEK or titanium surface chemistry were implanted into the proximal tibial metaphyses of 36 skeletally mature male Sprague Dawley rats. At 8 weeks, animals were euthanized and bone-implant interfaces were subjected to micro-computed tomography analysis (n = 12), histology (n = 4), and biomechanical pullout testing (n = 8) to assess functional osseointegration and implant fixation. RESULTS: Micro-computed tomography analysis demonstrated that bone ingrowth was 38.9 ±â€Š2.8% for porous PEEK and 30.7 ±â€Š3.3% for porous titanium (P = 0.07). No differences in fixation strength were detected between porous PEEK and porous titanium despite titanium surfaces exhibiting an overall increase in bone-implant contact compared with PEEK (P < 0.01). Porous surfaces exhibited increased fixation strength compared with smooth and rough surfaces regardless of surface chemistry (P < 0.05). Across all groups both surface topography and chemistry had a significant overall effect on fixation strength (P < 0.05), but topography accounted for 65.3% of the total variance (ω = 0.65), whereas surface chemistry accounted for 5.9% (ω = 0.06). CONCLUSIONS: The effect of surface topography (specifically porosity) dominated the effect of surface chemistry in this study and could lead to further improvements in orthopedic device design. The poor osseointegration of existing smooth PEEK implants may be linked more to their smooth surface topography rather than their material composition. LEVEL OF EVIDENCE: N/A.