Vitamin E-doped cross-linked polyethylene (VEPE) has encouraged the use of larger heads in thinner liners in total hip arthroplasty (THA). However, there are concerns about wear and mechanical failure of the thin liner, especially when metal heads are used. The aim of this randomized controlled trial was to investigate if the use of a large metal head in a thin VEPE liner would increase polyethylene wear compared with a standard 32-mm metal head and to compare periacetabular radiolucencies and patient-reported outcomes in THA. 96 candidates for uncemented THA were randomly allocated to either the largest possible metal head (36–44 mm) that could be fitted in the thinnest available VEPE liner (intervention group) or a standard 32-mm metal head (control group). The primary outcome was proximal head penetration (PHP) measured with model-based radiostereometric analysis (RSA). Secondary outcomes were periacetabular radiolucencies and patient-reported outcomes. The mid-term results of the trial at 5 years are presented. Median total PHP (interquartile range) was -0.04 mm (−0.12 to 0.02) in the intervention group and -0.03 mm (=0.14 to 0.05) in the control group (p=0.691). The rates of periacetabular radiolucencies were 1/44 and 4/42 (p=0.197), respectively. Patient-reported hip function and health-related quality of life did not differ between the groups, but participants in the intervention group reported a higher level of activity (median UCLA rank 7 vs 6, p=0.020). There were 5 revisions caused by dislocations (2), periprosthetic fracture (1), stem subsidence (1), or iliopsoas impingement (1). Large metal heads in thin VEPE liners did not increase liner wear and were not associated with liner failure 5 years after THA.
The painful hip without obvious clinical or radiographic signs of complications is a well-known scenario for surgeons. The clinical tools we have access to currently lack a dynamic test for detecting early signs of motion between implant and bone. A new software, Sectra IMA, has a potential to facilitate diagnosis of early implant loosening by analysis of paired CT exams. In clinical practise the two scans are acquired by endpoint of a possible motion, “a provocation CT”, for example maximal external and internal rotation in a CT hip examination. 20 years of research by Olivecrona and Weidenhielm is the scientific background for the technique. Early results are presented by Sandberg et al 2022. To further validate and create clinical evidence more extensive clinical studies is needed. A proposal for a multicentric, global clinical study will be presented for further discussion. A new technique for diagnosis of acetabular cup loosening using computed tomography: preliminary experience in 10 patients. Henrik Olivecrona, Lotta Olivecrona, Lars Weidenhielm, Marilyn E Noz, Jocelyn Kardos, Gerald Q Maguire Jr, Michael P Zeleznik, Peter Aspelin. Acta Orthop. 2008 Jun;79(3):346-53. doi: 10.1080/17453670710015247. Inducible displacement CT increases the diagnostic accuracy of aseptic loosening in primary total hip arthroplasty. Sandberg O, Carlsson S, Harbom E, Cappelen V, Tholén S, Olivecrona H, Wretenberg P. Acta Orthop. 2022 Oct 31;93:831-836. doi: 10.2340/17453674.2022.5240.PMID: 36314542
In metal-on-polyethylene (MoP) THA large femoral metal heads are designed to increase stability and to reduce dislocation risk. The increased head size could lead to increased taper corrosion with the release of metal ions and adverse reactions. Using blood ion measurements, we aimed to investigate the association between femoral head size and metal-ion release after MoP THA. 96 patients were enrolled at two centers and randomized to receive either a 32-mm metal head or a 36–44 mm metal head (the largest possible fitting the thinnest available polyethylene insert). Blood metal ions and PROMs (OHS, UCLA) were measured at two- and five-year follow-ups. Both 2- and 5-year median chrome, cobalt, and titanium levels were below taper corrosion indicative ion levels. At 5 years, median chrome, cobalt, and titanium levels were 0.5 μg/L (0.50–0.62), 0.24 μg/L (0.18–0.30), and 1.16 μg/L (1.0–1.68) for the 32-mm group, and 0.5 μg/L (0.5–0.54), 0.23 μg/L (0.17–0.39), and 1.30 μg/L (1–2.05) for the 36–44 mm group, with no difference between groups 5 years after the insertion of MoP THAs, we found no differences in the blood metal ion levels between 32 mm heads and 36–44 mm heads and no corrosion-related revisions. As taper corrosion can debut after 5 years, there is still a need for long-term follow-up studies on the association between head size and corrosion in MoP THA.
Periprosthetic joint infections (PJI) are challenging complications following arthroplasty. Staphylococci are a frequent cause of PJI and known biofilm producers. Reoperations for PJI of the hip or knee between 2012 and 2015 performed at Sahlgrenska University Hospital were identified. Medical records were reviewed, and clinical parameters recorded for patients whose intraoperative bacterial isolates had been stored at the clinical laboratory. Staphylococcal strains isolated from reoperations due to first-time PJI were characterised by their ability to form biofilms using the microtiter plate test. The study group included 49 patients (70 bacterial strains) from first-time PJI, whereof 24 (49%) patients had recurrent infection. Strong biofilm production was significantly associated with recurrent infection. Patients infected with strong biofilm producers had a five-fold increased risk for recurrent infection. Strong biofilm production was significantly associated with increased antimicrobial resistance and PJI recurrence. This underscores the importance of determining biofilm production and susceptibility as part of routine diagnostics in PJI. Strong staphylococcal biofilm production may have implications on therapeutic choices and suggest more extensive surgery. Furthermore, despite the increased biofilm resistance to rifampicin, results from this study support its use in staphylococcal PJI.
The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm). Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.Aims
Methods
This analysis aims to provide an update of the Level-IV Partners Arthroplasty Registry (PAR), a quality-improvement initiative and research data repository. The Harris Joint Registry was founded in 1969 and has since expanded to become the Partners Arthroplasty Registry (PAR). Today, the PAR captures data on total hip and total knee arthroplasties conducted at seven hospitals in Massachusetts. Over time, data has been sourced through independent collection at a single hospital, retrospective sourcing through the Research Patient Data Registry (RPDR), and currently through the Enterprise Data Warehouse (EDW). Various statistical methods analyzed changing trends of care provided to patients across affiliated institutions. PROMs collected in the PAR are the PROMIS Physical Function and Global Health Short Forms, the HOOS and KOOS. The registry is an associate member of ISAR and will incorporate the international implant library.Introduction
Methods
The aim of this study was to evaluate the effects of posterior tibial slope (PTS) and posterior condylar offset (PCO) on patient-reported pain and function one year after TKA. A total of 500 patients from 11 clinics in 6 countries were enrolled into a prospective, multicenter study. All patients were indicated for primary TKA for OA and received components from a single manufacturer. All liners were made from vitamin-E stabilized, highly crosslinked (95 kGy) polyethylene; 54.7% were posterior stabilized (PS) and the remaining were cruciate-retaining. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was administered at the one-year follow-up visit. The KOOS pain and activities in daily life (ADL) sub-scores were dichotomized and served as the primary outcomes. Dichotomization was done with the patient acceptable symptom state (PASS), defined by previous studies as the value of the PROM above which patients deem their state as acceptable (84.5 points for KOOS pain and 83.0 points for KOOS ADL). Plain lateral radiographs were taken and assessed for PTS (Figure 1) and PCO (Figure 2). PTS was categorized as above (excessive flexion), within (ideal), or below (extension) the safe zone of 0° − 7° of flexion. PCO increases or decreases of greater than 3mm were compared against no change (≤ 3mm). Each of the two sagittal positioning metrics was tested against the KOOS pain and ADL PASS at one year.Introduction
Methods
Within the field of arthroplasty, the use of patient-reported outcome measures (PROMs) is becoming increasingly ubiquitous in an effort to employ more patient-centered methods of evaluating success. PROMs may be used to assess general health, joint-specific pain or function, or mental health. General and joint-specific questionnaires are most often used in arthroplasty research, but the relationship between arthroplasty and mental health is less well understood. Furthermore, longitudinal reports of PROM changes after arthroplasty are lacking in the literature. Our primary aim was to quantify the improvement in general, joint-specific, and mental health PROMs following total hip arthroplasty (THA) as well as the extent of any deterioration through the 7 years follow-up. Our secondary aim was to identify predictors of clinically significant PROM decline. A total of 864 patients from 17 centers across 8 countries were enrolled into a prospective study. Patients were treated with components from a single manufacturer, which have been shown to be well-functioning in other studies. Patients completed a battery of PROMs preoperatively, and at one, three, five, and seven years post-THA. Changes in PROMs between study visits were assessed via paired tests. Postoperative trends for each PROM were determined for each subject by the slope of the best-fit line of the four postoperative data points. Significant PROM deterioration was defined as one literature-defined minimum clinically important difference over 5-years. Binary logistic regressions were used to identify independent predictors of significant decline in the EuroQol (EQ-5D) visual analogue scale (VAS) for Health State, 36-Item Short Form Survey (SF-36) physical composite summary (PCS), and SF-36 mental composite summary (MCS).Introduction
Methods
The goal of the current study was to determine if SES affects PROMs in patients treated with THA. Specifically, we sought to determine any potential differences between low and high SES patients in pre-surgical PROMs, post-surgical PROMs, and PROM improvement after surgery while controlling for any potential confounding demographic factors. Patients were selected from a clinical registry at an urban tertiary academic medical center. All patients undergoing primary THA between January 1, 2000 and April 1, 2016 were eligible for this study. During this period, patients were asked to complete the Harris Hip Score (HHS), Euro-QoL 5 Dimension (EQ-5D), 0–10 Numerical Rating Scale (NRS) Pain, 0–10 NRS Satisfaction (only given postoperatively), the Charnley Classifier, and the University of California Los Angeles (UCLA) Activity Score. To determine SES, patients were matched by zip code to corresponding median household income as reported by the United States Census Bureau. Patients were then dichotomized into low and high SES groups using 2016 median household income of $57,617 USD as a cutoff point. Statistical differences between low and high SES patients were determined for demographic factors, preoperative PROMs, postoperative PROMs, and PROM change. Non-parametric variables were tested with the Mann Whitney U test and categorical variables were tested with the Chi squared test. Multivariate models were created to determine if SES group was independently predictive of achieving a minimal clinically important improvement (MCII) in PROMs (18.0 for HHS, −2.0 for NRS Pain, and 0.92 for UCLA). As potential confounders, we tested body mass index (BMI), preoperative health state from EQ-5D visual analog scale (EQ VAS), age at surgery, preoperative Charnley class, sex, and time between PROMs.Introduction
Methods
