Sub-micron polyethylene particles produced by the wear of metal on ultra-high molecular weight polyethylene (UHMWPE) in artificial joints have been identified as a principle culprit in the osteolysis frequently found in the bone surrounding these implants. To eliminate UHMWPE debris, highly crosslinked (HXL) UHMWPE and hardon-hard bearing surfaces have been developed. This study compares the wear rates of 14 designs and/or material combinations (total of 48 specimens) tested on a hip simulator in the biomechanics lab at the University of Nebraska Medical Center.

Twelve ceramic-on-metal (COM) (six 36mm and six 28mm, of high and low clearance (HC, LC)), twelve metalon-metal (MOM) (44mm, 3 TiN coated, 3 uncoated standard, and 6 resurfacing components), eighteen metal-on-UHMWPE (MOP) (36mm: six with CoCr-coated heads and six uncoated standard heads with conventional UHMWPE; 44mm: 3 conventional UHMWPE and 3 HXL), and six ceramic-on-UHMWPE (COP) (three 44mm and three 32mm all with conventional UHMWPE) were tested on a multi-station hip simulator (AMTI, Boston). The specimens were lubricated with bovine serum diluted to 20g/l protein concentration at 37°C and were subjected to the loading and rotations of the walking cycle as specified in ISO-14242-1 at 1Hz (for 5 million cycles (Mc) except where specified otherwise). The liners (and heads where specified) were cleaned and weighed at 0, 0.25, 0.5, and every 0.5Mc afterwards.

For 36mm COM liners the wear rates of HC and LC were the lowest observed (−0.019±0.118mg/Mc and −0.061±0.044mg/Mc, respectively). All three 28mm COM HC and one LC liner exhibited “break-away” wear in that they would lose several milligrams (HC: 5.99mg, 6.37mg, 8.50mg, LC: 10.22mg) after showing nearly no measurable wear (HC: 0.905±0.467mg/Mc, 28mm LC: 0.422±0.982mg/Mc). (Note that COM heads weighs were not quoted here but none of them lost weight). TiN-coated MOM THRs (heads and liners) showed higher wear than the uncoated MOM THRs (8.53±4.07mg/Mc, 3.19±0.281mg/Mc, respectively) as the TiN wore away from all three coated heads and liners. The MOM resurfacing components showed wear rates of 2.77±1.27mg/Mc over 2Mc. The 36mm MOP liners (CoCr-coated and uncoated heads) showed wear rates of 55.6±4.26mg/Mc and 44.5±4.46mg/Mc, respectively, as the coating wore away from the metal heads. Wear rates of the 44mm MOP conventional and HXL liners were 72.0±2.81mg/Mc and 14.2±3.57mg/Mc respectively. For COP, the larger size wore at a higher rate than the smaller size (44mm: 97.4±3.08mg/Mc, 32mm: 51.3±12.2mg/Mc) over 2Mc. The 44mm COP THR displayed the highest observed wear rate.

Our simulator results confirm low wear for hard-on-hard bearing couples (MOM, COM) except where coating failure had occurred. Size-36mm LC COM bearings faired the best of the four COM types tested (showing no measurable wear and no “break-away” wear). MOP THRs showed better wear performance when HXL UHMWPE was used, and also showed a sensitivity to femoral head coating removal. COP THRs showed high wear in the large 44mm size, and less in the smaller size. Simulator wear testing was able to successfully discriminate and characterize wear rates of different material bearing couples and different sizes/designs.

With the boom in metal-on-metal hip resurfacing and hard-on-hard total hip replacements (THRs) with extremely low wear, accurate tribological measurements become difficult. Characterizing THR friction can help in this, especially if the progress of such friction can be tracked during wear tests. Friction measurement can also be used as a tool to study the effects of acetabular-liner deformation during insertion, and possible femoral head “clamping”. This study presents estimates of friction during extended wear testing on THRs of the same size but with different material combinations, using a technique (previously introduced) based on equilibrium of forces and moments measured in the simulator.

