Introduction

Surgeons performing a total knee replacement (TKR) have two available techniques available to help them achieve the proper bone resections and ligament tension – gap balancing (GB) and measured resection (MR). GB relies on balancing ligaments prior to bony resections whereas bony resections are made based on anatomical landmarks in MR. Many studies have been done to compare the joint kinematics between the two techniques, however the results have been varied. These studies were not done with anatomically designed prostheses. The Journey II (Smith & Nephew, Memphis, TN) is one such design which attempts to mimic the normal knee joint structure to return more natural kinematics to the joint, with emphasis on eliminating both paradoxical anterior motion and reduced posterior femoral rollback. Given the design differences between anatomical and non-anatomical prostheses, it is important to investigate whether one technique provides superior kinematics when an anatomical design is used. We hypothesize that there will be no difference between the two techniques.

Introduction

Despite improvements in the survivorship of total knee replacements (TKR) over the years, patient satisfaction following TKR has not improved, with approximately 20% of patients recording dissatisfaction with their new knee joint. It is unclear why many patients feel this way, but it may relate in part to implant designs that do not provide a “natural” feeling knee. Implant manufacturers continue to introduce new concepts for implant design, which are essential for reaching the goal of a “normal” knee after TKR surgery. The Journey II TKR (Smith & Nephew) was developed with this goal in mind. Its anatomical design attempts to mimic the normal knee joint structure to return more natural kinematics to the joint, with emphasis on eliminating both paradoxical anterior motion and reduced posterior femoral rollback. Our objective is to examine patients receiving the Journey II TKR to measure the knee joint contact kinematics of the Journey II TKR compared to a non-anatomically designed implant by the same manufacturer. We hypothesize that the Journey II TKR will have more natural contact kinematics that differ from the non-anatomically designed implant.

Introduction

Reverse total shoulder arthroplasty (RTSA) is rapidly being adopted as the standard procedure for a growing number of shoulder arthropathies. Though short-term outcomes are promising, mid- and long-term follow-ups present a number of complications – among them, humeral stem and glenosphere component loosening. Though not the primary complication, previously reported aseptic loosening required revision in 100% of cases. As the number of patients undergoing RTSA increases, especially in the younger population, it is important for surgeons to identify and utilize prostheses with stable long-term fixation. It has previously been shown in the hip and knee literature that implant migration in the first two years following surgery is predictive of later failure due to loosening in the 5=10-year postoperative window. The purpose of this study is to, for the first time, evaluate the pattern and total magnitude of implant migration in reverse shoulder arthroplasty using the gold standard imaging technique radiostereometric analysis (RSA).

Introduction

Reverse total shoulder arthroplasty (RTSA) is a semi-constrained joint replacement with an articulating cobalt-chromium glenosphere and ultra-high molecular weight polyethylene (PE). Because of its limited load bearing, surgeons and implant manufacturers have not elicited the use of highly cross-linked PE in the shoulder, and to date have not considered excessive PE wear in the reverse shoulder a primary concern. As the number of shoulder procedures is expected to grow exponentially in the next decade, however, it is important to evaluate how new designs and bearing materials interact and to have an understanding of what is normal in well-functioning joint replacements. Currently, no in vivo investigation into RTSA PE wear has been conducted, with limited retrieval and simulation studies. In vitro and in silico studies demonstrate a large range in expected wear rates, from 14.3 mm³/million cycles (MC) to 126 mm³/MC, with no obvious relationship between wear rate and polyethylene diameter. The purpose of this study is to evaluate, for the first time, both volumetric and linear wear rates in reverse shoulder patients, with a minimum six-year follow-up using stereo radiographic techniques.