As orthopaedics shifts towards value-based models of care, methods of evaluating the value of procedures such as a total hip arthroplasty (THA) will become crucial. Patient reported outcome measures (PROMs) can offer a meaningful way for patient-centered input to factor into the determination of value. Despite their benefits, PROMs can be difficult to interpret as statistically significant, but not clinically relevant, differences between groups can be found. One method of correcting this issue is by using a minimal clinically important improvement (MCII), defined as the smallest improvement in a PROM determined to be important to patients. This study aims to find demographic and surgical factors that are independently predictive of failing to achieve a MCII in pain and physical function at 1-year following THA. A total of 976 patients were enrolled into a prospective international, multicenter study evaluating the long-term clinical performance of two acetabular shells and two polyethylene liners from a single manufacturer. All patients consented to be followed with plain radiographs and a set of PROMs preoperatively and at 1-year after surgery. The outcomes considered in this study were achieving literature-defined MCIIs in pain and physical function at one year after THA. The MCII in pain was defined as achieving a 2-point decrease on the Numerical Rating Scale (NRS)-Pain or reporting a 1-year NRS-Pain value of 0, indicating no pain. The MCII in physical function was defined as achieving an 8.29-point increase on the SF-36 Physical Function subscore. Univariate analyses were conducted to determine if there were statistically significant differences between patients who did achieve and did not achieve a MCII. Variables tested included: demographic and surgical factors, general and mental health state, and preoperative radiographic findings such as deformity and joint space width (JSW). Significant variables were entered into a multivariable binary logistic regression. Receiver-operating characteristic (ROC) analysis was used to generate cutoff values for significant continuous variables. Youden's index was used to identify cutoff points that maximized both specificity and sensitivity.Introduction
Methods
The primary purpose of the current study was to evaluate and compare the wear properties of vitamin E-doped, highly-crosslinked PE (VEPE) and one formulation of moderately cross-linked and mechanically-annealed ultra-high molecular weight PE (ModXLPE) in patients five years after primary THA. We also sought to understand whether polyethylene wear is associated with radiographic evidence of bone resorption or with deterioration in patient-reported outcome measures (PROMs). A total of 221 patients from four international centers were recruited into a prospective RSA and clinical outcomes study. Seventy percent (76%) of patients received VEPE (vs. ModXLPE) liners, and 36% received ceramic (vs. metal) femoral heads. PROMs and radiographs were collected preoperatively and at one, two, and five years postoperatively. In addition, RSA radiographs were collected to measure PE wear. We observed similar bedding in through the one-year interval and wear through the two-year interval between the two liner types. However, there was significantly more femoral head penetration in the ModXLPE cohort compared to the VEPE cohort at the five-year follow-up (p<0.001). The only variables independently predictive of increased wear were ModXLPE (vs VEPE) liner type (β=0.22, p=0.010) and metal (vs. ceramic) femoral head type (β=0.21, p=0.013). There was no association between increased wear and radiolucency development (p=0.866) or PROMs. No patients were found to have evidence of osteolysis. At five-years postoperatively, patients treated with VEPE (vs. ModXLPE) and ceramic (vs. metal) femoral heads demonstrated decreased wear. At the longest follow-up (five years postoperatively), the wear rates for both liner groups were very low and have not led to any osteolysis or implant failures via aseptic loosening.
The Swedish Hip Arthroplasty Register started in 1979 and celebrates its 40th anniversary in 2019. The Swedish Hip Arthroplasty Register is not primarily a device register or research database; we strive to provide an overall assessment of the care provided with a multidimensional approach, and to disseminate knowledge on best practices in our network of participating hospitals. Since the inception of the register, there has been a marked change in trends and outcomes. The completeness of registrations has been 97–99% for primary THA, 93–95% for revisions, and 95–98% for HA over the last 10 years. The register contains 371,125 primary THAs, 55,893 HAs, 83,233 reoperations, and 408,110 PROM responses registered in 352,585 unique patients. All outcome measures have improved over time; primary THA has 0.71% 90-day mortality, 94.3% 10-year implant survival, and 2.2% 2-year reoperation rate. At 1-year follow up, 91% of the patients report a clinically significant pain reduction, 76% report a substantial improvement in health-related quality of life, and 89% are satisfied with the result of the operation. Moving forward, we are developing enhanced online applications for surgeons, patients and the implant industry to access real-time information. This work involves constructing a shared decision-making tool that helps clinicians assessing the future benefits and risks of THA by offering individualized outcome predictions. Further steps forward include randomized clinical trials and nested studies through the registry's platform. The trends and changes in Swedish arthroplasty practice have largely been promoted and facilitated by the register over the last 40 years.
Deep infection after THA is a devastating complication that implies major suffering for the patients and large costs for society. Reports from multiple national and regional registries show increasing incidence of deep infection. Is this a consequence of improved diagnostics, changed virulence of the causative organism, increased co-morbidity of the patients? An open database will be setup and hosted by an existing, high quality registry. All possible variables including patient demographic, detailed surgical information, bacteria/fungus characteristics, antibiotic treatment, radiographic findings and follow-up for 3 years will be collected. The incoming data will be displayed on a dashboard with continuous analyses and statistics. Any individual surgeon or hospital can report data. A board with members from the International Hip Society and the International Society of Arthroplasty Registries will supervise the process and facilitate scientific analyses from collected data.
Osteolysis secondary to ultra-high molecular weight polyethylene (UHMWPE) wear is a leading cause of late-term implant failure via aseptic loosening in patients treated with total hip arthroplasty (THA). Radiation crosslinking of UHMWPE has been shown to decrease wear. However, the resulting polymer (crosslinked-PE) has a high free radical content. Two different methods that have been used to reduce the remaining free radicals are mechanical annealing and chemical stabilization using Vitamin E, a free radical scavenger. The primary purpose of the current study was to evaluate and compare the wear properties of vitamin E-doped crosslinked-PE (VEPE) and one formulation of mechanically annealed crosslinked-PE using radiostereometric analysis (RSA) in patients five years after primary THA. We also sought to understand the association between polyethylene wear and patient-reported outcome measures (PROMs). Three-hundred and five patients from six international centers were enrolled. Seventy-six percent were treated with highly-crosslinked (95 kGy) VEPE liners, and the rest received moderately-crosslinked (50 kGy) (ModXL), mechanically annealed liners. Data was collected prospectively at one-, two-, and five-year intervals. At the 5-year follow-up, proximal femoral head penetration into the VEPE liners (median = 0.05mm (range, −0.03–1.20)) was significantly lower than the penetration into the ModXL liners (median = 0.15mm (range, −0.22–1.04)) (p<0.001). In the VEPE cohort the median proximal penetration did not increase from one- to five-year follow-up (p=0.209). In contrast, there was a significant increase in femoral head penetration for the ModXL group (p<0.001) during that same time. Multivariable regression showed that the only variable predictive of increased wear was ModXL liner type (B=0.12, p<0.001). There were no differences in PROMs between the liner groups, and there was no correlation between polyethylene wear and PROMs for the cohort as a whole. The current study is the largest analysis of polyethylene wear at five-year follow-up using the RSA technique. We observed similar bedding in through the two-year interval between the two liner types, however, there was significantly more wear in the ModXL cohort at five-years. Currently, the wear rates for both liner groups are below the osteolysis threshold and have not led to any implant failures via aseptic loosening. Continued follow-up will provide a better understanding of the association between wear rate and clinical outcomes.
The gold standard for PJI treatment comprises the use of antibiotic-loaded bone cement spacers, which are limited in their load bearing capacity[1]. Thus, developing an antibiotic-eluting UHMWPE bearing surface can improve the mechanical properties of spacers and improve the quality of life of PJI patients. In this study, we incorporated vancomycin into UHMWPE to investigate its elution characteristics, mechanical properties and its efficacy against an acute PJI in an animal model. Vancomycin hydrochloride was incorporated into UHMWPE (2 to 14%) by blending and consolidation. We studied drug elution with blocks in PBS and UV-Vis spectroscopy at 280 nm. We determined the tensile mechanical properties and impact strength [3]. We implanted osteochondral plugs in rabbits using either control UHMWPE, bone cement (40g) containing vancomycin (1g) and tobramycin (3.6g) or vancomycin-eluting UHMWPE (n=5) plugs in the patellofemoral groove of rabbits. All rabbits received a beaded titanium rod in the tibial canal. All groups received two doses of 5×107 cfu of bioluminescent Vancomycin elution increased with increasing drug loading. Vancomycin elution above MIC for 3 weeks and optimized mechanical properties were obtained at 6–7 wt% vancomycin loading in UHMWPE. In our lapine acute infection model using bioluminescent These results suggest that an antibiotic-eluting UHMWPE spacer with acceptable properties as a bearing surface could be used to treat periprosthetic joint infection in lieu of bone cement spacers and this could allow safer load bearing and a higher quality of life for the patients during treatment. In addition, this presents a safer alternative in cases where the second stage surgery for the implantation of new components is hindered.
Prospectively collected data is an important source of information subjected to change over time. What surgeons were doing in 1999 might not be the case anymore in 2016 and this change in time also applies to a number of factors related to the performance and outcome of total hip replacement. We evaluated the evolution of factors related to the patient, the surgical procedure, socio-economy and various outcome parameters after merging the databases of the Swedish Hip Arthroplasty Register, Statistics Sweden and the National Board of Health and Welfare. Data on 193,253 THRs (164,113 patients) operated between 1999 and 2012 were merged with databases including general information about the Swedish population and about hospital care. We studied the evolution of surgical volume, patient demographics, socio-economic factors, surgical factors, length of stay, mortality rate, adverse events, re-operation and revision rates and PROMs. Most patients were operated because of primary osteoarthritis and this share increased further during the period at the expense of decreasing number of patients with inflammatory OA and hip fracture. Comorbidity and ASA scores increased for each year. The share of all cemented implants has dropped from 92% to 68% with a corresponding increase of all uncemented from 2% to 16%. Length of stay decreased with about 50 percent to 4.5 days in 2012. The 30- and 90-day mortality rate dropped to 0.4% and 0.7%. Re-operation and revision rates at 2 years were lower in the more recent years. The postoperative PROMs are improving despite the preoperative pain scores getting worse. Even in Sweden, always been considered as a very conservative country with regards to hip replacement surgery, the demographics of the patients, the comorbidities and the primary diagnosis for surgery are changing. Despite these changes the outcomes like mortality, re-operations, revisions and PROMs are improving.