All tests were based on five million cycles (Mc) and samples of size-44mm (head diameter). Samples included 6 metal-on-UHMWPE (MOP) (3 with conventional UHMWPE and 3 with highly-cross-linked (HXL) UHWMPE liners), 6 metal-on-metal (MOM) (3 TiN-coated and 3 uncoated), 6 MOM resurfacing (3 standard and 3 with small pockets for lubrication transport), and 3 ceramic-on-UHMWPE (COP) THRs (MOM resurfacing and COPs for 2Mc only). All were lubricated with diluted bovine serum with 20g/l protein concentration at 37°C, and subjected to the loading and rotations of the walking cycle in ISO-14242-1 on a twelve-station hip simulator (AMTI, Boston).

The conventional and HXL MOPs had steady friction factors of 0.045±0.009 and 0.046±0.003 over 5Mc, explained by the stability of wear rates of both these MOP types (72.0±2.81mg/Mc and 14.2±3.57mg/Mc, respectively). However, during the “bedding-in” period (first 0.5Mc), the conventional MOP friction factor rose from 0.047±0.004 to 0.057±0.004 while high wear was occurring (147.1±10.08mg/Mc). The TiN-coated and uncoated MOMs displayed initial friction factors of 0.124±0.117 and 0.039±0.003 respectively. The high standard deviation for the coated THRs was due to coating removal on one specimen which caused scratches and scuffs on its articulating surfaces. This specimen had a friction factor of 0.260 at 0.028Mc. By 1Mc, the TiN coating wore away on the other two coated specimens (friction factors at 1Mc: coated 0.081±0.036, uncoated 0.050±0.014). Over the 5Mc test, average friction factors for the coated and uncoated THRs were 0.097±0.020 and 0.049±0.014 respectively. The 44mm standard and “pocketed” MOM resurfacing THRs displayed initial friction factors of 0.038±0.009 and 0.059±0.026 respectively that increased to the same level at 2Mc (0.094±0.020 and 0.094±0.029, respectively). No difference in wear was detected between the two resurfacing head types (wear rates over 2Mc: standard 3.32±0.25mg/ Mc, pocketed 2.22±1.76mg/Mc), but curiously, both types exhibited an equal level of scratching and scuffing on their articular surface. Finally, the three COP THRs exhibited high liner wear over 2Mc (97.44±3.08mg/Mc), which slowed after the “bedding-in” period. The friction factor also decreased from 0.091±0.005 to 0.070±0.008 over the same period as the UHMWPE liner conformed to the ceramic head.

The method utilized here facilitates on-line sampling throughout the progress of a prolonged wear test, and therefore allows predictions on THR performance/wear to be made. When high friction factors were observed, a high wear rate was occurring and measured on the THR specimens, or damage to articulating surfaces was seen.

Formal surgical skill assessment and critical path analysis are not widely used in orthopaedic surgical training due to the lack of technology for objective quantification, reliability, and the discrimination insensitivity of existing methods. Current surgical skill assessment methods also require additional instrumentation, cost and time. Such problems can be overcome by a novel method that records the motion of surgical instrumentation for the purposes of documentation, surgical-skill assessment, and safety analysis. This method uses an existing computer-aided-orthopedic-surgery (CAOS) navigation system and does not compromise its functions of real-time tracking, rendering, or simulation. The stored data allows realistic playback in 3D of the complete bone cutting/refining process. This concept and its sensitivity were previously tested and validated using a robotic arm as a reliable actuator for a surgical instrument moving in controlled paths. In this study, the system was used to evaluate the surgical skills of actual orthopaedic residents in a hospital/lab setting.

Two chief orthopaedic surgery residents participated in the experiment. Each one cut all five distal cuts on four synthetic (right) femurs to accommodate the same femoral implant using NoMiss, an in-house built system for Navigated Freehand bone cutting. The motion of the surgical saw was recorded in real time by NoMiss during the whole procedure, but the real purpose of the experiment (and the recording) was not revealed to the residents until the end of all tests. Based on the data recorded by the navigation system, the following parameters were analyzed: cutting time, area-of-the-cut/time ratio, trajectory of the saw, errors in distance off the plane as well as errors in roll and pitch angles.