Introduction

Total shoulder arthroplasty is the fastest growing joint replacement in recent years, with projected compound annual growth rates of 10% for 2016 through 2021 – higher than those of both the hip and knee combined. Reverse total shoulder arthroplasty (RTSA) has gained particular interest as a solution for patients with irreparable massive rotator cuff tears and failed conventional shoulder replacement, for whom no satisfactory intervention previously existed. As the number of indications for RTSA continues to grow, so do implant designs, configurations, and fixation techniques. It has previously been shown that continuous implant migration within the first two years postoperatively is predictive of later loosening and failure in the hip and knee, with aseptic loosening of implant components a guaranteed cause for revision in the reverse shoulder. By identifying implants with a tendency to migrate, they can be eliminated from clinical practice prior to widespread use. The purpose of this study is to, for the first time, evaluate the pattern and magnitude of implant component migration in RTSA using the gold standard imaging technique radiostereometric analysis (RSA).

Background

Patient specific instrumentation (PSI) for total knee replacement (TKR) has demonstrated mixed success in simplifying the operation, reducing its costs, and improving limb alignment. Evaluation of PSI with tools such as radiostereometric analysis (RSA) has been limited, especially for cut-through style guides providing mechanical alignment. The primary goal of the present study was to compare implant migration following TKR using conventional and PSI surgical techniques, with secondary goals to examine whether the use of PSI reduces operative time, instrumentation, and surgical waste.

Background

Surgeons generally perform total knee replacement using either a gap balancing or measured resection approach. In gap balancing, ligamentous releases are performed first to create an equal joint space before any bony resections are performed. In measured resection, bony resections are performed first to match anatomical landmarks, and soft tissue releases are subsequently performed to balance the joint space. Previous studies have found a greater rate of coronal instability and femoral component lift-off using the measured resection technique, but it is unknown how potential differences in loading translate into component stability and fixation.

Adequate fixation of implant components is an important goal for all arthroplasty procedures. Aseptic loosening is one of the leading causes of revision surgery in total knee arthroplasty. Radiostereometric analysis (RSA) is an imaging technique to measure implant migration, with established migration thresholds for well-fixed, at risk, and unacceptably migrating components. The purpose of the present study was to examine the long-term fixation of a cemented titanium fixed bearing polished tibial baseplate.

Patients enrolled in a previous two-year prospective trial were recalled at ten years. All patients received a cemented, posterior-stabilised total knee replacement of the same design implanted by one of three surgeons. Of the original 35 patients, 16 were available for long-term follow-up, with one patient lost to follow-up, nine patients deceased, and a further nine patients unwilling to return to the clinic. Each patient underwent RSA imaging in a supine position using a conventional RSA protocol. Migration of the tibial component in all planes as well as maximum total point motion (MTPM) was compared between all time points (baseline, six weeks, three months, six months, one year, two years) up to the ten year follow-up visits. Outcome scores including the Knee Society Score (KSS), WOMAC, SF-12, and UCLA Activity Score were recorded.

At ten years, the mean migrations of the tibial component were less than 0.1 mm and 0.1 degree in all planes relative to the post-operative RSA exam. There was no significant difference in tibial component migration between time points. However, MTPM increased significantly over time (p = 0.002), from 0.23 ± 0.18 mm at six weeks to 0.42 ± 0.20 mm at ten years. At one year, 13 patients had an acceptable MTPM level, three patients had an ‘at risk’ level, and no patient had an ‘unacceptable’ level. No patients were revised at ten years. WOMAC and KSS were significantly improved (p < 0.0001) at the latest follow-up compared to pre-operatively, but there was no difference in SF-12. The median UCLA Activity Score at latest follow-up was six (range, two to eight).

The tibial baseplate demonstrated solid fixation at ten years. No patients had an unacceptable MTPM level at one year and no patients were revised at ten years, supporting the use of RSA to predict long-term loosening risk. The low level of tibial baseplate migration found in the present study correlates to the low rate of revision for this implant as reported in individual studies and in joint replacement registries.

Studies that have previously examined the relationship between inclination angle and polyethylene wear have shown increased wear of conventional polyethylene with high inclination angles. To date, there have been no long term in vivo studies examining the correlation between cup position and polyethylene wear with highly crosslinked polyethylene.

An institutional arthroplasty database was used to identify patients who had metal-on-highly crosslinked polyethylene primary total hip arthroplasty (THA) using the same component design with a minimum follow up of 10 years ago. A modified RSA examination setup was utilised, recreating standard anteroposterior (AP) and cross-table lateral exams in a single biplane RSA acquisition. Three dimensional head penetration was measured using the centre index method. The same radiographs were used to measure inclination angle and anteversion. Spearman correlation was used to show an association between the parameters of acetabular position and wear rate.