One of the key factors responsible for altered kinematics and joint stability following contemporary total knee arthroplasty (TKA) is resection of the anterior cruciate ligament (ACL). Therefore, retaining the ACL is often considered to be the “holy grail” of TKA. However, ACL retention can present several technical challenges, and in some cases may not be viable due to an absent or non-functional ACL. Therefore, the goal of this research was to investigate whether substitution of ACL function through an anterior post mechanism could improve kinematic deficits of contemporary posterior cruciate ligament (PCL) retaining (CR) implants. This was done using KneeSIM, a previously established dynamic simulation tool based on an Oxford-rig setup. Deep knee bend, chair-sit, stair-ascent and walking were simulated for a contemporary ACL sacrificing (CR) implant, two ACL retaining implants, and an ACL substituting and PCL retaining implant. The motion of the femoral condyles relative to the tibia was recorded for kinematic comparisons. Our results revealed that, like ACL retaining implants, the ACL substituting implant could also provide kinematic improvements over contemporary ACL sacrificing implants by reducing early posterior femoral shift and preventing paradoxical anterior sliding. Such ACL substituting implants may be a valuable addition to the armament of joint surgeons, allowing them to provide improved knee function even when ACL retention is not feasible. Further research is required to investigate this mechanism in vitro and in vivo to verify the results of the simulations, and to determine whether kinematic improvements translate into improved clinical outcomes.
Radiation cross-linking of ultrahigh molecular weight polyethylene (UHMWPE) has reduced the in vivo wear and osteolysis associated with bearing surface wear (1), significantly reducing revisions associated with this complication (2). Currently, one of the major and most morbid complications of joint arthroplasty is peri-prosthetic infection (3). In this presentation, we will present the guiding principles in using the UHMWPE bearing surface as a delivery device for therapeutic agents and specifically antibiotics. We will also demonstrate efficacy in a clinically relevant intra-articular model. Medical grade UHMWPE was molded together with vancomycin at 2, 4, 6, 8, 10 and 14 wt%. Tensile mechanical testing and impact testing were performed to determine the effect of drug content on mechanical properties. Elution of the drug was performed in phosphate buffered saline (PBS) for up to 8 weeks and the detection of the drug in PBS was done by UV-Vis spectroscopy. A combination of vancomycin and rifampin in UHMWPE was developed to address chronic infection and layered construct containing 1 mm-thick drug-containing UHMWPE in the non-load bearing regions was developed for delivery. In a lapine (rabbit) intra-articular model (n=6 each), two plug of the layered UHMWPE construct were placed in the trochlear grove of the rabbit femoral surface and a porous titanium rod with a pre-grown biofilm of bioluminescent Introduction
Materials and Methods
Dual-mobility (DM) liners provide increased range of motion and stability. However, large head diameters have been associated with anterior hip pain due to impingement with surrounding soft-tissues, particularly the iliopsoas. Further, during hip extension the liner can get trapped due to anterior soft-tissue impingement that resists rotation being imparted to the liner from posterior stem-liner contact. Over time this can cause liner rim damage, leading to intra-prosthetic dislocation of the small diameter inner head. To address this, an anatomically contoured dual mobility (ACDM) liner was designed to reduce the volume of the liner below the equator that can interact with soft-tissues The average uniaxial stiffness (350 N/mm), and average dimensions (width × thickness = 14mm × 4mm) of 10 cadaver psoas tendon samples were determined in a separate study. The iliopsoas tendon was modelled as a Yeoh hyper-elastic material, and the material constants were tuned to match the experimental uniaxial test data. Cadaver specific FEA models were created for 5 specimens (10 hips) using computed tomography (CT) scans. The implant components were modeled as being rigid relative to the iliopsoas tendon. The iliopsoas tendon was modelled as extending from its insertion point on the lesser trochanter to the psoas notch on the pelvis for hip flexion angles of −15°, 0°, 15° and 30°. Appropriately sized DM components were implanted virtually for each specimen. Once placed in its proper position, the liner was rotated about the flexion axis until it contacted the stem posteriorly to represent its orientation during hip extension (Introduction
Methods
When following patients with metal-on-metal (MoM) hip replacements, current evidence suggests that orthopaedic surgeons should avoid reliance on any single investigative tool. In 2014, guidelines for stratifying patients with MoM hip replacement into groups of low, medium, and high risk of failure based on multiple criteria were published. However, such risk stratification guidelines can be difficult to interpret due to the numerous risk factors related to MoM hip replacements. This is especially true for patients with various (high and low) risk levels for different criteria within the guidelines. The first purpose of this study was to assess if a scoring system can be applied to the current MoM guidelines. The second purpose was to test, using this scoring system, how the contemporary guidelines would classify a cohort of patients with a recalled MoM hip replacement system. The study population consisted of 1301 patients (1434 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study of a recalled MoM hip replacement system at a mean of 6.2 (range 2.4 – 11.2) years from index surgery. Eleven required scoring criteria were determined based on existing follow-up algorithm recommendations and consisted of patient factors, symptoms, clinical status, implant type, metal ion levels, and radiographic imaging results. Criteria considered ‘low’ risk were given 1 point, 2 points for ‘moderate’ risk, and 3 points for the ‘high’ risk group. Forward stepwise logistic regression was conducted to determine the minimum set of predictive variables for risk of revision and assign variable weights. The MoM risk score for each hip was then created by averaging the weighted values of each predictive variable.Introduction
Methods
Complication and revision rates have shown to be high for all metal-on-metal (MoM) bearings, especially for the ASR Hip System (ASR hip resurfacing arthroplasty (HRA) and ASR XL total hip arthroplasty (THA)). This prompted the global recall of the ASR Hip System in 2010. Many studies have previously explored the association between female gender and revision surgery MoM HRA implants; yet less research has been dedicated to exploring this relationship in MoM THA. The first purpose of this study was to assess the associations between gender and implant survival, as well as adverse local tissue reaction (ALTR), in patients with MoM THA. Secondly, we sought to report the differences between genders in metal ion levels and patient reported outcome measures (PROMs) in patients with MoM THA. The study population consisted of 729 ASR XL THA patients (820 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study at a mean of 6.4 (3–11) years from index surgery. The mean age at the time of index surgery was 60 (22–95) years and 338 were women (46%). All patients enrolled had complete patient and surgical demographic information, blood metal ion levels and PROMs obtained within 6 months, and a valid AP pelvis radiograph dating a maximum of 2 years prior to consent. Blood metal ion levels and PROMs were then obtained annually after enrollment. A sub-set of patients from a single center had annual metal artifact reduction sequence (MARS) MRI performed and were analyzed for the presence of moderate-to-severe ALTR.Introduction
Methods
Studies of metal-on-metal (MoM) hip resurfacing arthroplasty (HRA) have reported high complication and failure rates due to elevated metal ion levels. These rates were shown to be especially high for the Articular Surface Replacement (ASR) HRA, possibly due to its unique design. Associations between metal ion concentrations and various biological and mechanical factors have been reported. Component positioning as measured by acetabular inclination has been shown to be of especially strong consequence in metal ion production in ASR HRA patients, but few studies have evaluated acetabular anteversion as an independent variable. The primary objective of this study was to evaluate the associations between component orientation, quantified by acetabular inclination and anteversion, and blood metal ions. Secondly, we sought to report whether conventional safe zones apply to MoM HRA implants or if these implants require their own positioning standards. We conducted a multi-center, prospective study of 512 unilateral ASR HRA patients enrolled from September 2012 to June 2015. At time of enrollment our patients were a mean of 7 (3–11.5) years from surgery. The mean age at surgery was 56 years and 24% were female. All subjects had complete demographic and surgical information and blood metal ions. In addition, each patient had valid AP pelvis and shoot-though lateral radiographs read by 5 validated readers measuring acetabular abduction and anteversion, and femoral offset. A multivariate logistic regression was used with high cobalt or chromium (greater than or equal to 7ppb) as the dependent variable. The independent variables were: female gender, UCLA activity score, age at surgery, femoral head size, time from surgery, femoral offset, acetabular abduction, and acetabular anteversion.Introduction
Methods
48 patients (52 hips), with osteoarthritis, participated in a 5 year RSA study. Each patient received a VEPE liner, a porous titanium coated shell, and an uncemented stem with a 32mm head. Tantalum beads were inserted into the VEPE and the femur to measure head wear and stem stability using RSA. RSA and PROM follow-up was obtained postoperatively, 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks test determined if changes in penetration or migration were significant (p≤0.05).Introduction
Methods
The first highly crosslinked and melted polyethylene acetabular component for use in total hip arthroplasty was implanted in 1998 and femoral heads larger than 32mm in diameter introduced 2004. The purpose of this study was to re-assemble a previous multi-center patient cohort in order to evaluate the radiographic and wear analysis of patients receiving this form of highly crosslinked polyethylene articulating against large diameter femoral heads at a minimum of 10 years follow-up. Two centers contributed patients to this ongoing clinical study. Inclusion criteria for patients was: primary THR; femoral heads greater than 32mm; minimum 10 year follow-up. 69 hips have been enrolled with an average follow-up of 11.2 years (10–15), 32 females (50%). Wear analysis was performed using the Martell Hip Analysis software. Radiographic grading was performed on the longest follow-up AP hip films. The extent of radiolucency in each zone greater than 0.5mm in thickness was recorded along with the presence of sclerotic lines and osteolysis.Introduction
Methods
The first highly crosslinked and melted polyethylene acetabular component for use in total hip arthroplasty was implanted in 1998. Numerous publications have reported reduced wear rates and a reduction in particle induced peri-prosthetic osteolysis at short to mid-term follow-up. The purpose of this study was to re-assemble a previous multi-center patient cohort in order to evaluate the radiographic and wear analysis of patients receiving this form of highly crosslinked polyethylene articulating against 32mm femoral heads or less at a minimum of 13 years follow-up. Inclusion criteria for patients was a primary THR with femoral heads 32mm or less and a minimum 13 year follow-up. 139 hips have been enrolled with an average follow-up of 13.7 years (13–16), 80 females (57%). Wear analysis was performed using the Martell Hip Analysis software. Radiographic grading was performed on the longest follow-up AP hip films. The extent of radiolucency in each zone greater than 0.5mm in thickness was recorded along with the presence of sclerotic lines and osteolysis.Introduction
