Hip and knee wear simulators have been used by implant manufacturers and researchers for many years as a performance predictor and comparator for hip and knee implants. The clinical accuracy of these simulators in predicting wear depends heavily on the type of simulator as well as the methodology used. The joint lubricant used in the simulators is one crucial aspect that has been well studied in hip simulators. This study will compare the wear performance of a modern total knee replacement system using two commonly used simulator lubricants at various dilutions (Alpha Calf Serum and Bovine Calf Serum, Hyclone Labs). The Triathlon knee implant system (Stryker Orthopaedics) was used along with a six station knee wear simulator from MTS Systems to determine the effect of lubricant type and dilution. Wear rates were found to be dependent on the type and dilution of the lubricant. At 0g/L protein concentration (100% water) wear rates were 4.8mm3/million cycles (mc). With the introduction of Bovine serum, wear rates increase to a peak of 24mm3/mc at 5g/L of concentration. Increased concentration of Bovine serum resulted in a decrease of wear rates. Wear rates for Alpha serum peaked at 28mm3/mc at 20g/L concentration with decreased wear rates at higher concentrations. Knee implant wear performance is often characterized by wear simulation. As has been previously shown for hip simulations, this study shows the importance of choosing the correct lubricant type and dilution to correctly simulate wear performance. While this study cannot correlate any of the lubricants to the synovial fluid present in vivo, this study shows that 20g/L of Alpha serum produces the highest wear rates and should be used to determine worst case wear rates in the wear performance characterization of knee implants.
The results showed that in all rim supported conditions, the maximum principal stress were in compressive patterns, a preferred pattern to reduce the potential polyethylene liner fracture. In rim unsupported conditions, the stresses was in tensile on the internal bearing surface when polyethylene liner thickness was bellow 5 mm, or was bellow 9 mm if the average maximum principal stress cross the rim was considered. We conclude that the metal rim support changes the stress pattern in the rim region of UHMWPE liner to compressive for all liner thicknesses. The stress pattern turns to tensile, or there will be a higher potential for rim fracture, if UHMWPE liner is unsupported and the polyethylene rim thickness is less than 9 mm. Although components used this study did not include the locking details which add higher stress concentrations, the trend of stress patterns should follow the results found in this study.
Large and retracted rotator cuff tendon tears fail to repair, or re-tear following surgical intervention. This study attempted to develop novel tissue engineering approaches using tenocytes-seeded bioscaffolds for tendon reconstruction of massive rotator cuff tendon defect in rabbits. Porcine small intestine submucosa (Restore™) and type I/III collagen bioscaffold (ACI-MaixTM) were chosen as bioscaffold carriers for autologous tenocytes. Biological characterization of autologous tenocytes was conducted prior to the implantation. The tenocyte-seeded bioscaffolds were implanted as interposition grafts to reconstruct massive rotator cuff tendon defects in rabbits. In situ re-implantation of the autologous rotator cuff tendon, excised during defect creation served as a positive control. Histological outcomes were analysed and semi-quantitatively graded at four and eight weeks after surgery. The results demonstrate that at four weeks both tenocyte-seeded bioscaffolds display inflammatory reaction similar to bioscaffold-only cuff reconstruction and the histological grading were inferior to control repair. However, at eight weeks inflammatory reaction of both tenocyte-seeded bioscaffolds were dramatically reduced as compared to bioscaffold alone. In addition, bioscaf-folds seeded with tenocytes generated similar histological appearance to that of the positive control. The implantation of autologous tenocytes on collagen-based bioscaffold offers improved rotator cuff tendon healing and remodelling compared to the implantation of bioscaffold alone.
Remelted highly cross linked UHMWPEs have no detectable free radicals but the mechanical and fatigue properties are reduced because remelting changes the microstructure. Annealed highly cross linked UHMWPEs maintain the microstructure and mechanical properties but contain free radicals. A novel sequential irradiation and annealing process preserves the microstructure while providing enhanced oxidation resistance.
SXL density was 939.2 kg/cubic meter, identical to that for unirradiated UHMWPE and UHMWPE irradiated in nitrogen to 3 Mrad (gamma-N2). SXL crystallinity was 61.7%, compared to 61.3% and 59.2% for gamma-N2 and virgin UHMWPE, respectively. The long period spacing, crystal thickness and amorphous thickness were 38.2, 23.6 and 14.6 nm respectively for SXL and 38.9, 23.0 and 15.9 for gamma-N2. There was no statistical difference. Accelerated aging resulted in a white band for gamma-N2 with an oxidation index of 1.27. The response of SXL was the same as virgin UHMWPE e.g. crystallinity and density were unchanged with no white band formation and an oxidation index of 0.09. By avoiding remelting, sequential irradiation and annealing preserves polyethylene microstructure. The sequential process allows more efficient cross linking of free radicals resulting in an oxidation resistance equivalent to that of virgin UHMWPE.