While no significant difference among the two subjects was found in bone cutting time (mean 531s vs. 642s, p=0.099), subject 1 (S1) was faster than subject 2 (S2) in total time, which included cutting, reshaping of the bone, and implantation (mean 719s vs. 958 s, p=0.035). Area-of-the-cut/time ratio revealed higher (not significant) proficiency for S1 compared to S2 (mean 16 mm2/s vs. 13 mm2/s, p=0.084). Nevertheless considering individual cuts, there was significant difference in the posterior chamfer cut (mean 9 vs. 5 mm2/s, p=0.015). The analysis of the trajectory of the saw showed less conservative motion (and less consistency) for S1 than for S2 (average total length of trajectory 8.6m (sd=2.1m) vs. 8.1m (sd=0.4m), as well as larger paths in between cuts (average 39% vs. 33% of the total trajectory).

The system/method was able to characterize different subjects without additional instrumentation, cost, time, awareness of or distraction to the user. Slightly better performance was detected for S1 compared to S2 presumably signifying superior skills. The main differences in this case appeared in the cutting of the chamfers, which might be considered the trickiest of the distal cuts in a navigated freehand cutting environment. A larger number of subjects with a wide level of expertise should be analyzed under similar conditions to establish quantitative acceptance limits (e.g. numerical determination for pass/fail criteria).

A tibial insert with choices in posterior slope, size, and thickness is proposed to improve ligament balancing in total knee arthroplasty. However, increasing slope, or the angle between the distal and proximal insert surfaces, will redistribute ultra-high molecular weight poly-ethylene (UHMWPE) thickness in the sagittal plane, potentially affecting wear. This study used in-vitro testing to compare UHMWPE wear for a standard cruciate-retaining (CR) tibial insert (STD) and a corresponding 6° sloped insert (SLP). Our hypothe sis was that slope variation would have little effect on wear.

Two of each style inserts were tested on an Instron-Stanmore knee simulator with a force-control regime. The gait cycle and other settings followed ISO 14243-1 & 2, except for the reference position, which was posteriorly shifted 6 mm to simulate the worst-case scenario. The STD insert was tilted 6° more than the SLP to level the articular surfaces. Wear was gravimetrically measured at intervals according to strict protocol.

No statistical difference (p=0.36) was found between wear for the STD (9.5 ±1.8 mg/Mc) and SLP (11.4 ±0.5 mg/Mc) inserts.

The overall wear rate measured was higher than previously published rates using implants similar to the STD inserts. This may relate to the shift in the reference position and the 6° slope, leading to increased shear loads. This is the first time the effect of tibial insert slope on wear has been evaluated in-vitro. When limited to 6°, wear testing suggests that al tering the tibial insert slope will have a minor effect on UHMWPE wear.

In recent years, patterned ultra-hydrophilic thin films have received attention because of their potential as bio-compatible surfaces for implants. However, mechanical properties of the studied surfaces are not sufficiently robust for the majority of applications. Via an ion-beam assisted deposition process, we have fabricated nanostructurally stabilized, pure cubic zirconia thin films possessing properties of hardness (16 GPa) and wettability, which are expected to benefit tribology and wear reduction. These transparent, zirconia coatings are maximally wettable by water and bovine calf serum, which is explained by the Wenzel model based on the nanotextured surface and surface energy.

The effect of aging on hydrophilic properties of cubic zirconia was determined by water contact angle (CA) measurements on samples stored in a laboratory environment from February of 2005 until now. Measurements for samples without any cleaning showed CA of around 90°, indicating surface adsorption of moisture, organic contaminants, and/or gases over time. A cleaning procedure consisting of sonication in organic solvents followed by calcination at temperatures ranging from 300°C to 600°C was found to effectively burn off residual organic contaminants, yielding CA about 10° to 20°. X-ray diffractometry and atomic force microscopy analysis of these samples revealed that the cleaning procedure induced no apparent changes in the crystal structure and nanotextured surface.

We conclude that the observed loss of ultra-hydrophilic properties was due to organic contaminants. Our results reveal a cleaning method for the long-term maintenance of the wettability of zirconia, making it a viable material for applications involving hard, hydrophilic surfaces, such as biomedical implants.

The steric and electrostatic complementarity of natural proteins and other macromolecules are a result of evolutionary processes. The role of such complementarity is well established in protein-protein interactions, accounting for the known protein complexes. To our knowledge, non-biological systems have not been a part of such evolutionary processes. Therefore, it is desirable to design and develop nonbiological surfaces, such as implant devices (e.g. bone growth for non-cemented fixation), that exhibit such complementarity effects with the natural proteins.

