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Manufacturing, oxidation, mechanical properties and clinical performance of highly cross-linked polyethylene in total hip arthroplasty.
Singh, G, Klassen, R, Howard, J, Naudie, D, Teeter, M, Lanting, B
Hip international : the journal of clinical and experimental research on hip pathology and therapy. 2018;(6):573-583
Abstract
Ultra-high molecular weight polyethylene (UHMWPE) continues to be the gold standard bearing surface in total hip arthroplasty (THA) for nearly 5 decades. Highly cross-linked UHMWPE (HXLPE) was adapted for routine use in the early 2000s to reduce the revision rates related to wear, osteolysis, and aseptic loosening resulting from conventional UHMWPE wear. Since its inception, consistent evidence showing reduced wear rates and osteolysis supports the use of HXLPE in THA. High quality studies demonstrating the advantage in long term survivorship of HXLPE over conventional UHMWPE are emerging. Though retrieval studies have demonstrated evidence of in vivo oxidation and fatigue related damage at the rim of the first generation HXLPE liners, clinical significance of this remains to be seen. Second-generation sequentially annealed and vitamin E containing HXLPE liners demonstrate improved mechanical properties, resistance to oxidation, and equivalent wear rates in comparison to their first-generation counterparts, but long term success remains to be seen.
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Creep and Wear in Vitamin E-Infused Highly Cross-Linked Polyethylene Cups for Total Hip Arthroplasty: A Prospective Randomized Controlled Trial.
Rochcongar, G, Buia, G, Bourroux, E, Dunet, J, Chapus, V, Hulet, C
The Journal of bone and joint surgery. American volume. 2018;(2):107-114
Abstract
BACKGROUND Aseptic loosening, the most common indication for revision surgery in total hip arthroplasty, can result from osteolysis caused by polyethylene (PE) wear particles. PE wear is increased by age-related oxidation of PE and free radicals emerging during irradiation cross-linking. Diffusion of vitamin E into PE stabilizes free radicals to maintain the biomechanical properties of PE. The purpose of this study was to determine whether vitamin E-infused highly cross-linked PE cups could reduce wear rates. METHODS We performed a prospective randomized controlled trial, in which 62 patients were allocated to 2 groups: a study group that received a vitamin E-infused highly cross-linked PE (HXLPE/VitE) cup and a control group that received an ultra-high molecular weight PE (UHMWPE) cup. Using radiostereometric analysis, we measured the penetration of the femoral head into the cup 7 days after surgery (baseline) and then again at 6 months and at 1, 2, and 3 years later. RESULTS Baseline variables did not differ significantly between the groups. At 1, 2, and 3 years after surgery, the HXLPE/VitE cup showed significantly less cumulative penetration (creep and wear) than the UHMWPE cup (p = 0.004, p < 0.0001, and p < 0.0001, respectively). The cumulative penetration after 3 years was 0.200 mm for the HXLPE/VitE cup versus 0.317 mm for the UHMWPE cup (p < 0.0001). From 1 to 3 years after surgery, after creep had stabilized and further penetration was mainly due to wear, the mean penetration increased only 0.04 mm in the HXLPE/VitE cup and 0.116 mm in the UHMWPE cup. CONCLUSIONS Our results confirm that wear rates over the first 3 years following surgery were lower in HXLPE/VitE cups than in UHMWPE cups. This suggests that HXLPE/VitE cups may prevent osteolysis, implant loosening, and eventually revision surgery. Long-term follow-up data continue to be collected to confirm these findings. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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Evaluation of in vivo wear of vitamin E-diffused highly crosslinked polyethylene at five years: a multicentre radiostereometric analysis study.
Galea, VP, Connelly, JW, Shareghi, B, Kärrholm, J, Sköldenberg, O, Salemyr, M, Laursen, MB, Muratoglu, O, Bragdon, C, Malchau, H
The bone & joint journal. 2018;(12):1592-1599
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AIMS: The primary aim of this study was to compare the wear properties of vitamin E-diffused, highly crosslinked polyethylene (VEPE) and one formulation of moderately crosslinked and mechanically annealed ultra-high molecular weight polyethylene (ModXLPE) in patients five years after primary total hip arthroplasty (THA). The secondary aim was to assess the clinical results of patients treated with VEPE by evaluating patient-reported outcome measures (PROMs), radiological evidence of fixation, and the incidence of mechanical failure. PATIENTS AND METHODS A total of 208 patients (221 THAs) from four international centres were recruited into a prospective study involving radiostereometric analysis (RSA) and the assessment of clinical outcomes. A total of 193 hips (87%) were reviewed at the five-year follow-up. Of these, 136 (70%) received VEPE (vs ModXLPE) liners and 68 (35%) received ceramic (vs metal) femoral heads. PROMs and radiographs were collected preoperatively and at one, two, and five years postoperatively. In addition, RSA images were collected to measure PE wear postoperatively and at one, two, and five years after surgery. RESULTS We observed similar bedding in one year postoperatively and wear two years postoperatively between the two types of liner. However, there was significantly more penetration of the femoral head in the ModXLPE cohort compared with the VEPE cohort five years postoperatively (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 (β = 0.21, p = 0.013). There was no association between increased wear and the development of radiolucency (p = 0.866) or PROMs. No patient had evidence of osteolysis. CONCLUSION Five years postoperatively, patients with VEPE (vs ModXLPE) and ceramic (vs metal) femoral heads had decreased wear. The rates of wear for both liners were very low and have not led to any osteolysis or implant failure due to aseptic loosening.
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Clinical outcome and physical activity measured with StepWatch 3™ Activity Monitor after minimally invasive total hip arthroplasty.
