Low-Cost 3-D-Printer-Assisted Personalized Cranioplasty Treatment: A Case Series of 14 Consecutive Patients.

OBJECTIVE: The current study used polylactic acid molds [developed locally using three-dimensional printers and our software] and polymethyl methacrylate (PMMA) to perform cranioplasty of bone defects in technically demanding areas of the skull while ensuring ideal cosmetic results and functional recovery. The overall aim was to identify the ideal method for standard cranioplasty procedures METHODS: Polylactic acid duplicates of the skull defects were created for eligible patients, after which a two-part negative mold composed of plaster and silicone was used to form artificial bone with PMMA. Thereafter, cranioplasty was performed and the treatment success was assessed by evaluating the percentage of similarity objectively and the body image scale subjectively. RESULTS: No surgical complications were seen to occur in the 14 patients included in the current study. Furthermore, the subjective and objective evaluation revealed a significant improvement in outcomes (p < 0.05). No postoperative complications were observed over a follow-up period of 6 months, except in 1 patient who exhibited late infection. CONCLUSIONS: Cranioplasty operations were performed at an economical price of approximately US$50 dollars, suggesting that this method can be applied widely. Furthermore, preoperative preparation of the PMMA models can help reduce the duration of anesthesia and surgery which, in turn, will minimize the risk of surgical complications. Based on current knowledge in the field, we believe that this method represents the ideal technique.

Customized cost-effective polymethylmethacrylate cranioplasty: a cosmetic comparison with other low-cost methods of cranioplasty.

BACKGROUND: Intraoperative hand-moulded cranioplasty and polymethylmethacrylate (PMMA) prostheses made from bone impressions are economical but the cosmetic results are less than satisfactory. Commercially available customized prostheses perform better but are prohibitively expensive. We evaluate the performance of a locally developed, low-cost customized PMMA cranioplasty prosthesis. OBJECTIVE: To compare the cosmetic outcome of 3 types of PMMA cranioplasty as well as with objective measurements on postoperative CT scans METHODS: This study includes 70 patients who underwent cranioplasty between March 2016 and June 2020. In this period, patients had their cranioplasty prostheses made by intra-operative hand moulding (HM), by using the removed bone as a template and making a bone impression (BI) or by 3D printing the prosthesis based on a CT scan. Cosmetic outcomes were assessed by the patient and the operating surgeon on an 8-point scale. The degree of measured anthropometric asymmetry was measured on a postoperative CT scan and correlated with the cosmetic outcome. RESULTS: Our locally produced 3D-printed cranioplasty prostheses showed a statistically better performance in cosmetic scores when compared to the HM and BI (p value < 0.001). CT anthropometric measurements significantly correlated with cosmetic outcome (p value 0.01) CONCLUSION: Our 3D cranioplasty prostheses had better cosmetic outcomes than HM and BI prostheses, and our technique is able to produce them at 10% of the cost of the currently available commercial customized prostheses.

Percutaneous Vertebroplasty: A History of Procedure, Technology, Culture, Specialty, and Economics.

Percutaneous vertebroplasty (VP) progressed from a virtually unknown procedure to one performed on hundreds of thousands of patients annually. The development of VP provides a historically exciting case study into a rapidly adopted procedure. VP was the synthesis of information gained from spinal biopsy developments, the inception of biomaterials used in medicine, and the unique health care climate in France during the 1980s. It was designed as a revolutionary technique to treat vertebral body fractures with minimal side effects and was rapidly adopted and marketed in the United States. The impact of percutaneous vertebroplasty on spine surgery was profound.

Polymethylmethacrylate cranioplasty using low-cost customised 3D printed moulds for cranial defects - a single Centre experience: technical note.

We report our experience with 3D customised cranioplasties for large cranial defects. They were made by casting bone cement in custom made moulds at the time of surgery. Between October 2015 and January 2018, 29 patients underwent the procedure; 25 underwent elective cranioplasties for large cranial defects and four were bone tumour resection and reconstruction cases. The majority of patients (96.5%) reported a satisfactory aesthetic outcome. No infections related to the surgical procedure were observed in the follow-up period. The method proved to be effective and affordable.

Polymethyl Methacrylate in Patient-Specific Implants: Description of a New Three-Dimension Technique.

Polymethyl methacrylate (PMMA), an easily moldable and economical synthetic resin, has been used since the 1940s. In addition, PMMA has good mechanical properties and is one of the most biocompatible alloplastic materials currently available. The PMMA can serve as a spacer and as a delivery vehicle for antibiotics. Prior studies have indicated that no significant differences in infection rates exist between autologous and acrylic cranioplasty. Although inexpensive, the free-hand cranioplasty technique often yields unsatisfactory cosmetic results. In the present study, the application of a recently developed, economic modality for the perioperative application, and molding of PMMA to ensure a precise fit in 16 patients using computer-aided design, computer-aided manufacturing, and rapid prototyping was described.The mean defect size was 102.0 ±â€Š26.4 cm. The mean volume of PMMA required to perform the cranioplasty procedure was 51 mL. The cost of PMMA was approximately 6 Euro (&OV0556;) per mL. The costs of fabricating the implants varied from 119.8 &OV0556; to 1632.0 &OV0556; with a mean of 326.4 &OV0556; ±â€Š371.6. None of the implants required removal during the follow-up period.