Cell attachment and spreading in vitro is generally mediated by adhesive proteins such as fibronectin and vitronectin [1]. The primary interaction between cells and adhesive proteins occurs through integrin and an RGD amino acid sequence. The adsorption of adhesive proteins plays an important role in cell adhesion and bone formation to an implant surface [1]. The ability of the implant surface to adsorb these proteins determines its aptitude to support cell adhesion and spreading and its biocompatibility. For example, the enhancement of osteoblast precursor attachment on hydroxyapatite (HA) as compared to titanium and stainless steel was related to increased fibronectin and vitronectin absorption [2].

The role of surface characteristics, such as topography, has been studied in recent years without the emergence of a comprehensive and consistent model [1]. For example, while no statistically significant influence of surface roughness on osteoblast proliferation and cell viability was detected in the study of metallic titanium surfaces [3], the TiO2 film enhances osteoblast adhesion, proliferation and differentiation upon an increase in roughness [4].

We designed and produced ceramic [5] and metallic coatings via an ion beam assisted deposition process with spatial dispersion (roughness) comparable to the size of proteins (3–20nm). Our ceramic and cobaltchrome (CoCr) coatings exhibit high hardness and contact angles with serum of 0° and 40° to 50°, respectively. Furthermore, our theoretical calculations and quantum-mechanical modeling clearly indicate that the spatial electric potential variation across our designed ceramic surfaces is comparable to the electrostatic potential variation of proteins such as fibronectin, promoting increased absorption on these surfaces. Therefore, an increase in the concentration of adhesive proteins on the designed surfaces results in the enhancement of the focal adhesion of cells. Our experimental results of the adhesion and proliferation of osteoblast-like stromal cells from mouse bone marrow indicate that our nanostructured coatings are three to five times better than growing on HA and orthopaedic grades of titanium and CoCr. Our results are consistent with the steric and electrostatic complementarity of nanostructured surfaces and adhesive proteins. This paper presents the adhesion and proliferation of osteoblast-like cells on micro-and nanostructured surfaces and provides new models describing the mechanism responsible for the enhancement of cell adhesion on nanostructured ceramic and metallic surfaces compared with orthopaedic materials.

Computer aided orthopaedic surgery (CAOS) systems aim to improve surgeons’ consistency and outcomes by providing additional information and graphics, often displayed on one or more computer screens. Experience has shown that surgeons often feel uncomfortable looking away from the patient to focus on the computer screen, and multiple methods have attempted to address this (e.g. by using head mounted and semi-transparent displays). We present a new approach, with a small touch-screen wirelessly controlled from the main CAOS computer and micro-controlled electronics all mounted on the cutting instrument and placed along the surgeon’s line of sight from the instrument to the wound. In addition, the micro-controlled system improves the patient’s safety by controlling the cutting speed of the blade (or stopping it), based on the saw’s positioning deviations from the planned cuts. The (on board the saw) computer-user interface also transmits commands to the main computer, based on commands issued on the touch screen.

The “smart” navigated saw was built by integrating a microcontroller, optical trackers, a small 4x6cm viewable touch-screen, and a surgical oscillating saw. Bidirectional wireless communication was established between the saw and a Navigated Freehand Cutting (NFC) CAOS system allowing dynamic speed control of the blade, slowing it down for smaller errors in position/alignment (relative to planned cuts), and stopping it for bigger errors and/or risk of tissue damage. The sensitivity of the correction and width of the allowed error envelope were made adjustable to cater for the individual surgeon preferences. The touch-screen on the saw provided the surgeon with a visual aid for cutting without them having to look away while simultaneously providing control of the interface settings by touch. After electronic bench tests, two orthopaedic residents prepared eight synthetic distal femurs with the NFC system and the prototype saw to accept a commonly used TKR implant.

All parts were integrated into a usable stand-alone device, with no software, hardware, or logical failure registered during the tests. The speed control responded to the established threshold errors and the preferred dynamically adjustable settings were found to be 0.5mm to 10mm of error in location and 0.5° to 10° in pitch or roll angle. The surgeons were satisfied with the user-interface for graphical guidance and system control. No significant difference in implant alignment, fit and cutting time were found compared with the standard NFC system with standard size computer monitors.