Methods
Stem revision with retention of the old cement mantle (cement-in-cement revision) in cases with an intact cement/bone interface is an appealing option. There has been an increasing use of this technique. In 2014 this cement-in- cement technique was used in 10% of all stem revisions reported to the Swedish Hip Arthroplasty Register (SHAR). We analysed the outcome of cement-in-cement stem revisions reported to the SHAR during years 2001–2014 Since 2001 1292 cement-in-cement revisions (study group), performed with a short (≤150 mm) Exeter stem (n=973) or a Lubinus stem (n=319) were reported to the SHAR. Stem revisions, using short Exeter and Lubinus stems without the use of the cement-in-cement technique (n=2893) acted as the control group in this analysis. Both groups were comparable regarding primary diagnosis. In the study group there were more females and the mean age (73 years) was 2 year older (p<0.001). The primary outcome was re-revision due to all causes (n=413). Re-revision of the stem due to all causes, infections excluded (n=212) was used as secondary outcome. Survival analysis using Kaplan-Meier was performed.Introduction
Patients/Materials & Methods
Dislocation as a primary cause of revision has been on the increase in Sweden (14% in 2014). The increasing use of Dual Mobility cups (DMC) could well be explained by the increased revision burden due to dislocation, patients undergoing revision having increased comorbidities and reports that dual articular cup designs reduce the risk of dislocation. The aim of this study was to analyze the change in utilization pattern of the dual articular designs used in acetabular revision surgery in Sweden. The short-term survival of DMC was compared to traditional designs. During years 2004–2014, 1111 (925 cemented) revisions performed with a DMC design were reported to SHAR. About half (n=426) of these cases were first time revisions performed due to dislocation. During the same time period 520 dislocations were revised for dislocation using a standard cemented cup. There was no differences regarding the age, gender and primary diagnosis (p≥0.12) between the two groups. A second cup revision for all reasons and specifically for dislocation was used as end-point. Kaplan-Meier analysis was performed.Introduction
Patients/Materials & Methods
In native knees anterior cruciate ligament (ACL) and asymmetric shape of the tibial articular surface with a convex lateral plateau are responsible for differential medial and lateral femoral rollback. Contemporary ACL retaining total knee arthroplasty (TKA) improves knee function over ACL sacrificing (CR) TKA; however, these implants do not restore the asymmetric tibial articular geometry. This may explain why ACL retention addresses paradoxical anterior sliding seen in CR TKA, but does not fully restore medial pivot motion. To address this, an ACL retaining biomimetic implant, was designed by moving the femoral component through healthy in vivo kinematics obtained from bi-planar fluoroscopy and sequentially removing material from a tibial template. We hypothesized that the biomimetic articular surface together with ACL preservation would better restore activity dependent kinematics of normal knees, than ACL retention alone. Kinematic performance of the biomimetic BCR design (asymmetric tibia with convex lateral surface), a contemporary BCR implant (symmetric shallow dished tibia) and a contemporary CR implant (symmetric dished tibia) was analyzed using KneeSIM software. Chair-sit, deep knee bend, and walking were analyzed. Components were mounted on an average bone model created from magnetic resonance imaging (MRI) data of 40 normal knees. Soft-tissue insertions were defined on the average knee model based on MRI data, and mechanical properties were obtained from literature. Femoral condyle center motions relative to the tibia were tracked to compare different implant designs.INTRODUCTION
METHODS
Infection remains a serious complication following primary total hip arthroplasty (THA). Many factors including primary diagnosis, comorbidities and duration of procedure are known to influence the rate of infection. Although the association between patient and surgical factors is increasingly well understood, little is known about the role of the prosthesis. This analysis from the Australian Registry (AOANJRR) was undertaken to determine if revision for infection varied depending on the type of bearing surface used. Three different bearing surfaces, ceramic on ceramic (CoC), ceramic on cross-linked polyethylene (CoXP) and metal on cross-linked polyethylene (MoXP) were compared. The study population included all primary THA undertaken for OA using these bearing surfaces and reported to the AOANJRR between 1999 and 2013. Kaplan-Meier survivorship curves were compiled with revision for infection as the end point. Hazard Ratios (HR) from Cox proportional hazards models were used to compare revision rates. Sub analysis examining the effect of age, gender, fixation of the femoral stem and femoral head size. To ensure there was no confounding due to differences in femoral and acetabular component selection a further analysis was undertaken which compared the three different bearings with the same stem and acetabular component combinations.Introduction
Methods
Dual Mobility (DM) implants have gained popularity for the treatment and prevention of hip dislocation, with increased stability provided by a large diameter mobile liner. However, distal regions of the liner can impinge on soft-tissues like hip capsule and iliopsoas, leading to anterior hip pain. Additionally, soft-tissue impingement may trap the mobile liner, leading to excessive loading of the liner rim, from engagement with the femoral stem, and subsequent intra-prosthetic dislocation. The hypothesis of this study was that reducing the liner profile below the equator (contoured design) can mitigate soft-tissue impingement without compromising inner-head pull-out resistance and overall hip joint stability ( The interaction of conventional and contoured liners with anterior soft-tissues was evaluated in 10 cadaveric hips (5 specimens; 2 male, 3 female; age 65 ± 10 yrs; liner diameter 42–48mm) via visual observation and fluoroscopic imaging. A metal wire was sutured to the deep fibers of the iliopsoas tendon/muscle, and metal wires were embedded in the mobile liners for fluoroscopic visualization Resistance to inner-head pull-out was evaluated via Finite Element Analysis (FEA) by simulating a full cycle of insertion of the inner head into the mobile liner and subsequent pullout. The femoral head, acetabular shell, and stem were modeled as rigid, while the mobile liner was modeled as plastically deformable. Hip joint stability was evaluated by dynamic simulations in for two dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal hip rotation; (B) Posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction. A 44 mm diameter conventional and a 44 mm contoured liner were evaluated during these tests.Introduction
Methods
Dual-mobility (DM) liners have increased popularity due to the range of motion and stability provided by these implants. However, larger head diameters have been associated with anterior hip pain, due to surrounding soft-tissue impingement, particularly the iliopsoas. To address this, an anatomically contoured dual mobility (ACDM) liner was designed by reducing the volume of the liner below the equator (Fig1). Previous cadaver studies have shown that the ACDM significantly reduces iliopsoas tenting and trapping of the liner compared to conventional designs. We created a finite element study based on previous cadaver testing to further analyze the effectiveness of the ACDM design in reducing soft-tissue impingement, specifically the tendon-liner contact pressure and the tendon stress. The finite element model was developed within COMSOL 4.3b. The psoas tendon was modelled as a Yeoh hyper-elastic Material, which uses 3 constants (c1-c3), density (1.73g/cm3) and a bulk modulus (26GPa)[Hirokawa,2000]. In a previous, separate study, the average stiffness of 10 psoas tendon samples (5 cadavers), were measured to be 339[N/mm] in the linear region with average width and thickness of 14mmX4mm. The 3 constants were tuned to match experimental uniaxial test data, and were 5[GPa], 0[Gpa], and 46[GPa] for c1, c2, and c3 respectively. The implant components were rigidly modeled relative to the psoas. Cadaver specific CT models were used to create the FEA geometry. The insertion points for the Psoas were digitally determined on the proximal end of the lesser trochanter, and the psoas notch on the pelvis for hip flexion angles of −15°, 0°, 15° and 30°. These insertion points determined the length of the psoas and its relative position to the femoral head in 3D. The specific liner size and position for each cadaver was determined by implant planning with the CT models. In this abstract, we only present data for 2 specimens (left/right hips) with 44mm conventional DM, and 44mm ACDM, matching specimen anatomy. A 500N tensile load was applied to the psoas tendon proximally to simulate moderate physiological loading, the average/max stresses and contact pressures between the psoas and the two liner designs were determined.Introduction
Methods
The large diameter mobile polyethylene liner of the dual mobility implant provides increased resistance to hip dislocation. However, a problem specific to the dual mobility system is intra-prosthetic dislocation (IPD), secondary to loss of the retentive rim, causing the inner head to dissociate from the polyethylene liner. We hypothesized that impingement of the polyethylene liner with the surrounding soft-tissue inhibits liner motion, thereby facilitating load transfer from the femoral neck to the liner and leading to loss of retentive rim over time. This mechanism of soft-tissue impingement with the liner was evaluated via cadaver experiments, and retrievals were used to assess polyethylene rim damage. Total hip arthroplasty was performed on 10 cadaver hips using 3D printed dual mobility components. A metal wire was sutured to the posterior surface (underside) of the iliopsoas, and metal wires were embedded into grooves on the outer surface of the liner and inner head to identify these structures under fluoroscopy. Tension was applied to the iliopsoas to move the femur from maximum hyperextension to 90° of flexion for the purpose of visualizing the iliopsoas and capsule interaction with the mobile liner. The interaction of the mobile liner with the iliopsoas was studied using fluoroscopy and direct visual observation. Fifteen retrieved dual mobility liners were assessed for rim edge and rim chamfer damage. Rim edge damage was defined as any evidence of contact, and rim chamfer damage was classified into six categories: impact ribs on the chamfer surface, loss of machining marks, scratching or pitting, rim deformation causing a raised lip, a rounded rim edge, or embedded metal debris.Introduction
Methods
In native knees the anterior cruciate ligament (ACL) plays a major role in joint stability and kinematics. Sacrificing the ACL in contemporary total knee arthroplasty (TKA) is known to cause abnormal knee motion, and reduced function. Hence, there is growing interest in the development of ACL retaining TKA implants. Accommodation of ACL insertion around the tibial eminence is a challenge with these designs. Therefore, a reproducible and practical test setup is necessary to characterize the strength of the ACL/bone construct in ACL retaining implants. Seminal work showed importance of loading the ACL along its anatomical orientation. However, prior setups designed for this purpose are complex and difficult to incorporate into a standardized test for wide adoption. The goal of this study was to develop a standardized and anatomically relevant test setup for repeatable strength assessment of ACL construct using basic force-displacement testing equipment. Cadaver knees were positioned with the ACL oriented along the loading axis and being the only connection between femur and tibia. 15° knee flexion was selected based on highest ACL tensions reported in literature. Therefore, the fixtures were adjusted accordingly to retain 15° knee flexion when the ACL was tensioned. The test protocol included 10 cycles of preconditioning between 6N and 60N at 1mm/s, followed by continuous distraction at 1mm/s until failure (INTRODUCTION
