In Vitro Wear of a Novel Vitamin E Crosslinked Polyethylene Lumbar Total Joint Replacement.

BACKGROUND: A novel, lumbar total joint replacement (TJR) design has been developed to treat degeneration across all three columns of the lumbar spine (anterior, middle, and posterior columns). Thus far, there has been no in vitro studies that establish the preclinical safety profile of the vitamin E-stabilized highly crosslinked polyethylene (VE-HXLPE) lumbar TJR relative to historical lumbar anterior disc replacement for the known risks of wear and impingement faced by all motion preserving designs for the lumbar spine. QUESTIONS/PURPOSE: In this study we asked, (1) what is the wear performance of the VE-HXLPE lumbar TJR under ideal, clean conditions? (2) Is the wear performance of VE-HXLPE in lumbar TJR sensitive to more aggressive, abrasive conditions? (3) How does the VE-HXLPE lumbar TJR perform under impingement conditions? METHOD: A lumbar TJR with bilateral VE-HXLPE superior bearings and CoCr inferior bearings was evaluated under clean, impingement, and abrasive conditions. Clean and abrasive testing were guided by ISO 18192-1 and impingement was assessed as per ASTM F3295. For abrasive testing, CoCr components were scratched to simulate in vivo abrasion. The devices were tested for 10 million cycles (MC) under clean conditions, 5 MC under abrasion, and 1 MC under impingement. RESULT: Wear rates under clean and abrasive conditions were 1.2 ± 0.5 and 1.1 ± 0.6 mg/MC, respectively. The VE-HXLPE components demonstrated evidence of burnishing and multidirectional microscratching consistent with microabrasive conditions with the cobalt chromium spherical counterfaces. Under impingement, the wear rates ranged between 1.7 ± 1.1 (smallest size) and 3.9 ± 1.1 mg/MC (largest size). No functional or mechanical failure was observed across any of the wear modes. CONCLUSIONS: Overall, we found that that a VE-HXLPE-on-CoCr lumbar total joint replacement design met or exceeded the benchmarks established by traditional anterior disc replacements, with wear rates previously reported in the literature ranging between 1 and 15 mg/MC. CLINICAL RELEVANCE: The potential clinical benefits of this novel TJR design, which avoids long-term facet complications through facet removal with a posterior approach, were found to be balanced by the in vitro tribological performance of the VE-HXLPE bearings. Our encouraging in vitro findings have supported initiating an FDA-regulated clinical trial for the design which is currently under way.

Ceramic Wear Particles: Can They Be Retrieved In Vivo and Duplicated In Vitro?

BACKGROUND: Little is known about retrieved zirconia platelet toughened alumina (ZPTA) wear particles from ceramic-on-ceramic (COC) total hip arthroplasty. Our objectives were to evaluate clinically retrieved wear particles from explanted periprosthetic hip tissues and to analyze the characteristics of in vitro-generated ZPTA wear particles. METHODS: Periprosthetic tissue and explants were received for 3 patients who underwent a total hip replacement of ZPTA COC head and liner. Wear particles were isolated and characterized via scanning electron microscopy and energy dispersive spectroscopy. The ZPTA and control (highly cross-linked polyethylene and cobalt chromium alloy) were then generated in vitro using a hip simulator and pin-on-disc testing, respectively. Particles were assessed in accordance with American Society for Testing and Materials F1877. RESULTS: Minimal ceramic particles were identified in the retrieved tissue, consistent with the retrieved components demonstrating minimal abrasive wear with material transfer. Average particle diameter from in vitro studies was 292 nm for ZPTA, 190 nm for highly cross-linked polyethylene, and 201 nm for cobalt chromium alloy. CONCLUSION: The minimal number of in vivo ZPTA wear particles observed is consistent with the successful tribological history of COC total hip arthroplasties. Due to the relatively few ceramic particles located in the retrieved tissue, in part due to implantation times of 3 to 6 years, a statistical comparison was unable to be made between the in vivo particles and the in vitro-generated ZPTA particles. However, the study provided further insight into the size and morphological characteristics of ZPTA particles generated from clinically relevant in vitro test setups.

Bench Models for Assessing the Mechanics of Mitral Valve Repair and Percutaneous Surgery.

Rapid preclinical evaluations of mitral valve (MV) mechanics are currently best facilitated by bench models of the left ventricle (LV). This review aims to provide a comprehensive assessment of these models to aid interpretation of their resulting data, inform future experimental evaluations, and further the translation of results to procedure and device development. For this review, two types of experimental bench models were evaluated. Rigid LV models were characterized as fluid-mechanical systems capable of testing explanted MVs under static and or pulsatile left heart hemodynamics. Passive LV models were characterized as explanted hearts whose left side is placed in series with a static or pulsatile flow-loop. In both systems, MV function and mechanics can be quantitatively evaluated. Rigid and passive LV models were characterized and evaluated. The materials and methods involved in their construction, function, quantitative capabilities, and disease modeling were described. The advantages and disadvantages of each model are compared to aid the interpretation of their resulting data and inform future experimental evaluations. Repair and percutaneous studies completed in these models were additionally summarized with perspective on future advances discussed. Bench models of the LV provide excellent platforms for quantifying MV repair mechanics and function. While exceptional work has been reported, more research and development is necessary to improve techniques and devices for repair and percutaneous surgery. Continuing efforts in this field will significantly contribute to the further development of procedures and devices, predictions of long-term performance, and patient safety.

Accelerated aqueous aging simulation of in vivo oxidation for gamma-sterilized UHMWPE.

In vivo oxidation of gamma air-sterilized ultrahigh-molecular-weight polyethylene (UHMWPE) has been observed when joint replacement hip and knee components are explanted during revision surgery. The purpose of the present study was to extend a previously published accelerated aging protocol for gamma-sterilized UHMWPE. Unsterilized and gamma-sterilized GUR 1150 resin samples were aged in phosphate-buffered saline (PBS) at 40 or 50 degrees C for up to 52 weeks. Under these conditions, slower changes in oxidation index (OI) occurred than those previously observed by aging at 60 degrees C. Reduction of aging temperature below 60 degrees C also changed the kinetics of oxidation such that the aldehyde peak (1732 cm(-1)) present at higher temperature was eliminated making the ketone/carboxylic acid region (1713-1718 cm(-1)) the primary region contributing to the calculation of the OIs for each group. The oxidation profiles obtained after 52 weeks at 40 and 50 degrees C were consistent with retrievals that have undergone low oxidation, associated with maximum OI values of less than 1. Aging at 50 degrees C represents a compromise between the slower oxidation rate of in vivo temperatures and the nonphysiological kinetics of elevated temperatures in an aqueous environment. However, even at 50 degrees C over a year of in vitro aqueous aging will be necessary to reproduce the oxidation levels observed in long-term implanted acetabular retrievals. (