By a wireless link between a CAOS system computer and the cutting instrument (with a graphical touch display screen on board), the patient’s safety and surgeon’s visibility needs were addressed allowing the screen to be aligned with the wound. With a user interface on the saw, and automatic speed and stopping control of the cutting instrument based on navigation, the surgeon is prevented from cutting in the wrong place. This surgeon-actuated but “software cutting jig” fulfils the same functions of cumbersome autonomous or passive surgical robots with their sophisticated servo and haptic interfaces, but with startling utility bringing in the era of the modern “smart” hand-held bone cutting instruments.

Computer aided orthopaedic surgical (CAOS) technology has been around for over 20 years, and while it appears to provide better outcomes compared to conventional jigs, less than 1% of orthopaedic surgeons in USA have adopted it. This study surveyed the arguments against CAOS usage, highlighting those reasons which may continue to prevent CAOS from becoming truly widely accepted.

The survey has identified several concerns with navigation systems. For example, the pin tracts from navigation reference frames cause stress risers that increase the risk of bone fracture and soft tissue/muscle damage. Additionally, infrared trackers take footprint space (as they require line of sight access to the tracking camera), increase risk of infection, and present a potential distraction to the surgical team. With current CAOS systems, even more nstrumentation is needed than with non-navigated surgical systems, and it is arguable that navigation makes surgery more complex, requiring a knowledge of anatomic landmarks, an increased number of tasks prior to and during surgery, and an assortment of different and perhaps unfamiliar instruments. These complexities very likely result in a slow learning curve on current CAOS systems, a learning curve that is mostly not started by the majority of surgeons.

Other items of concern are the accuracy of morphed/generated bones in imageless systems (and how these models assume non-deformed anatomy), inaccuracies or distortion of the measurements (operating room lighting interfering with infrared trackers or field deformation of electromagnetic systems due to ferromagnetic instruments at the surgical site) and computer reliability. Considering the high cost (or low cost-effectiveness) of integrating CAOS into arthroplasty, and the lack of enough studies documenting truly better long term clinical results or fewer actual complications, it is evident why navigation is not yet a popular option for TKR.

As a result of the critical findings from this study, it is our view that any successful new technique/tool in surgery should make the overall procedure easier, faster, cheaper and better (or at least equally as good) as the current techniques. While robotic surgery seems to be re-emerging, we hypothesize that the next real breakthrough will come from newer more utilitarian light weight small foot print technologies actuated by surgeons themselves, with enhanced computer guidance that will allow them to reduce instrumentation, complexity, and surgical time such as navigated free-hand bone cutting. Alternative navigation technologies (e.g. UWB 3D positioning radar) where line of sight becomes less crucial, image based systems (rather than image free), artificial vision, and smart instrumentation are likely to play a major role in achieving widespread future acceptance of CAOS in TKR.

Concerns about reduced strength, fatigue resistance, and oxidative stability of highly crosslinked UHMWPE have limited the acceptance of these materials for TKR. It was hypothesized that a new crosslinked UHMWPE stabilized with vitamin E would substantially improve wear performance and resistance to oxidative degradation without compromising mechanical properties. The purpose of this study was to comprehensively test this hypothesis in vitro.

GUR1020 was machined from isostatic molded bar-stock, crosslinked with 100 kGy, and then doped with vitamin E. This material was compared to direct molded GUR1050 UHMWPE. Both materials were gamma irradiation sterilized as for clinical use. Small punch testing, crack growth rate fatigue testing and oxidation index measurements were performed on each material before and after accelerated aging. Knee simulator testing evaluated wear of each material for 5-million walking cycles. CR knees were tested on a 6-station AMTI knee simulator; PS knees were tested on two 4-station Instron-Stan-more knee simulators. Statistical differences in all metrics were evaluated for significance with ANOVA (p < 0.05).

After 4-week accelerated aging, the control material showed elevated oxidation, loss of small punch mechanical properties and decreased fatigue crack growth resistance. In contrast, the vitamin E stabilized material had minimal changes in these properties. Further, the vitamin E stabilized material exhibited 85% reduction in wear for both the CR and PS designs.

Highly crosslinked UHMWPE stabilized with vitamin E appears to be promising for use as a bearing surface in TKA.

