Aims

Oxidized zirconium (OxZi) and highly cross-linked polyethylene (HXLPE) were developed to minimize wear and risk of osteolysis in total hip arthroplasty (THA). However, retrieval studies have shown that scratched femoral heads may lead to runaway wear, and few reports of long-term results have been published. The purpose of this investigation is to report minimum ten-year wear rates and clinical outcomes of THA with OxZi femoral heads on HXLPE, and to compare them with a retrospective control group of cobalt chrome (CoCr) or ceramic heads on HXLPE.

Oxidized zirconium (Oxinium) and highly cross-linked polyethylene (HXLPE) were developed with the purpose of minimizing wear, and subsequent osteolysis, in Total Hip Arthroplasty (THA). However, few articles have been published on long-term results of Oxinium on highly cross-linked polyethylene. The purpose of this investigation is to report minimum 10-year HXLPE wear rates and the clinical outcome of patients in this group and compare this population to a control group of cobalt chrome and ceramic.

One hundred forty THAs were performed for 123 patients using an Oxinium head with an HXLPE liner. Ninety-seven had 10 years of clinical follow-up (avg. 14.5). Harris Hip Scores (HHS) were collected preoperatively and at the most recent follow-up. Radiographs of 85 hips were available for a minimum 10-year follow-up (avg. 14.5) and used to calculate wear using PolyWare software. Control groups of cobalt chrome and ceramic articulation on HXLPE with a minimum 10-year follow-up were studied.

Clinical follow-up of the Oxinium group showed a statistical improvement compared to preoperative and was similar to the control group of patients. Radiographic evaluation found the linear and volumetric wear rates for the Oxinium group of 0.03 mm/year (range 0.00–0.08) and 3.46 mm³/year (range 1.0 to 15.0) respectively. There was no statistically significant difference in linear or volumetric wear rate between the groups (P-value 0.92 and 0.55 respectively). None of these patients underwent revision of their hip for any reason.

Oxinium on highly cross-linked polyethylene has performed exceptionally with wear rates comparable to those of cobalt chrome or ceramic on HXLPE.

Aims

Highly cross-linked polyethylene (HXLPE) has greatly improved the durability of total hip arthroplasty (THA) in young patients because of its improved wear characteristics. Few studies have followed this population into the second decade, and therefore the purpose of this investigation was to evaluate the clinical outcome for THA patients 50 years of age and younger at a minimum of 15 years postoperatively. The second purpose was to evaluate the radiological findings secondary to wear or mechanical failure of the implant.

Aims

Stemmed tibial components are frequently used in revision total knee arthroplasty (TKA). The purpose of this study was to evaluate patient satisfaction, overall pain, and diaphyseal tibial pain in patients who underwent revision TKA with cemented or uncemented stemmed tibial components.

Introduction

Revision total knee arthroplasty (TKA) is becoming increasingly common in the United States as the population ages and larger numbers of primary TKA are performed in younger individuals. Cemented or uncemented tibial stems are frequently used in revision cases. Decreased clinical outcomes and patient satisfaction have been described for revision TKA. This study aims to determine if the presence of overall pain and tibial pain at the end of the stem differs between cemented and uncemented tibial stems in revision TKA.

Introduction

THA for patient's 50 years and younger is a procedure at high risk for complications and failure because of the high level of activity of this population. Highly cross linked polyethylene (HXLPE) has greatly improved the durability of the implant because of the improved wear characteristics. Few studies have followed this population into the second decade and therefore the purpose of this investigation was to evaluate the clinical outcome for the patients 5o years of age and younger at a minimum of 15 years. The second purpose was to evaluate the radiographic findings secondary to wear or mechanical failure of the implant.

Introduction

Two-stage reimplantation for prosthetic joint infection (PJI) of the hip is the standard of care with a 5–10% recurrence at a minimum two-year follow-up. Compiling outcomes data for this standard of care is necessary in order to characterize long-term reinfection risk and the culpable microbiology. The purpose of this study was to determine the long-term success of two-stage reimplantation and identify the factors that affected the success.

Introduction

Patients under the age of 50 who undergo a total hip arthroplasty (THA) are at high risk for wear-related complications due to their higher activity level. Previous studies have shown that highly crosslinked polyethylene (HXLPE) is more durable with no evidence of loosening compared to conventional polyethylene due to its improved wear characteristics. Unfortunately, there are few studies with long term follow-up of HXLPE in this patient population. The purpose of this study was to evaluate two questions related to this population of patients undergoing THA. First, what were the clinical outcomes for HXLPE in patients 50 years or younger at an average follow-up of 15 years? Second, was osteolysis observed in any of these hips?

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).

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.