Neutron beam irradiation is currently being explored as an alternative modality to improve local control of sarcomas. The purpose of this study was to investigate the effects of a sarcoma-dose fast neutron therapy on the wear properties of standard and highly cross-linked polyethylene total hip arthroplasty liners Two groups of 28 mm I.D. polyethylene liners were used in this study – conventional polyethylene liners (N2vac: 3Mrads innitrogen, Howmedica Osteonic, Allendale, NJ), and highly cross-linked liners (Crossfire: 10.5MRads total radiation dose, Howmedica Osteonics, Allendale, NJ). All liners were sterilized in a oxygen free environment and stored in inert nitrogen packages. The plastic cups were sandwiched between two tissue-equivalent blocks to simulate the human hip region and brought to the fast neutron therapy unit. The neutron beam is produced in a super conducting cyclotron by bombarding an internal beryllium target with 48.5 MeV deuterons [d(48.5)+BE]. The cups were exposed to a dose of 15 Gy represented a typical neutron-dose given to a sarcoma patient. Wear testing was then performed utilizing a hip simulator (MTS, EdenPrairie, MN) with matched 28 mm diameter CoCr femoral heads. Physiologic loading was simulated with biaxial cross-path motion and peak loads of 2450 N. All tests were performed in 50 percent diluted alpha-calf serum(Hyclone Laboratories, Logan, UT) to simulate human serum exposure. Every 250,000 cycles the serum was changed and samples were removed from the machine, cleaned and weighed. The volume loss measurement shown below used the weight loss to calculate the wear rate. The wear rate was converted to volume loss by dividing by the density. The value is given as millimeter scubed per million cycles (mm3/mc). Phase one cups were tested within one month of radiation. Phase two cups served as soaked controls, and spent 7months in calf serum prior to wear testing. A total of five million wear cycles were performed for each cup to simulate five years worth of use. The Averaged volumetric wear loss data demonstrated significantly less wear in CrossfireÒ compared to N2vac in both neutron irradiated and non-irradiated samples. This suggests that in sarcoma cases of the hip involving adjuvant fast neutron therapy, highly crosslinked poly-ethylene should be utilized. Averaging all data there was no statistically significant difference between the neutron radiation and non-treated components for both material conditions (N2VacÒ and CrossfireÒ). A trend towards decreasing wear in phase two samples was noted which may represent a material change in the liners exposed to serum over time. In addition, larger than normal variability in wear rates was seen within each group. Further testing of these liners is planned to elucidate these phenomenon. Table 1: – Volumetric wear loss per group. UHMWPE Material Volumetric wear Loss (mm3/mc) Standard Deviation N2VacÒ Phase 1 29.6 1.6 N2VacÒ Phase 2 14.0 N/a Neutron treated N2VacÒ Phase 1 52.2 18.1 Neutron treated N2VacÒ Phase 2 20.9 0.8 CrossfireÒ Phase 1 3.0 0.9 CrossfireÒ Phase 2 2.0 0.6 Neutron treated CrossfireÒ Phase 1 2.5 0.5 Neutron treated CrossfireÒ Phase 2 1.9 0.03 Graph 1– Averaged volumetric wear loss values Sarcoma-dose (15Gy) fast neutron therapy adversely affects the wear of standard polyethylene acetabular cups. The wear rate of the conventional gamma-inert sterilized polyethylene increased by more than 50% following a 15Gy fast neutron treatment. The highly cross-linked polyethylene (Crossfire), on the other hand, was immune to the effect of neutron treatment at the same dose. The mechanisms responsible forth is difference are unclear and warrant further investigation. The clinical implication of this study is that for sarcoma patient receiving total hip replacement, highly crosslinked poly-ethylene rather than standard polyethylene should be used for the acetabular cup.
Highly cross linked polyethylenes fall into two classes depending on whether annealing or remelting are used in processing. Annealed polyethylenes contain free radicals. Remelted polyethylenes have reduced mechanical properties but no free radicals. Research has now produced a highly cross linked polyethylene (SXL) that combines the advantages of each class. GUR 1020 polyethylene was sequentially cross linked using three separate gamma radiation doses of 3 Mrad with an annealing step at 130 degrees C after each irradiation (Mrad total). Free radical concentration was measured by electron spin resonance. Accelerated aging was carried out in an oxygen bomb under 5 atmospheres of oxygen at 70 degrees C for 14 days. Tensile properties were determined according to ASTM D638. Wear measurements to 5 million cycles were made on an MTS hip joint simulator at 1 Hz using the Paul load curve with maximum load of 2450 N with alpha fraction bovine calf serum. Free radical concentration was 14 x 10(14) spins/g for SXL compared to 1550 x 10(14)spins/g for GUR 1020 irradiated to 3 Mrad in nitrogen (gamma-N2). The maximum oxidation index was 0.09 for SXL, 0.09 for unirradiated UHMWPE, and 1.27 for gamma-N2 respectively. Mechanical properties exceeded the ASTM F648 specification and were unchanged by oxidative challenge. Wear rates were 1.35 cubic mm per million cycles for SXL and 46 cubic mm per million cycles for gamma-N2 respectively. Wear particle sizes were similar for the two materials Sequential irradiation and annealing provides more complete cross linking of free radicals with a consequent reduction in free radical level. SXL has the same resistance to oxidative challenge as unirradiated polyethylene. Mechanical properties exceed the ASTM F648 values. Wear is reduced by 97% compared to that of gamma-N2. Sequential irradiation and annealing preserves the microstructure by avoidance of melting yet minimizes free radicals.
The following were measured: free radical concentration (electron spin resonance), oxidation resistance (5 atmospheres of oxygen at 70 degrees C for 14 days), and tensile properties (ASTM D638). Hip simulator wear was determined (MTS machine, 5 million cycles, 1 Hz, Paul load curve with maximum load of 2450 N, alpha fraction bovine calf serum)
SXL tensile properties exceeded ASTM F648 and were unchanged by oxidative challenge. Wear rates were 1.35 and 46 mm3 per million cycles for SXL and gamma-N2 respectively; wear particle sizes were similar.
Wear was determined by weight loss under normal walking and stair climbing conditions (MTS knee simulator, 5 to 10 million cycles, 1 Hz, maximum load of 2600 N to 3800 N, alpha fraction bovine calf serum). Scorpio CR and PS knees were evaluated using SXL and UHMWPE gamma sterilized to 3 Mrad in nitrogen (gamma-N2). Oxidative challenge was in 5 atmospheres of oxygen at 70 degrees C for 14 days.