Most navigation systems for TKR help in the alignment of bulky cutting jigs. We hypothesized that TKR bone cutting could be done free hand without cutting jigs, by navigating a bone saw directly. This would allow smaller incisions, faster recovery time and simpler procedures. The goal of this study was to evaluate the results of free-hand cutting by using in-house developed CAOS software against cuts with traditional jigs.

Experiments were carried out on the five planar cuts of the TKR distal femur, using first the conventional cutting jig and then freehand. The Freehand cutting system navigated and displayed 3D realistic models of the saw, the bone and the planes along which the blade should be orientated. Two experienced arthroplasty surgeons and one engineer performed the experiments on 18 identical synthetic femurs. Each performed one using jigs and five freehand. The experiments were timed and > 50 direct measurements were made for each (cut) bone with a computer digitizer, digital caliper and protractor to assess their quality.

Surgeon’s comments, qualitative and quantitative assessments of the cuts proved the concept’s feasibility and its encouraging potential. The engineer’s time improvement with freehand navigation has implications for easier TKR for trainee surgeons.

Knee simulators are now widely used for the determination of performance and wear durability of TKR’s. The International Standards Organisation (ISO) force-control option synchronises AP force and IE torque with flexion angle and axial force for the walking gait cycle. The force control concept subjects the same input waveforms to different TKRs, allowing them to move (and wear) as their designs dictate. It however relies on a mechanical spring based assembly to simulate the restraint effects of ligaments in AP and rotation. The contribution of this restraint mechanism depends on the stiffnesses of the four springs, and on how they are set at the neutral position. The springs can be loose with a gap, such that compression only starts (or ends) when the motion exceeds the gap. Alternatively the springs can be pre-compressed such that they never go loose.

A detailed mathematical model was developed which included the stiffnesses of the four springs, their settings (level of pre-compression or gap), and geometry of the mechanism to calculate a matrix of AP restraint force curves with AP displacement, and how these curves change with int-ext rotation superimposed. The same was done for rotational restraint with simultaneous linear displacement. Through an interactive computational interface, the families of curves for any combination of variables were repeatedly plotted and compared to published data on the contribution of particular ligaments to the laxity of the knee (eg. Fukubayashi et al. 1982) to find the optimum spring stiffnesses and gap configuration. This was done for simulation arrangements retaining ACL, PCL or both retained or resected. The results showed the behaviour of the system to be as sensitive to the gap and level of pre-compression, as to the stiffnesses of the springs. For the resected ACL retained PCL situation, the optimum we recommend is soft (7.24 N/mm) springs on the ACL side, harder (33.8 N/mm) springs on the PCL side, with a 2.5 mm gap on each side. For both ACL and PCL resected, the soft (7.24 N/mm) springs for both sides are optimum, again with a 2.5 mm gap on each.

These settings are obviously different from each other, and are different from the tests with this simulator published by different laboratories. The same settings are a pre-cursor for valid comparison of wear and kinematics.

Besides the numerous variations of TKR designs addressing fixation, wear, or specific indications, there are variations from competing design philosophies such as conformity and shape of the articulating surfaces and mobile versus fixed bearing designs. With the same resected ACL and retained PCL ligament combinations and similar surgical procedure, the subset of different implants for these very indications should be expected to produce only minor variations in kinematics. This study set out on a comprehensive series of detailed and intricately controlled in-vitro tests to examine this hypothesis. Six different posterior cruciate retaining medium size knees from different manufacturers were used. Four were fixed bearing condylar types of low to high constraint; and two mobile bearing ones which allowed rotational and translational freedom, one fully and one partially conforming. The implants were aligned according to the manufacturer’s recommendations and subjected to the same ISO force-control simulation. The kinematics captured from the averaged simulated cycles of walking showed AP displacement contained within an envelope of 4 mm for most of the stance phase. This increased with most to a maximum range of 5mm just before toe-off at the end of the stance phase. In rotation, the designs showed ranges during stance from about 2–13 degrees. The kinematics from the different implant designs were thus significantly different; a controversial answer regarding the hypothesis posed. This means the “performance” must be different between these implants if installed “ideally” on the same patient with the PCL retained. Studies are worthwhile to determine if these differences in performance are reflected in clinical functional conditions.