Migration of polyethylene particles around stable implants in an animal model.

The aim of this study was to test the hypothesis that a tight seal between bone and implant will eliminate the avenue of particle migration around stable implants. Three types of implants were used in rabbits (polished press-fit Ti-6Al-4V or plasma-sprayed hydroxyapatite [HA]-coated Ti-6Al-4V) or doughy stage polymethyl methacrylate (PMMA). Implants were placed in the condylar notch. Each animal received an intra-articular injection of high density polyethylene (PE) particles (10(8) in 0.4 mL; mean size 4.7 microns) at 4 and 6 weeks postoperatively. Eight weeks postoperatively, peri-implant tissues were examined for PE particles and osteolysis. In all cases, intracellular PE particles were seen at the bone-implant interface and within marrow. No osteolysis was observed. Bone apposition was determined by computerized image analysis. There was no significant difference in the percentage of bone apposition (+/- SD) among the three groups of implants: Ti-6Al-4V (68% +/- 19%), HA-coated Ti-6Al-4V (70% +/- 10%), and PMMA (59% +/- 12%). These results indicate that a polished Ti-6Al-4V surface is as effective as PMMA or HA coating in limiting migration of PE particles around stable osseointegrated implants in rabbits.

Fatigue strength of polyethylene after sterilization by gamma irradiation or ethylene oxide.

The oxidation level of ultrahigh molecular weight polyethylene specimens sterilized by gamma irradiation in either air or Ar gas was compared with that of unsterilized and ethylene oxide sterilized ultrahigh molecular weight polyethylene. The fatigue strength of ultrahigh molecular weight polyethylene specimens sterilized by gamma irradiation in air was compared with that of unsterilized and ethylene oxide sterilized ultrahigh molecular weight polyethylene. At the specimen surface, oxidation was highest for ultrahigh molecular weight polyethylene gamma irradiated in air, lower for ultrahigh molecular weight polyethylene gamma irradiated in Ar gas, and absent in unsterilized and ethylene oxide sterilized ultrahigh molecular weight polyethylene. At a depth of 3.5 mm below the specimen surface, oxidation levels were equivalent for ultrahigh molecular weight polyethylene gamma irradiated in either air or Ar gas whereas unsterilized and ethylene oxide sterilized specimens were again unoxidized. Thus, even in an inert atmosphere, oxidative degradation of gamma irradiated ultrahigh molecular weight polyethylene occurs. The 10 million cycle fatigue strength was similar for unsterilized and ethylene oxide sterilized ultrahigh molecular weight polyethylene whereas the fatigue strength of gamma irradiated in air ultrahigh molecular weight polyethylene was lower. Results of this study show that ethylene oxide gas does not degrade ultrahigh molecular weight polyethylene whereas gamma radiation in air causes changes in the polymer that adversely affect its mechanical properties. Ethylene oxide gas is a viable alternative to gamma radiation in air that avoids oxidation and fatigue strength degradation known to accompany irradiation of ultrahigh molecular weight polyethylene polymer bearing surfaces in total joint implants.

Safety and efficacy of ethylene oxide sterilized polyethylene in total knee arthroplasty.

Eleven unassembled metal backed patellar interfaces were inoculated with 0.1 ml of Sportol (Bacillus subtilis variety niger spore) and then assembled. Ten of the 11 implants were exposed to 1/2 of a standard ethylene oxide sterilization cycle. The remaining implant was left unsterilized as a control. All the implants were separately incubated in soybean casein digest broth for 7 days at 30 degrees to 35 degrees C and tested for positive growth of Bacillus subtilis. To measure residual ethylene oxide content, 4 ultrahigh molecular weight polyethylene tibial inserts were exposed to a full ethylene oxide sterilization cycle. The implants were removed from the sterilization chamber and tested for residual ethylene oxide at 3, 5, 8, and 9 days after sterilization using an exhaustive extraction headspace technique. Residual ethylene oxide was measured in 3 additional implants 26 days after sterilization. No growth of Bacillus subtilis occurred on any of the 10 inoculated and ethylene oxide sterilized metal backed patellar components, whereas positive growth occurred on the inoculated, unsterilized control implant. Residual ethylene oxide measured in the tibial inserts at 3, 5, 8, and 9 days after sterilization was 23, 15, 12, and 9 ppm, respectively. Twenty-six days after sterilization, residual ethylene oxide was below the minimum detectable level of the measurement technique (5 ppm).

