Histopathological Evaluation of Orthopedic Medical Devices: The State-of-the-art in Animal Models, Imaging, and Histomorphometry Techniques.

Orthopedic medical devices are continuously evolving for the latest clinical indications in craniomaxillofacial, spine, trauma, joint arthroplasty, sports medicine, and soft tissue regeneration fields, with a variety of materials from new metallic alloys and ceramics to composite polymers, bioresorbables, or surface-treated implants. There is great need for qualified medical device pathologists to evaluate these next generation biomaterials, with improved biocompatibility and bioactivity for orthopedic applications, and a broad range of knowledge is required to stay abreast of this ever-changing field. Orthopedic implants require specialized imaging and processing techniques to fully evaluate the bone-implant interface, and the pathologist plays an important role in determining the proper combination of histologic processing and staining for quality slide production based on research and development trials and validation. Additionally, histomorphometry is an essential part of the analysis to quantify tissue integration and residual biomaterials. In this article, an overview of orthopedic implants and animal models, as well as pertinent insights for tissue collection, imaging, processing, and slide generation will be provided with a special focus on histopathology and histomorphometry evaluation.

Straight-segment mandibulectomy: a reproducible porcine mandibular critical-size defect model.

Porcine mandibular defect models are commonly used for the preclinical evaluation of reconstruction techniques. Existing studies vary in technique, complexity, and postoperative outcomes. The procedures are complex and often described without sufficient detail. We describe in detail a simple and reproducible method for creating a critical-size mandibular defect in a porcine model. Seven hemimandibular critical size defects were created in five male Yorkshire-Landrace pigs, three with unilateral defects and two with bilateral defects. A transverse incision was made over the mandibular body. Periosteum was incised and elevated to expose the mandibular body and a critical-size defect of 30 × 20 mm created using an oscillating saw. The implant was inserted and fixed with a titanium reconstruction plate and bicortical locking screws, and the wound closed in layers with resorbable sutures. Intraoral contamination was avoided. Dentition was retained and the mental nerve and its branches preserved. The marginal mandibular nerve was not encountered during dissection. All pigs retained normal masticatory function, and there were no cases of infection, wound breakdown, haematoma, salivary leak, or implant-related complications. The procedure can be performed bilaterally on both hemimandibles without affecting load-bearing function. All pigs survived until the end point of three months. Postoperative computed tomographic scans and histology showed new bone formation, and a three-point bend test showed the restoration of biomechanical strength. Straight-segment mandibulectomy is a simple and reproducible method for the creation of critical-size mandibular defects in a porcine model, simulating a load-bearing situation.

Cost-effectiveness of a Bone-anchored Annular Closure Device Versus Conventional Lumbar Discectomy in Treating Lumbar Disc Herniations.

STUDY DESIGN: Cost-utility analysis of an annular closure device (ACD) based on data from a prospective, multicenter randomized controlled trial (RCT) OBJECTIVE.: The aim of this study was to determine the cost-effectiveness of a novel ACD in a patient population at high risk for recurrent herniation following discectomy. SUMMARY OF BACKGROUND DATA: Lumbar disc herniation patients with annular defect widths ≥6 mm are at high risk for recurrent herniation following limited discectomy. Recurrent herniation is associated with worse clinical outcomes and greater healthcare costs. A novel ACD may reduce the incidence of recurrent herniation and the associated burdens. METHODS: A decision analytical modeling approach with a Markov method was used to evaluate the cost-effectiveness of the ACD versus conventional discectomy. Health states were created by projecting visual analogue scale (VAS) onto Oswestry Disability Index (ODI). Direct costs were calculated based on Humana and Medicare 2014 claims to represent private and public payer data, respectively. Indirect costs were calculated for lost work days using 2016 US average annual wages. The incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life year (QALY) was compared to willingness-to-pay thresholds. Sensitivity analyses were also conducted. RESULTS: Patients with the ACD had less symptomatic reherniations, reoperations, and complications and gained 0.0328 QALYs within the first 2 years. Total direct medical costs for the ACD group were similar to control. When productivity loss was considered, using the ACD became $2076 cheaper, per patient, than conventional discectomy. Based on direct costs alone, the ICER comparing ACD to control equaled $6030 per QALY. When indirect costs are included, the ICER became negative, which indicates that superior quality of life was attained at less cost. CONCLUSION: For lumbar disc herniations patients with annular defects ≥6 mm, the ACD was, at 2 years, a highly cost-effective surgical modality compared to conventional lumbar discectomy. LEVEL OF EVIDENCE: 1.