METHODS
Dual Mobility (DM) implants have gained popularity for the treatment and prevention of hip dislocation, with increased stability provided by a large diameter mobile insert. However, distal regions of the insert may impinge on soft tissues like the iliopsoas, leading to groin pain. Additionally, soft-tissue impingement may trap the mobile insert, leading to excessive loading of the insert rim from engagement with the femoral neck and subsequent intra-prosthetic dislocation. To address this, an Anatomically Contoured Dual Mobility (ACDM) insert with a soft-tissue friendly distal geometry was developed Fluoroscopic imaging was used to evaluate soft-tissue interaction with ACDM and conventional DM inserts in four cadaver hips (Introduction
Methods
Osteolysis caused by wear of the ultrahigh molecular weight polyethylene (UHMWPE) often leads to failure. Cross-linking improves wear, but also produces residual free radicals that decrease oxidative stability. 58 patients (64 observed hips), all with osteoarthritis, gave informed consent to participate in a 5 year RSA study. Each patient received a VEPE liner, a Regenerex™ acetabular shell, and an uncemented stem with either a 32mm or 36 mm cobalt chrome femoral head. Tantalum beads were inserted into the VEPE, the pelvic and the femoral bone to measure head penetration into the polyethylene, and shell and stem stability over time, using RSA. RSA radiographs were scheduled immediately postoperatively (up to 6 weeks) and 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks nonparametric test was used to determine if changes in penetration or migration were significant over time at p≤0.05.Introduction
Methods
In Cruciate Retaining (CR) Total Knee Arthroplasty (TKA), the Posterior Cruciate Ligament (PCL) is preserved but the Anterior Cruciate Ligament (ACL) is sacrificed. In contemporary CR implants, failure to substitute for ACL function causes abnormal knee motion, with the femur being located excessively posterior on the tibia in full extension ( The kinematics of an ACL-preserving implant, the ASCR implant, and a contemporary CR implant during deep knee bend was simulated using LifeMOD KneeSIM software (Introduction
Methods
RSA is widely accepted as a precise method to asses wear and migration early in the postoperative period. In traditional RSA, one segment defines both the acetabular shell and the polyethylene liner. However, inserting beads into the liner permits employment of the shell and liner as two separate segments, thus enabling distinct analysis of the precision of three measurement methods in determining wear and acetabular shell migration. The purpose of this The UmRSA program was used to analyze the double examinations of 51 hips to determine if there was a difference in precision among 3 measurement methods: the shell only, the liner only, and the shell + liner combined segment. Tantalum beads were inserted into the liner and pelvic bone surrounding the shell intraoperatively for the purpose of RSA. Polyethylene wear was measured using point motion of the center of the head with respect to 3 different segments: 1) liner only, 2) the shell only and, 3) shell + liner segment. Cup stability was measured by segment motion comparing the stable pelvic segment to 1) the liner segment, 2) the shell only segment, and 3) the shell + liner segment. The Wilcoxon paired signed-ranks test was used to determine differences in condition number and bead counts among the 3 measurement methods (p ≤0.05).Introduction
Methods
The ASR™ Articular Surface Replacement and ASR™ XL Metal-on-Metal systems were recalled due to high revision rates at five years. A worldwide clinical follow-up of patients was initiated. This paper summarizes current findings in South Africa (SA) in comparison with those outside SA (OSA). Patients were followed annually, or until revision, from 10 clinical centers worldwide. Data collected includes demographic, surgical, radiographic, blood metal ion levels, and patient reported outcome measures (PROM).Introduction:
Methods:
Four highly cross-linked UHWMPEs except vitamin E-stabilised explants The development of both first and second generation highly cross-linked material focused on stabilizing radiation-induced free radicals as the sole precursor to oxidative degradation; however, secondary in vivo oxidation mechanisms have been identified in both conventional and highly cross-linked UHMWPE, induced by absorbed lipids and cyclic mechanical load. Retrieval studies are reporting in vivo oxidation highly cross-linked retrievals with up to ten year in vivo durations. Preclinical aging tests did not predict these in vivo material changes. With only a decade of these materials in clinical use, retrieval studies are limited to mid-term follow-up. In vitro studies face a challenge in effectively replicating the precise in vivo conditions that lead to this loss of oxidation resistance. In this study, we bypass replicating these in vivo variables by examining surgically-retrieved components, thereby testing material that has been affectively “pre-conditioned” by their in vivo service. After a preliminary post-operative analysis, we subjected retrievals to accelerated aging tests in order to predict the extent to which their oxidative stability had been uniquely compromised in vivo.Summary
Introduction
We analysed impaction bone grafting used together with cemented or uncemented fixation in acetabular revision surgery. The overall risk for re-revision did not differ between the cemented and uncemented group. However, aseptic loosening was more common in the cemented group. Several surgical techniques address bone defects in cup revision surgery. Bone impaction grafting, introduced more than thirty years ago, is a biologically and mechanically appealing method. The primary aim of this study was to evaluate the effect of bone impaction grafting when used with uncemented and cemented fixation in cup revision surgery. Uncemented cups resting on more than 50% host bone were used as controls.Summary Statement
Background
Sequentially irradiated and annealed UHMWPE hip and knee retrievals showed subsurface Highly cross-linked polyethylene was developed to improve the wear resistance of UHMWPE bearing surfaces in total hip arthroplasty. First generation irradiated and annealed polyethylene showed high oxidation Summary
Introduction
Femoral head diameter has a major influence on stability and dislocation resistance of the hip joint after Total Hip Arthroplasty (THA). Dual Mobility (DM) implants can also reduce the risk of dislocation due the large diameter mobile liner which forms the femoroacetbular articulation. However, recent studies have shown that large head prostheses can directly impinge against native soft tissues, particularly the iliopsoas, leading to anterior hip pain. Dual mobility systems have emerged as a revision option in the treatment of failed metal on metal devices because of the high incidence of post revision instability secondary to abductor loss and need for capsulectomy. We hypothesized that an Anatomically Contoured Dual Mobility (ACDM) liner could provide joint stability while better accommodating the soft tissues surrounding the hip joint. The dislocation resistance of a 44 mm ACDM implant was compared to that of a 44 mm conventional DM liner. Both implants consisted of a 28 mm inner small diameter head and the liner was abducted to be in the worst case position for dislocation (Fig. 1). The ACDM liner was based on a 44 mm sphere with smaller radii used to contour the peripheral region below the equator of the liner. MSC Adams was used for dynamic simulations based on two previously described dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal rotation of the hip and a posterosuperior directed joint force; (B) Posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction and a posteromedial force direction (Fig. 2). Impingement-free motion (motion without neck impingement against the acetabular cup) and jump distance (head separation from acetabulum at dislocation) were measured for each implant. The acetabular cup was placed at 42.5° abduction and 19.7° anteversion, while the femoral component was anteverted by 9.75° based on published data.INTRODUCTION
METHODS
While kinematic abnormalities of contemporary TKA implants have been well established, a solution has not yet been achieved. We hypothesized that contemporary TKA implants are not compatible with normal soft-tissue function and normal knee motion. We propose a novel technique for reverse engineering advanced implant articular surfaces (biomimetic surface), by using accurate 3D kinematics of normal knees. This technique accounts for surgical placement of the implants, and allows design of tibial and femoral articular surfaces in conjunction. Magnetic resonance imaging was used to create 3D knee models of 40 normal subjects (24 male, 16 female, age 29.9 ± 9.7 years), and bi-planar fluoroscopy was used to capture 3D knee motion during a deep knee bend. These data were combined to create a 3D virtual representation of an average normal knee and its motion pathway. A TKA femoral component was mounted on the average knee, and moved through its normal kinematic pathway to carve out an articular surface from a tibial template (Fig. 1 and 2). The geometry of the resulting biomimetic tibia was compared to that of the native tibia, and a contemporary TKA tibial insert that uses the same femoral component.Introduction:
Methods:
Large diameter femoral heads have been used successfully to prevent dislocation after Total Hip Arthroplasty (THA). However, recent studies show that the peripheral region of contemporary femoral heads can directly impinge against the native soft-tissues, particularly the iliopsoas, leading to activity limiting anterior hip pain. This is because the spherical articular surface of contemporary prosthesis overhangs beyond that of the native anatomy (Fig. 1). The goal of this research was to develop an anatomically shaped, soft-tissue friendly large diameter femoral head that retains the benefits of contemporary implants. Various Anatomically Contoured femoral Head (ACH) designs were constructed, wherein the articular surface extending from the pole to a theta (θ) angle, matched that of contemporary implants (Fig. 2). However, the articular surface in the peripheral region was moved inward towards the femoral head center, thereby reducing material that could impinge on the soft-tissues (Fig. 1 and Fig. 2). Finite element analysis was used to determine the femoroacetabular contact area under peak in vivo loads during different activities. Dynamic simulations were used to determine jump distance prior to posterior dislocation under different dislocation modes. Published data was used to compare the implant articular geometry to native anatomy (Fig. 3). These analyses were used to optimize the soft-tissue relief, while retaining the load bearing contact area, and the dislocation resistance of conventional implants.Introduction:
Methods:
Dual Mobility (DM) hip implants have gained popularity for the treatment and preventions of instability. In DM implants a large diameter mobile insert matches the native femoral head size. However, studies have shown that the peripheral regions of such large diameter implants overhang beyond the native anatomy and can directly impinge against nearby soft tissues, especially the iliopsoas, leading to groin pain (Fig. 1). Soft-tissue impingement can also trap the mobile DM insert, leading to damage of its peripheral rim, which secures the small diameter inner head (Fig. 2). The goal of this research was to develop an anatomically contoured soft-tissue friendly DM insert. Various Anatomically Contoured Dual Mobility (ACDM) insert designs were constructed, wherein the outer articular surface extending from the pole to a theta (θ) angle, matched that of contemporary implants (Fig. 3). However, the articular surface in the peripheral region was moved inward towards the center, thereby reducing implant volume that could impinge on the soft tissue (Fig. 1 and Fig. 3). Finite element analyses were used to determine the insert-acetabular contact area under peak in vivo loads during different activities. Finite element analysis was also used to determine resistance to extraction of the inner head. Published data was used to compare the implant articular geometry to native anatomy. These analyses were used optimize the soft-tissue relief, while matching the load bearing contact area and the resistance to extraction of the inner head in contemporary implants.Introduction:
Methods:
Large diameter femoral heads provide increased range-of-motion and reduced dislocation rates compared to smaller diameter femoral heads. However, several recent studies have reported that contemporary large head prostheses can directly impinge against the local soft tissues leading to anterior hip pain. To address this we developed a novel Anatomically Contoured large diameter femoral Head (ACH) that maintains the profile of a large diameter femoral head over a hemispherical portion and then contours inward the distal profile of the head for soft-tissue relief. We hypothesized that the distal contouring of the ACH articular surface would not affect contact area. The impact of component placement, femoral head to acetabular liner radial clearance, and joint loading during different activities was investigated. A finite element model was used to assess the femoroacetabular contact area of a 36 mm diameter conventional head and a 36 mm ACH (Fig. 1). It included a rigid acetabular shell, plastically deformable UHMWPE acetabular liner, rigid femoral head and rigid femoral stem. The femoral stem was placed at 0°, 10° and 20° of anteversion. The acetabular shell and liner were placed in 20°, 40° and 60° of abduction and 0°, 20° and 40° of anteversion. The femoral head to acetabular liner radial clearances modeled were 0.06 mm, 0.13 mm and 0.5 mm. Three loading cases corresponding to peak in vivo loads during walking, chair sit and deep-knee bend were analyzed (Fig. 2). This allowed a range of component positions and maximum joint loads to be studied.Introduction
Methods
Dual mobility (DM) implants provide increased stability and range-of-motion through the use of a large diameter mobile liner articulating against an acetabular shell. However, recent studies have reported that such contemporary large head prostheses can directly impinge against the local soft tissues leading to anterior hip pain. To address this drawback, a novel Anatomically Contoured Dual Mobility (ACDM) liner was developed that maintains the outer spherical geometry over an approximately hemispherical portion and then contours inward the distal profile of the DM liner for soft-tissue relief. The extent of the inner profile encapsulating the small diameter head is increased to provide more coverage of the head and maintain the inner head pullout force. We hypothesized that the ACDM liner for soft-tissue relief would not affect retention of the small diameter inner head or liner-acetabular load-bearing contact area. A finite element model to evaluate head retention and contact mechanics was created with a rigid acetabular shell, a plastically deformable UHMWPE DM liner, a rigid femoral head and a rigid femoral stem. For the head retention analysis, the extent of head coverage (Fig. 1) was optimized to match the inner head pullout force of a conventional DM liner. Contact mechanics of a conventional DM and ACDM liner were analyzed at the maximum joint load of three activities: gait, deep-knee bend and chair sit. One set of simulations was completed with the mobile liner and head axes aligned and another with the axes mal-aligned so that the mobile liner rim was adjacent to the femoral stem neck and the potential area of contact was away from the mobile liner apex. This allowed a broader range of potential contact to be assessed including what was determined to be a worst-case alignment.Introduction
Methods
Contemporary Posterior Cruciate Ligament (PCL) retaining TKA implants (CR) are associated with well-known kinematic deficits, such as absence of medial pivot motion, paradoxical anterior femoral sliding, and posterior femoral subluxation at full extension. The hypothesis of this study was that a biomimetic implant, reverse engineered by using healthy knee kinematics to carve the tibial articular surface, could restore normal kinematic patterns of the knee. Kinematics of the biomimetic CR and two contemporary CR implants (A, B) were evaluated during simulated deep knee bend and chair-sit in LifeModeler KneeSIM™ software. Anteroposterior motion of the medial and lateral femoral condyle centers was measured relative to a tibial origin. The implants were mounted on an average knee model created from magnetic resonance imaging (MRI) of 40 healthy knees. The medial and lateral collateral ligaments, posterior cruciate ligament, quadriceps mechanism, and the overall capsular tension were modeled. The soft-tissue insertions were obtained from the average knee model, and the mechanical properties were obtained from literature. In vivo knee kinematics of healthy subjects from published literature was used for reference.Introduction:
Methods:
Acetabular component orientation has been linked to hip stability as well as bearing mechanics such as wear. Previous studies have demonstrated wide variations of cup placement in hip arthroplasty using conventional implantation techniques which rely upon either anatomic landmarks or the use of commercial positioning guides. Enabling technologies such as navigation have been used to improve precision and accuracy. Newer technologies such as robotic guidance have been postulated to further improve accuracy. The goal of our study was to evaluate the clinical reproducibility of a consecutive series of haptically guided THR. 119 patients at 4 centers were enrolled. All patients had preoperative CT scans for the purpose of planning cup placement in lateral opening and version using proprietary software (Mako, Ft. Lauderdale, FL). All procedures were performed using a posterolateral approach. Following bone registration, acetabular preparation and component position is performed using haptic guidance. Final implant postion is ascertained by obtaining 5 points about the rim of the acetabular component and recorded. At 6 weeks, all patients had AP and cross-table lateral radiographs which were then analyzed for cup abduction and anteversion using the Hip Analysis Suite software. The goal was to determine the variability between desired preoperative plan, intraoperative measurement and postoperative results.Introduction:
Methods:
Acetabular cup position is an important factor in successful total hip arthroplasty (THA). Optimal cup placement requires surgeons to possess an accurate perception of pelvic orientation during cup impaction, however, varying pelvic anatomy and limited visual cues in the surgical field may interfere with this process. The purpose of this study was to evaluate the utility of an inertial measurement unit (IMU) in monitoring pelvic position during THA. Ten patients scheduled to undergo THA were IRB-approved and consented by four surgeons. A small IMU was placed over the patient's sacrum pre-operatively and zeroed in standing position. Pelvic orientation data was streamed and captured wirelessly throughout the procedure. Surgeons were blinded to all data throughout the study period. Prior to cup impaction, the surgeon indicated his intended cup abduction angle and the degree to which the cup impactor was manipulated to compensate for perceived AP pelvic tilt. The degree of pelvic tilt as determined by the IMU (angle β) was then recorded (Figure 1). AP-pelvis radiographs were measured in Martell Hip Analysis Suite post-operatively to calculate the cup abduction angle, which was then compared to the surgeon's intended abduction angle to determine surgeon accuracy. To predict the final cup abduction angle, the degree of pelvic tilt recorded by the IMU (angle β) was subtracted from the abduction angle of the cup impactor (angle α) that was positioned using the OR table as a reference (Figure 1). This value was then compared to the measured post-operative cup abduction angle in order to assess the accuracy of the IMU in measuring pelvic tilt. Surgeon accuracy and IMU accuracy were compared to determine if the IMU was more or less effective than surgeon perception at determining pelvic tilt.Introduction:
Materials & Methods:
Femoral head diameter has a major influence on stability and dislocation resistance after Total Hip Arthroplasty (THA). Although routine use of large heads is common, several recent studies have shown that contemporary large head prostheses can directly impinge against native soft tissues, particularly the iliopsoas which wraps around the femoral head, leading to refractory anterior hip pain. To address this, we developed a novel Anatomically Contoured large diameter femoral Head (ACH). We hypothesized that anatomical contouring of the ACH implant for soft tissue relief would not compromise dislocation resistance, and the ACH implant would provide increased stability compared to small heads. In this study the dislocation resistance of a 36 mm ACH was compared to that of 28 mm and 36 mm contemporary heads. The ACH implant was based on a 36 mm sphere with smaller radii used to contour the peripheral region below the equator of the head. MSC Adams was used for dynamic simulations based on two previously described dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal rotation of the hip and a posterosuperior directed joint force; (B) posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction and a posteromedial force direction (Fig. 1). Impingement-free motion (motion without neck impingement against the acetabular liner) and jump distance (head separation from acetabulum prior to dislocation) were measured to evaluate the dislocation risk of each implant. The acetabular cup was placed at 42.5° abduction and 19.7° anteversion, while the femoral component was anteverted by 9.75° based on published data.INTRODUCTION
METHODS
In total hip arthroplasty, the positioning of the acetabular cup, in particular, has been shown to play an important role in the survivorship of the prosthetic joint. The commonly accepted “safe zone” extends from 5–30° of anteversion to 30–50° of inclination. However, several studies have utilized a more restrictive safe zone of 5–25° of anteversion and 30–45° of inclination, a modification of the Lewinnek zone. Many attempts have been made to develop a more reliable method of positioning the acetabular component. Robotic-assisted surgery is one such method. The purpose of this study was to compare the resulting position of the acetabular component after robotic-assisted surgery with the intraoperative robotic data to determine if improved accuracy can be achieved with the robotic-assisted method. One hundred and nineteen patients received THA, at four different medical centers in the United States, using a haptic robotic arm. Pre-operative CT scans were obtained for all patients and used during the planning of the procedure, at which point the proposed component size and positioning was determined. Preparation of the acetabular bone bed, as well as impaction of the acetabular component itself, was performed using the robotic device. Using an AP Pelvis and Cross-Table Lateral radiograph, each patient's resulting acetabular inclination and version was measured using the Hip Analysis Suite software. The component position retrieved from the robot was compared to the measured values from the radiographs. The positioning data was compared to two safe zones described above.Introduction
Methods