Fatigue performance of ultra-high-molecular-weight polyethylene: effect of gamma radiation sterilization.

Ultra-high-molecular-weight polyethylene (UHMWPE) failure presents a significant materials concern in the orthopaedic community. Clinical failure following joint arthroplasty can result from the biological response to wear debris as well as structural failure owing to UHMWPE fatigue. In this study, cantilever rotating beam fatigue testing was conducted on GUR 415 UHMWPE in both the unsterilized and gamma radiation sterilized conditions. Calculations of flexural fatigue stresses were based on extreme fibre stresses and assumed negligible plastic deformation. Both material conditions exhibited similar fatigue strengths at 250,000 cycles (approximately 41 MPa) and at one million cycles (approximately 36 MPa), but a large difference developed after two million cycles. At ten million cycles, the unsterilized condition exhibited a fatigue strength of approximately 31 MPa, while the gamma-sterilized condition exhibited a reduced fatigue strength of approximately 18 MPa, an approximate decrease of 42%. High-cycle fatigue testing was necessary to fully characterize this behaviour owing to the pronounced difference in fatigue behaviour beyond two million cycles. These results suggest that gamma radiation sterilization of UHMWPE medical implants reduces their resistance to cyclic loading and, subsequently, may contribute to the associated fatigue-related failures which have been reported clinically.

Degradation potential of plasma-sprayed hydroxyapatite-coated titanium implants.

The purpose of this study was to develop an analytical method for evaluating the dissolution behavior of plasma-sprayed hydroxyapatite (HAP) coatings. Six commercially available and clinically used coatings applied to nonporous titanium coupons according to their respective specifications for orthopedic devices were used in this study. Dissolution behavior was monitored by first preconditioning the implant in 0.15 mol L-1 sodium chloride solution at 37 degrees C until either equilibrium or the desired change in solution hydrogen and calcium ion concentrations had been reached. In the second step, the implants were subjected to dual constant composition (DCC) dissolution under conditions of controlled undersaturation. Results indicate that the dissolution rates of the HAP coatings may differ by as much as a factor of 5 despite the fact that analytical techniques, including X-ray diffraction and FTIR, indicate no change in crystallinity or composition of the coatings before and after the solution treatment. These results indicate that HAP coatings from different sources react very differently when placed in the same local aqueous environment. However, more work will be necessary before these in vitro results can be used to predict in vivo behavior.

Mechanical characterization of femoral interlocking intramedullary nailing systems.

The most important mechanical characteristics of a nailing system are related to its stiffness (rigidity) and strength. This study evaluates the properties of three commercially available interlocking intramedullary nail systems using standardized test methods. An understanding of the mechanical properties along with the clinical data will assist the surgeon in choosing the optimum implant. Testing indicates that the bending strength and stiffness of the Grosse & Kempf, the AO/ASIF Universal, and the Russell-Taylor interlocking intramedullary nail designs are comparable. It is therefore not surprising that all of these nail systems have excellent clinical results. However, the nonslotted design is approximately 30 times more resistant to torsional loading than either the partially slotted design of the Grosse & Kempf nail or the fully slotted design of the AO/ASIF nail. The clinical relevance of the torsional values may not be known until a long-term comparison of the complication rates for these different systems is available. Analysis of screw design reveals a tradeoff in bending strength when compared to amount of bone purchase. The bending strength of fully threaded screws (allowing bicortical fixation) is less than that of partially threaded screws (allowing only unicortical fixation), which shows that for the implants tested, increased bone purchase requires a compromise in strength for similar sized screws.