A total of 43 hips were included for analysis in this study. Average follow-up was 12.3 ± 1.2 years. The average linear wear rate was calculated to be 0.066 ± 0.066 mm/year. Inclination angle was not correlated with polyethylene wear rate (p=0.82). Anteversion was also not correlated with polyethylene wear rate (p=0.11). There was no statistical difference between wear rates of hips within Lewinnek's “safe zone” and those outside this “safe zone” (p=0.11). Males had a higher wear rate of 0.094 ± 0.089 mm/year compared to females with a wear rate of 0.046 ± 0.032 mm/year (p=0.045).

At long term follow up of greater than 10 years, highly cross linked polyethylene has very low wear rates. This excellent tribology is independent of acetabular position, but gender did impact wear rates. Due to the low wear rates, follow-up of even longer term is suggested to examine variables affecting wear.

The philosophy of cemented total hip arthroplasty (THA) femoral components has become polarised. At one extreme are polished, collarless, tapered devices that are expected to subside; at the other extreme are roughened, non-tapered implants with a collar designed not to subside. Radiostereometric analysis (RSA) allows the accurate measurement of implant movement and has been extensively used for measurement of the in vivo migration of implants. The degree of migration as measured by RSA during the first years after surgery has been shown to correlate with the long-term performance of cemented femoral implants. The purpose of this study was to review the two-year RSA results of two different designs of primary cemented THA stems.

Data from two previous prospective RSA trials with two-year follow-up were pooled. The first group included 36 patients who received a Spectron (Smith & Nephew, Memphis, USA) cemented stem. The second group included 13 patients who received an Exeter (Stryker, Mahwah, USA) cemented stem, and 15 patients who received a CPCS (Smith & Nephew, Memphis, USA) cemented stem. All patients underwent RSA examinations shortly post-operation, at 6 weeks, 3 months, 6 months, 1 years, and 2 years. Migration and rotation of the femoral stems was measured at each time point relative to the post-operative exam, and compared between the two groups.

There was no difference in age at surgery (Spectron 78 ± 6 years, Exeter/CPCS 77 ± 5 years, p = 0.43), BMI (Spectron and Exeter/CPCS 28 ± 5 kg/m2, p = 0.92), or percentage of male patients (Spectron 23% male, Exeter/CPCS 21% male) between the implant groups. Subsidence was significantly greater (p < 0.0001) at all time points from three months to two years for the Exeter and CPCS stems (0.94 ± 0.39 mm at two years) compared to the Spectron stem (0.05 ± 0.16 mm at two years). There was no significant difference between the stem types for medial-lateral translation (p = 0.07) or anterior-posterior translation (p = 0.49), or for anterior-posterior tilt (p = 0.15), internal-external rotation (p = 0.89), or varus-valgus rotation (p = 0.05).

Implant material, design, and surface finish are all factors in the long-term performance of cemented femoral hip implants. In this study, both femoral stem designs had a magnitude of sub-sidence that was within the limits of what is considered to be safe with respect to long-term performance. The continuous subsidence of the Exeter and CPCS stems is consistent with previous reports in the literature.

Radiostereometric analysis (RSA) has become the gold standard technique for measuring implant migration and wear following joint replacement due to its high measurement precision and accuracy. However, RSA is conventionally performed using two oblique radiographic views with the presence of a calibration cage. Thus, a second set of radiographs must be acquired for clinical interpretation, for example anterior-posterior and cross-table lateral views following total hip arthroplasty (THA). We propose a modification to the RSA setup for examining THA, in which RSA measurements are performed from anterior-posterior and lateral views, with the calibration cage images acquired separately from the patient images. The objective of the current study was to compare the accuracy and precision of the novel technique to the conventional technique using a phantom.