Proper cup positioning is a critical component in the success of total hip arthroplasty surgery. A multicenter study has been initiated to study a new type of highly cross-linked polyethylene. This study provides a unique opportunity to a review the acetabular cup placement of over 500 patients implanted in the past 2 years from 13 medical centers from the U.S., Mexico, and Europe. 482 patients have received primary total hip arthroplasty using components from a single manufacturer in 5 centers in the US and Mexico and 7 centers in Europe. The acetabular anteversion and inclination were measured in post-operative radiographs. An acceptable window of cup position is defined at 5–25° of anteversion and 30–45° of inclination.Introduction
Methods
Total hip replacements using highly cross-linked polyethylene show excellent clinical outcomes, low wear, and minimal lysis at 5 years follow-up. A recent RSA study reports a significant increase in femoral head penetration between 5 and 7 years. This study is a multi-center radiographic analysis to determine whether the RSA observation is present in a large patient cohort. Six centers were enrolled for radiographic analysis of primary total hip arthroplasty for standard head sizes (26mm, 28mm, or 32mm). Radiographic inclusion criteria required a minimum of four films per patient at the following time points: 1 year; 2–4.5 years; 4.5–5.5 years; and 5.5–11 years. The Martell Hip Analysis Suite was used to analyze pelvic radiographs resulting in head penetration values. Wear rates were determined in two ways: the longest follow-up radiograph compared to the 1 year film, and individual linear regressions for the early and late periods. For both methods, average wear rates from the early period (1 to 5.5 years) and late period (>5.5 years) were compared using t-tests.Introduction
Methods
Acetabular cup positioning has been linked to dislocation and increased bearing surface wear. A previous study found correlations between patient and surgical factors and acetabular component position. The purpose of this study was to determine if acetabular cup positioning improves when surgeons receive feedback on their performance. Post-op anteroposterior (AP) pelvis and cross-table lateral radiographs were previously obtained for 2061 patients who received a total hip arthroplasty (THA) or hip resurfacing from 2004–2008. The surgeries were performed by 7 surgeons. AP radiographs were measured using Hip Analysis Suite to calculate the cup inclination and version angles. Acceptable ranges were defined for abduction (30–45 °) and version (5–25 °). The same surgeons performed a THA or hip resurfacing on 385 patients from January 2009 through June 2010. Cup inclination and version angles for this set of surgeries were compared to surgeries from 2004–2008 to determine if cup inclination and version angles improved in response to previous acetabular cup positioning studies. Improvement in accuracy was assessed by the chi-square test.Introduction
Methods
Radiation crosslinking decreases the wear of ultra-high molecular weight polyethylene (UHMWPE) and subsequent heating increases its oxidative stability. Clinical trials are showing lower femoral head penetration rate with highly crosslinked vs. conventional UHMWPE liners. Recently, a follow-up report showed a surprising increase in the femoral head penetration rate with a highly crosslinked UHMWPE, prompting us to closely analyze surgically explanted highly crosslinked UHMWPEs. Thirty-four highly crosslinked components, all irradiated (100kGy) and melted, were included in the study. The components were surgically removed from patients for non-polyethylene related reasons. Oxidation was determined at the rim immediately after explantation. After shelf storage in air for 5–77 months, oxidation and crosslink density were measured at the rim and articular surfaces. An additional retrieval (92 mos. in vivo) was tested on the hip simulator; oxidation and crosslink density were determined after simulator testing. All components showed no detectable oxidation immediately after explantation; however, surprisingly oxidation levels increased during shelf storage. Areas with increased oxidation showed a decrease in crosslink density. These changes did not correlate with in vivo duration; however, they correlated strongly with ex vivo duration. The component subjected to hip simulator testing showed no measurable wear and showed no detectable oxidation or marked decrease in crosslink density. Two mechanisms may have reduced the oxidation resistance of highly crosslinked UHMWPE upon exposure to in vivo elements and subsequent exposure to air. One mechanism is based on free radical formation during cyclic loading; the other is based on an oxidation cascade initiated by absorbed lipids. Further studies are necessary to determine the impact of these mechanisms, if any, on the stability of components during in vivo service.
There are a variety of patient and surgical factors shown to increase post-operative complication risk for a total hip arthroplasty (THA). While many studies have linked patient and surgical factors to unsuccessful outcomes post total hip arthroplasty (THA), no study has attempted to correlate the infiuence of these factors to the positioning of the acetabular cup. The purpose of this study was to determine if a correlation exists between patient and surgical factors and the anatomical position of the acetabular component. Data for 2063 patients from 2004–2008 who underwent a primary total hip arthroplasty (THA), revision THA, or Birmingham Hip Resurfacing procedure was compiled. The post- op anteroposterior pelvis (AP) and the cross table lateral digital radiographs for each patient were measured to determine cup inclination and version. Acceptable angle ranges were defined as 30–45° for abduction, and 5–25° for version. Correlations between variables and cup abduction and version angles were determined with SPSS™ statistical software. There were 1954(95%) qualifying patients. There were 1218(62%) acetabular cups that fell within the 30–45° optimal abduction range, and 1576(87%) cups in the 5–25° optimal version range. There were 921(47%) patients that had both inclination and version angles that fell within the optimal range. Regression analysis showed that surgical approach (p>
0.001), high/low volume surgeon (p<
0.001), and obesity (BMI >
30, p=0.01) were independent predictors for abduction and version combined analysis. Both surgical approach (p<
0.001) and BMI (p=0.018) were independent predictors in the individual analysis of both abduction and version. High/low volume surgeon was significant for the independent analysis of abduction (p=0.013). In the combined analysis, low volume surgeons showed a 2 fold increase (95% C.I. 1.5–2.8) in risk for cup malpositioning compared to high volume surgeons. The MIS surgical approach showed a 6 fold increase (95% C.I. 3.5–10.7) in risk for cup malpositioning compared to the posterolateral approach. Obesity (BMI>
30) showed a 1.3 fold increase (95% C.I. 1.1–1.7) in risk for cup malpositioning compared to all other body mass index groups. Posterolateral surgical approach was superior to MIS surgical approaches for independent and combined abduction and version analysis. High volume surgeons had greater accuracy for cup positioning, specifically for achieving optimal cup abduction angle. Compared to all other body mass index categories, patients that were obese (BMI>
30) displayed a greater risk for cup malpositioning for independent and combined abduction and version analysis. Further statistical analyses on patient and surgical variables and their infiuence on cup position at a lower volume medical center would provide a valuable data comparison.
The purpose of this study was to organize a multicenter radiographic study involving leading medical centers in the U.S. having the longest-term follow-up available on this type of highly cross-linked polyethylene in order to determine if the RSA observation can be confirmed in a larger study. Six academic centers agreed to contribute radiographic data to this study. All patients received primary total hip replacements with Longevity polyethylene liners (Zimmer, Warsaw, IN) coupled with 26, 28, and 32mm cobalt chrome femoral heads. The radiographic inclusion criteria required a minimum of four radiographs per patient: one at 1 year; at least one from 2 to 4.5 years; one 4.5 to 5.5 years; and at least one from 5.5 to 9 years follow-up. The Martell Hip Analysis Suit-eTM software was used for the wear analysis. All wear values were determined by calculating head penetration between the follow-up radiograph and the 1-year radiograph to remove creep, the majority of which has been shown to occur during the first year. Separate linear regressions, representing the wear rates, were computed for the early period from 1 year to 5.5 years and the late period from 5.5 years to 9 years follow-up. The Zar test was used to determine the significance of the difference between these two linear regressions. We present the completed analysis of 165 hips. When the early and late data points were combined into one data set, the second-order regression indicated an inflection point at 6.3 years with a slightly positive inflection. There were 402 film comparisons in the early time period, and the slope and confidence interval of the regression line was 4.9μm/yr (95% CI of −28μm/yr to 38μm/yr). There were 188 film comparisons in the late period, and slope of the regression line for the late period was 10.8 μm/yr (95% CI of −58μm/yr to 80μm/yr). The Zar test showed no significant difference between the two slopes (Figure 1, p=0.886). No significant increase in femoral head penetration was found for the late period after 5 years compared to the early period before 5 years follow-up in either analysis. Additionally, no significant late increase in wear was seen within individuals. While we continue to enroll patients, at this time we do not observe the increase in wear seen in the RSA study after 5 years.
Of 960 first-revision total hip replacements (THR) because of deep infection identified in the Swedish Hip Arthroplasty Registry, 16.9% were treated with a permanent implant extraction, while a staged or direct reconstruction revision protocol were employed in 56.2% and 26.9% respectively. The majority of the interventions were performed more than one year after index THR, and the dominating pathogen was coagulase negative staphylococci (CNS). We found a significant shift in types of bacteria over the years (Chi-square test, p smaller than 0.001): an increase in the CNS group and a decrease in Gram-negative aerobes. Patients treated with a permanent resection were generally older (p<
0.001), had more often a previous ipsilateral hip fracture (p<
0.001), and had more frequently Gram-negative infections (p=0.02). No systematic differences in patient characteristics or pathogens were detected between one-stage or two-stage procedures, of which the latter had a median re-implantation time of 2 (range: 0.2–62) months. Of 798 (one- or two-stage) revisions, 60 (7.5%) were revised again due to recurrent infection, with no difference between the two methods, and implying a 10-year survival of 90%; 95% confidence interval (CI95%) 88.2–93.0. Previous surgery for soft-tissue problems (RR 3.2 (CI95% 1.3–7.2)) predicted a worse outcome for one-stage procedures. The prognosis of two-staged revisions improved with increasing re-implantation interval (RR 0.8 (CI95% 0.7–1.0)) per month, and a 6 month interval carried the lowest risk of repeat revision due to infection; RR 0.1 (CI95% 0.0–0.9). Staged revisions in female patients (RR 2.3, (CI95% 0.9–5.7)) and with Staphylococcus aureus infections (RR 2.3 (CI95% 0.9–5.5)) predicted a worse outcome. Ten-year survival with repeat revision for aseptic loosening as end-point was 89% (95%CI 85.7–92.0), but decreased to 79% when all reasons for revision were taken into account (95%CI 75.0–82.3) mainly because of revision for peri-prosthetic fractures. The results suggest that direct and staged revision protocols can have a good prognosis on a national level, but efforts must be made to counteract periprosthetic fractures and the high incidence of permanent implant extraction in elderly patients.