Optimizing outcomes with polymethylmethacrylate fillers.

INTRODUCTION: The ideal filler should be long-lasting, biocompatible, chemically inert, soft and easy to use, and have a long history of safety. This review focuses on the evolution and development of the PMMA-collagen gel, Bellafill, and the 10 years of postmarketing experience of Bellafill since it received premarket approval (PMA) from the FDA as Artefill in 2006. Artefill was rebranded to Bellafill in 2015. METHODS: The authors conducted a literature search on PubMed for key articles describing the steps in which Arteplast, a PMMA filler developed in 1989, led to the development of Bellafill, the only PMMA filler approved by the US FDA for the treatment of nasolabial folds and acne scar correction. The factors governing efficacy and safety were also evaluated for the major PMMA fillers available in the world. RESULTS: The process of manufacturing and purifying PMMA has played a major role in minimizing adverse events for Bellafill. Postmarketing surveillance data for the 2007-2016 period show that for more than 530 000 Bellafill syringes distributed worldwide, 11 confirmed granulomas (excluding clinical trial data) (0.002% of syringes sold) have been reported. Data on other PMMA fillers are limited and inconsistent. The authors suggest that adverse events are often attributable to lack of proficiency in treatment technique and other factors. CONCLUSION: Bellafill has demonstrated an excellent safety and effectiveness profile in multiple clinical studies, customer feedback, and 10 years of postmarketing surveillance experience. Adverse events occur with all fillers for a variety of reasons. In addition to quality of the product, injector skill and technique are critical to ensuring good clinical outcomes.

Comparative Cost Analysis of Single and Mutli-Stage Temporal Deformity Correction Following Neurosurgical Procedures.

PURPOSE: Temporal hollowing deformity (THD) is a visible concavity/convexity in the temporal fossa; a complication often seen following neurosurgical/craniofacial procedures. Although numerous techniques have been described, no study to date has shown the healthcare costs associated with temporal hollowing correction surgery. Thus, the purpose here is to compare and contrast the direct costs related to temporal cranioplasty using various methods including: liquid poly-methyl-methacrylate (PMMA) implants with screw fixation, prebent, modified titanium mesh implants, and customized cranial implants (CCIs) with dual-purpose design. Understanding the financial implications related to this frequently encountered complication will help to motivate surgeons/healthcare facilities to better prevent and manage THD. METHODS: This is a single-surgeon, single-institution retrospective review of 23 THD patients randomly selected from between 2008 and 2015. Cost analysis variables include length of hospital stay, facility/professional fees, implant material fees, payer information, reimbursement rate, and net revenue. RESULTS: Of the 23 patients, ages ranged from 23 to 68 years with a mean of 48.3 years (SD 11.6). Within this cohort, 39.1% received dual-purpose PMMA CCIs (CCI PLUS), 17.4% received modified titanium mesh implants, and 43.5% received hand-molded, liquid PMMA implants with screw fixation. Total facility and/or professional charges ranged from $1978.00 to $126478.00. Average total facility charges per patient with dual-purpose CCIs were $34775.89 (SD ±â€Š$22205.09) versus $35826.00 (SD ±â€Š$23509.93) for modified titanium mesh implants and $46547.90 (SD ±â€Š81061.70) for liquid PMMA implants with screws. Mean length of inpatient stay was 5.7 days (SD = 8.1), and did not differ between implant types (P = 0.387). CONCLUSION: Temporal hollowing deformity is an expensive complication post-neurosurgery, and in the most severe form, requires a revision surgery for definitive correction. Therefore, surgeons should take further initiatives to employ reconstructive methods capable of minimizing risk for costly revision surgery, reducing morbidity related to visible deformity and accompanying social stigmata, and improving overall patient satisfaction.

Health-related quality of life with long-term retention of the PROSthesis of Antibiotic Loaded Acrylic Cement system following infection resolution in low demand patients.