X-ray cassette holders were developed to enable simultaneous acquisition of anterior-posterior and cross-table lateral radiographs with the patient in a supine position in the RSA suite. A Sawbones phantom with total hip implant components was attached to a micrometer-driven stage. The femoral component was translated known distances relative to the acetabular cup in all planes, mimicking head penetration due to wear. Double RSA examinations were acquired for each increment using the traditional and novel radiograph orientations. Translations were measured from the radiographic images using RSA software. For both techniques, accuracy was calculated by comparing the measured translations to the known translation from the micrometer, and reported as the 95% confidence interval. Precision was measured by comparing the measured translations between the double exams, and reported as the standard deviation.

Accuracy was greater for the conventional technique in the inferior-superior axis (p = 0.03), greater for the novel technique in the anterior-posterior axis (p = 0.01), and equivalent in the medial-lateral axis (p = 0.06). Overall accuracy for both the conventional and novel techniques was identical at ±0.022 mm. Precision was equivalent between both techniques for the medial-lateral (p = 0.68), inferior-superior (p = 0.14), and anterior-posterior axes (p = 0.86). Overall precision for the conventional technique was ±0.127 mm and for the novel technique was ±0.095 mm.

Utilising standard clinical radiograph view angles within an RSA exam had no detrimental effect on wear measurement accuracy or precision. This reduces the barriers to implementing RSA imaging in routine follow-up of arthroplasty patients, potentially greatly increasing the numbers of patients that can have quantitative data on implant performance. Future applications can involve applying more clinically relevant radiograph view angles to RSA exams of the knee and shoulder.

The advent of highly cross-linked polyethylene has resulted in improved wear rates and reduced osteolysis with at least intermediate follow-up when compared to conventional polyethylene. However, the role of alternative femoral head bearing materials in decreasing wear is less clear. The purpose of this study was to determine in-vivo polyethylene wear rates across ceramic, Oxinium, and cobalt chrome femoral head articulations.

A review of our institutional database was performed to identify patients who underwent a total hip arthroplasty using either ceramic or oxidised zirconium (Oxinium) femoral head components on highly cross-linked polyethylene between 2008 and 2011. These patients were then matched on implant type, age, sex and BMI with patients who had a cobalt chrome bearing implant during the same time period. RSA analysis was performed using the centre index method to measure femoral head penetration (polyethylene wear). Secondary quality of life outcomes were collected using WOMAC and HHS Scores. Paired analyses were performed to detect differences in wear rate (mm/year) between the cobalt chrome cohorts and their matched ceramic and Oxinium cohorts. Additional independent group comparisons were performed by analysis of variance with the control groups collapsed to determine wear rate differences between all three cohorts.

A total of 68 patients underwent RSA analysis. Fifteen patients with a ceramic femoral head component and 14 patients with an Oxinium femoral head component along with the same number of matched patients with cobalt chrome femoral head component were included in the analysis. The time in vivo for the Oxinium (5.17 +/− 0.96 years), Oxinium matched cohort (5.13 +/− 0.72 years), ceramic (5.15 +/− 0.76 years) and ceramic matched cohort (5.36 +/− 0.63 years) were comparable. The demographics of all bearing surface cohorts were similar. The paired comparison between the Oxinium and cobalt chrome cohorts (0.33 vs. 0.29 mm/year, p=0.284) and ceramic vs cobalt chrome cohorts (0.26 vs. 0.20 mm/year, p=0.137) did not demonstrate a significant difference in wear rate. The independent groups analysis revealed a significantly higher wear rate of Oxinium (0.33 mm/year) compared to cobalt chrome (0.24 mm/year) (p = 0. 038). There were no differences in HHS and WOMAC scores between the Oxinium and cobalt chrome cohorts (HHS: p = 0.71, WOMAC: p=0.08) or the ceramic and cobalt chrome cohorts (HHS: p=0.15, WOMAC: p=023).

This study presents evidence of a greater wear rate (mm/year) of the Oxinium femoral head component compared to a cobalt chrome femoral head component. This difference was not demonstrated in the ceramic femoral head component. Despite this difference, there were no clinical differences as measured by the HHS and WOMAC. Future research should focus on factors that may contribute to the higher wear rate seen in the Oxinium cohort.