Highly cross-linked polyethylene liners in total hip replacement (THR) have allowed the use of larger diameter femoral heads. Larger heads allow for increased range of motion, decreased implant impingement, and protection against dislocation. The purpose of this study is to report the clinical and radiographic outcomes of patients with large femoral heads with HXLPE at 5 years post-op. A group of 124 patients (132 THRs) who had a primary THR with a 36mm or larger cobalt-chrome femoral head and a Durasul or Longevity liner (Zimmer; Warsaw, IN) were prospectively enrolled in this study. 93 THRs (88 patients) had minimum 5 year follow-up. All patients received a cementless acetabular shell (Trilogy or Inter-op, Zimmer Inc, Warsaw IN) and a highly cross-linked polyethylene liner with an inner diameter of 36 or 38mm. The median radiographic follow-up was 5.6 years (range 5.0–8.0), and patients were assessed clinically by Harris Hip score, UCLA activity score, EQ-5D, and SF-36 functional scores. Femoral head penetration was measured using the Martell Hip Analysis Suite. No osteolysis was seen in the pelvis or proximal femur, and no components failed due to aseptic loosening. Four patients have questionable signs of bone changes around the acetabular shell with future CT scans scheduled to help reach a final determination. The median acetabular shell abduction and anteversion were 44° (30–66°) and 13° (3–33°) respectively. There was no evidence of cup migration, screw breakage, or eccentric wear on the liner. Regarding the femoral component, there were no episodes of loosening, migration, osteolysis, or fracture. There was no significant difference in the median penetration rate from post-op to longest follow-up between the 36mm (24 patients) and 38mm (4 patients) femoral head groups (0.056±0.10mm/yr and 0.060±0.05mm/yr respectively). Therefore, the data were pooled into one group. Using every post-op to follow-up comparison, the linear regression penetration rate of this combined group was 0.003 mm/yr which is within the error detection of the Martell method. The median femoral head penetration rate during the first post-op year measured 0.59±1.04 mm/yr. In contrast, the median steady state wear rate from the 1yr film to the longest follow-up measured -0.009±0.15mm/yr. A linear regression steady state wear rate from the 1 year film to every follow-up of −0.031 mm/yr indicated no correlation between the magnitude of polyethylene wear and time. The mid-term results on this series of patients with THRs with a 36 or 38mm femoral head articulating with highly cross-linked polyethylene showed excellent clinical, radiographic, and wear results. The lack of early signs of osteolysis with the use of these large diameter femoral heads is encouraging. Continued and longer-term follow-up is needed to provide survivorship data.
Highly cross-linked polyethylene (HXLPE) is one of the most widely utilized bearing surfaces for total hip arthroplasty (THA). The first patients to receive XLPE will be 10 years post-op as of December 31, 2008. The purpose of this study is to report the long-term clinical and radiographic outcomes of patients implanted with HXLPE. A group of 247 primary total hip replacements (224 patients) using HXLPE liners (Longevity or Durasul, Zimmer Inc.) with 22, 26, 28, or 32mm femoral heads were implanted between 1999 and 2001. Clinical evaluation measures included the Harris hip, EQ-5D, SF-36 functional scores, and UCLA activity scores. In addition to plain radiograph assessment, the computerized Martell method was used to measure head penetration over time. A matched group of 241 primary total hip replacements (201 patients) with the same head sizes using conventional polyethylene (PE) with a minimum of 7 years follow-up was used as a Martell method control group. The steady state penetration rate was defined as the slope of the linear regression line of the plot of head penetration from the 1 year film to each subsequent film to discount the early bedding-in process. A student’s t-test was used to compare wear rates between head sizes in each group, and a repeated-measures mixed model ANOVA was used to compare the groups for the 28mm head size. There were no osteolytic lesions around the cup or stem, and no revisions were performed for polyethylene wear or liner fracture. Clinical outcome scores were averaged: Harris Hip 88.1±11.97, EQ-5D 74.0±27.0, SF-36 physical activity scores 53.3±8.4, SF-36 mental score 46.9±11.1, and UCLA activity 6.4±2.1. The steady state wear of the conventional polyethylene patients increased with time for both 26 and 28mm head sizes (0.144 and 0.127mm/year, respectively). No significant difference was found between the head sizes coupled with conventional polyethylene (p=0.14). Femoral head penetration in the highly cross-linked polyethylene did not increase over time after the first year. The steady state wear rates of HXLPE liners with 28mm or 32mm femoral heads were not significantly different than a slope of zero (p=0.54 for both head sizes). Clinical follow-up results are typical of a primary THR patient population, and the radiographic results are excellent with no signs of peri-prosthetic osteolysis. Patients with PE show wear rates that are significantly different than zero indicating significant wear of the material. Conversely, patients with HXLPE display no measureable wear at 7–9 years as the wear rates were within the error detection of the Martell method. This long-term clinical and radiographic follow-up study for this new bearing material shows excellent clinical outcomes with very low in vivo wear.
A subgroup of 481 patients in the Western Region of Sweden with complete data on individual CPP (cost per patient) was selected for the health economic analysis.
For RSA, the wear rate for the 28mm femoral head group was 0.05±0.02 while the 36mm femoral head group was 0.03±0.02, p=0.13. For the Martell analysis, the average steady-state wear rate was −0.002 ± 0.01 mm per year and −0.026 ± 0.13 mm per year for 28mm and 32mm head sizes, respectively, p=0.62. There was no correlation between wear and time in situ or femoral head size for any of the clinical studies. In comparing the Martell and Devane programs, the total average wear rates were significantly different, 0.07±0.05 and 0.03±0.06mm/year respectively, p=0.01. However, when the absolute values of the Martell results were used, there was no difference, p=0.22.
In a previous report from a randomised study we reported excellent fixation and less proximal periprosthetic bone mineral loss around the Epoch design at 2 years follow-up when compared with a solid stem of similar design. We now present the 7 years follow-up. Forty consecutive patients (20 men, 10 women, mean age 57, 41–74) with non-inflammatory osteoarthritis were randomised to receive either a cementless porous-coated composite stem with reduced stiffness (Epoch) or a cementless stiff stem with a porous coating (Anatomic). Patients were followed for 7 years with repeated evaluations using radiostereometry, DXA, conventional radiography and Harris Hip Score (HHS). At 7 years 1 stem had been revised (Anatomic) due to late infection. Subsidence and stem rotations were close to zero without any difference between the two groups (p>
0,12). Median wear rates were lower than expected (0.4mm up to 7 years) for both stem designs. At 2 years loss bone mineral density was less in Gruen regions 1, 2, 6 and 7 for the Epoch stems (p<
0.04), but this difference tended to disappear with time. At 7 years only the calcar region (Gruen region 7) had significantly denser bone in the Epoch group (p<
0.001). The HHS scores did not differ (median 98, 51–100). No stem was radiographically loose. The Epoch stem achieved excellent fixation. Wear rates were low despite use of conventionally gamma-sterilised polyethylene. This low modulus stem had positive effects on early proximal bone remodeling, but this effect decreased with time.
Starting in the 1970s, long-term survivorship of total hip and knee arthroplasty has been under investigation for the Scandinavian population with the aid of implants registries. In the United States, no national arthroplasty registry currently exists. Nationwide inpatient discharge databases in the United States have proven useful when comparing the revision burden in the United States and Scandinavia. For this study, we compared the implant survivorship in the Medicare population with contemporaneous registry-based data from well-established and validated Scandinavian arthroplasty registries. The 5% systematic sample of Medicare claims from 1997 to 2004 were examined for primary and revision THA and TKA claims. The Medicare beneficiary ID was used to follow patients longitudinally between primary and revision surgery. De-identified data from the Norwegian and Swedish national hip and knee registry were also obtained for the same time period. During the 8-year study period, 30,583 and 62,878 elective primary total hip or knee replacements, respectively, were extracted from the Medicare data. In the same time period, 41,823 and 15,927 primary total hips or knees replacements were identified from the Norwegian registry. 82,037 primary total hips were identified from the Swedish registry. Survivorship was assessed by the Kaplan-Meier method, and Cox regression was used to evaluate the effect of patient attributes and cross-country comparisons. The K-M estimate showed that 8 years post-primary surgery, 93.6% of THA and 96.2% of TKA remained revision-free among the elderly Medicare population. By comparison, among Norwegians aged 65 and above, 96.0% of THA and 93.6% of TKA remained revision-free. In the US, men had a significantly higher risk of knee revision than women, but no significant gender difference among hip revision. In Norway, men had a significantly higher risk of hip revision, but no differences in knee revisions. In Sweden, men had a significantly higher risk of hip revision (5.4% vs. 3.3%). Older patients had a reduced risk of revision as compared with younger patients, in both the US and in Norway. The survival of THA is significantly better in Norway than in the US with a hazard ratio of 1.64 (p<
0.05). On the other hand, TKA had a better survival experience in the US than in Norway, with a hazard ratio of 0.55 (p<
0.05). This is the first study to evaluate the utility of Medicare as a source of THA and TKA survivorship data and to compare prosthesis outcomes in Medicare with those from Scandinavian arthroplasty registries. Unlike the Norwegian and Swedish registry data, the reasons for revision (e.g., femoral loosening) are not captured and thus greatly limited the value of the Medicare data as a tool to understand the need for revision, thereby helping to improve implant longevity and to reduce the associated cost and burden to the patient and care provider.
The purpose of this study was to compare the 2D and 3D linear and volume wear readings of the three most commonly used methods for measuring polyethylene wear: the Livermore, Devane and Martell techniques. Inter-observer variation of measurements using the techniques of Devane and of Martell on conventional radiographs was also performed. The radiographs of 80 patients (mean age 60+/−10 yrs) who had a Harris-Galante I total hip arthroplasty were measured. Nine different reviewers for the Devane technique readings including Dr Devane and eight reviewers for the Martell technique readings including Dr Martell made blinded independent wear observations for each radiograph set. One reviewer measured the 20 annual linear wear rate for all radiograph sets using the 2D Livermore technique. Inter-observer variation as a function of patient, reviewer, and total variation was statistically assessed using variance component analysis. Mean wear measured using the Livermore technique was the same as with the Devane and Martell method, but with a greater variation. Comparison of the Devane and Martell method for patient STD, reviewer STD, error STD (multiple reviews of same radiographs), total STD (randomly picked reviewer), mostly show a mean 50% lower STD with the Devane technique. Correlation (correlation coefficient of two randomly selected reviewers) is significantly better with the Devane technique.
So far 15 patients, (6 male and 9 females) with a median age of 55 years (range 42–62) have been evaluated in group 1 and 14 (9 male and 5 females) with a median age of 55 years (range 45–70) in group 2. The penetration of the femoral heads has so far been measured postoperatively (all hips supine), after 3 month (17 hips supine and standing) and after 6 month (11 hips supine and standing) using radiostereometry.
1-year follow-up on approximately 50% of the patients will be presented at the meeting.