BACKGROUND: The study purpose was to (1) evaluate health-related quality of life (HRQL) with the PROSthesis of Antibiotic Loaded Acrylic Cement (PROSTALAC) in situ for infected total hip arthroplasty (THA), (2) determine infection resolution, and (3) compare subjects who underwent second stage surgery with those who retained the PROSTALAC on a longer term basis. METHODS: Demographics, physical demand level, and comorbidities were recorded prospectively in 29 subjects followed to at least 24 months after initial PROSTALAC insertion. HRQL was evaluated using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and RAND 36-Item Health Survey. Infection resolution was determined using a pre-specified clinical definition. RESULTS: Twenty-five of 29 (86%) subjects' infections resolved. Three subjects died, of whom two had resolved infections. For survivors, 22/26 (85%) completed HRQL evaluations. After PROSTALAC insertion, pain and function improved within 3-6 months and was retained at 24 months. Of those followed to 24 months, 7/22 (32%) subjects underwent second stage surgery. They were higher physical demand subjects ( p = 0.03) than those not undergoing second stage surgery. We found no difference in WOMAC scores at 24 months between those who underwent second stage surgery and those who retained the PROSTALAC ( p > 0.32). DISCUSSION: The PROSTALAC system for THA appears to allow acceptable HRQL while in situ for at least 2 years in low physical demand patients. Subjects with higher physical demand levels are more likely to undergo second stage surgery. CONCLUSION: Further evaluation is required to determine whether longer term PROSTALAC retention may be appropriate for specific patient groups.

Use of a formwork in the induced membrane technique: Relevance and technical note.

The induced membrane technique is used for bone reconstruction. It is based on the osteoinductive properties of a membrane induced by the insertion of a PMMA cement spacer. We will describe a simple, cost-effective method in which the body of a syringe is used to facilitate the cement introduction, allow insertion of a regular spacer, contain the cement volume in the extension of the diaphysis and protect the underlying tissues from the exothermic reaction during PMMA polymerisation.

Polymethylmethacrylate and radioisotopes in vertebral augmentation: an explanation of underlying principles.

We recently reported a novel concept for combining radioactive isotope technology with polymethylmethacrylate (PMMA) cement used for vertebral augmentation and have advocated that pain physicians become aware of this new concept when treating malignant compression fractures. The use of vertebral augmentation for malignant compression fractures is steadily increasing, and the goal of this novel approach would be to stabilize the fractured vertebral body while also controlling proliferation of the tumor cells in the vertebral body that caused the vertebral fracture. This approach would therefore provide mechanical stabilization of the fractured vertebral body at the same time as direct targeting of the cancer cells causing the fracture. For our analysis, we investigated six specific radioisotopes with regard to physical and biologic properties as they would interact with PMMA and local bone metastatic disease, taking into consideration anatomical, biological and physical characteristics. The radioisotopes investigated include beta emitting (plus and minus) sources, as well as low energy and mid-energy photon sources and are: P-32, Ho-166, Y-90, I-125, F-18, and Tc-99m. We review the advantages and disadvantages of each radioisotope. In addition, this paper serves to provide pain physicians with a basic background of the biologic principles (Biologically Effective Dose) and statistical modeling (Monte Carlo method) used in that analysis. We also review the potential complications when using radioactive sources in a clinical setting. Understanding the methodologies employed in determining isotope selection empowers the practitioner by fostering understanding of this presently theoretical treatment option. We believe that embedding radioisotopes in PMMA is merely a first step in the road of local treatment for symptomatic local lesions in the setting of systemic disease.

Vertebral augmentation in osteoporotic fractures.

Osteoporotic vertebral compression fractures result in an enormous medical, social and economic burden to society. Here, we review osteoporotic vertebral compression fractures, focusing on both their diagnosis and the treatment options, particularly vertebral augmentation.

Vertebroplasty in osteoporotic spine fractures: a quality of life assessment.

OBJECTIVE: Our goal was to perform a quantitative evaluation of the improvement in functional capacity, quality of life, mental function, reduction in drug intake and impact on hospital admissions after vertebroplasty in the treatment of osteoporotic compression fractures. The efficacy of vertebroplasty in relief of pain has been addressed in previous publications but the quantitative evaluation of improvement in quality of life has not been addressed before. METHODS: This is a prospective study of 42 patients with 83 symptomatic vertebral fractures treated by vertebroplasty with a mean follow-up of 9.1 months. The outcome was measured by pre and postoperatively utilizing the Visual Analogue Scale, the Oswestry Disability Index, the Rolland Morris Scale for Back Pain and EuroQol-5D questionnaire (EQ-5D). The postoperative evaluations were performed at one week, one month, three month, and six month intervals thereafter. RESULTS: In 34 out of 39 active patients, marked pain relief was noted (87%). The Visual Analogue Scale score improved from a mean preoperative score of 8.2 to a mean postoperative score of 2.9 (p=0.0000003) at one week follow up and 3.9 at the last follow-up. The Rolland Morris Scale for Back Pain showed a drop from a mean preoperative rating of 13 to a mean postoperative rating of 10, showing a 25% improvement (p= 0.0207). The Oswestry Disability Index preoperatively was 64.4 which improved to 43.8 postoperatively, showing a 32% improvement (p= 0.0207). The EQ-5D showed a mean preoperative index value of 0.097 and mean postoperative index value of 0.592 (p = 0.0000003). All p-values were determined by the Willcoxin sign-ranked test. CONCLUSION: Vertebroplasty is a safe and efficacious procedure with a resulting improvement in pain and quality of life.