Höll, S, Blum, A, Gosheger, G, Dieckmann, R, Winter, C, Rosenbaum, D
Journal of orthopaedic surgery and research. 2018;(1):148
Abstract
BACKGROUND Subjective data and physical examinations of patients after total hip arthroplasty are used to assess the outcome. But regarding the physical activity, no objective data can be delivered by existing scores. The level of activity can be measured objectively by counting gait cycles. The aim of this study was to measure activity levels of patients before and after total hip arthroplasty (THA). METHODS Forty-six patients were included in this prospective study. Western Ontario and McMaster Universities Arthritis Index (WOMAC), Harris Hip Score (HHS), and physical activity level based on the number of steps per day were assessed 1 week before surgery, 6 weeks postoperatively, and 3 months postoperatively. To assess the general constitution of the patients, the American Society of Anesthesiologists (ASA) score and BMI were determined. The physical activity level was measured by StepWatch 3™ Activity Monitor (SAM; Orthocare Innovations, Seattle, WA, USA). The number of GCs per day was assessed. Spearman's rank correlation coefficients were used to identify an association between age, body mass index (BMI), and American Society of Anesthesiologists classification with the number of gait cycles and to detect correlation between GCs and HHS and GCs and WOMAC. RESULTS From preoperatively to 6 weeks postoperatively, the number of gait cycles did not alter significantly. Three months postoperatively, the number of GC/d and GC/h improved significantly. HHS and WOMAC improved significantly from before surgery to 6 weeks and to 3 months follow-up. The number of gait cycles per day did not correlate with the HHS and the WOMAC score at any point of measurement. Age, BMI, and ASA classification did not influence the results. CONCLUSION By using a StepWatch 3™ Activity Monitor objective data about physical activity before and after THA can be measured reliable. Subjective and objective data in the postoperative period show different results. Physical activity seems to take longer to reach significantly improved values. By counting gait cycles, surgeons do have an additional tool to measure success after THA.
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No Clinically Important Difference in Pain Scores After THA Between Periarticular Analgesic Injection and Placebo: A Randomized Trial.
Hirasawa, N, Kurosaka, K, Nishino, M, Nakayama, T, Matsubara, M, Tsukada, S
Clinical orthopaedics and related research. 2018;(9):1837-1845
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BACKGROUND Periarticular analgesic injection (PAI) is being used more commonly for pain relief after orthopaedic surgeries. However, there is conflicting evidence regarding the effectiveness of PAI for post-THA pain relief. QUESTIONS/PURPOSES In a double-blind, randomized, controlled trial among patients undergoing same-day bilateral THA, with each patient serving as his or her own control, we asked: (1) Did the pain score as measured on a 100-mm VAS differ between the hips that received PAI versus placebo? (2) Were there differences in complications between the treatment and control hips in these patients? METHODS Over a 1-year period at one center, 45 patients underwent same-day bilateral THA; three were excluded for prespecified reasons, and two declined participation in this randomized, controlled trial, leaving 40 patients (80 THAs) in the study. Patients randomly received PAI in one hip and placebo in the contralateral hip; patients, surgeons, and nurses were blinded in terms of which hip received the PAI and which hip received a placebo saline injection. The PAI solution included ropivacaine, morphine hydrochloride hydrate, methylprednisolone, ketoprofen, and epinephrine. The primary outcome was the VAS for pain at rest 24 hours after THA, measured using a 100-mm horizontal VAS. The VAS score was compared between two groups and assessed to reach the reported threshold values for the minimum clinically important difference (MCID) of 20 mm for the postoperative VAS score. No patients were lost to followup, and there were no missing data for the primary outcome. Complications that occurred during the trial were recorded prospectively with emphasis on infection, wound complications, nerve palsy and allergic reactions to the injections. RESULTS There were no clinically important differences between hips treated with the PAI and those treated with the placebo injection at any point. The hips that received PAI had less pain than those receiving placebo 24 hours after THA (16 ± 17 mm versus 22 ± 20 mm; mean difference, 6 mm; 95% confidence interval [CI], 2-9 mm; p = 0.006), but this effect size was below the MCID of 20 mm and thus is unlikely to be clinically important. The hips that received PAI also had better VAS scores in the recovery room (38 ± 29 mm versus 52 ± 33 mm; mean difference 14 mm; 95% CI, 5-23 mm; p = 0.004) and 3 hours after THA than placebo controls (28 ± 22 mm versus 37 ± 24 mm; mean difference 9 mm; 95% CI, 2-16 mm; p = 0.010). Neither of these differences exceeded the MCID and likewise were unlikely to be clinically important. No complications, including surgical site infections, were observed in either group. CONCLUSIONS Periarticular analgesic injection for pain control after THA did not result in a clinically important reduction in pain at any point examined. Given the expense associated with this PAI mixture and the lack of effectiveness outside this timeframe, we cannot recommend its use. Other mixtures or concentrations of drugs may be helpful in short-stay admissions for THA, but this will require further research. LEVEL OF EVIDENCE Level I, therapeutic study.
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Outcomes of Revision Joint Arthroplasty Due to Metal Allergy and Hypersensitivity: A Systematic Review.
Jauregui, JJ, Desai, SJ, Hodges, V, Hariharan, A, Newman, JM, Adib, F, Maheshwari, AV
Surgical technology international. 2018;:332-336
Abstract
Lower extremity total joint arthroplasty (TJA) is one of the most successful orthopaedic procedures. However, it is estimated that as many as 10% to 20% of TJAs could fail due to various well-known causes. Furthermore, metal allergy-related complications have recently gained attention as one of the potential causes of failure when the common reasons have been excluded. Reported symptoms from metal allergy can include chronic eczema, joint effusions, joint pain, and limited range of motion. Few studies have explored the outcomes of patients undergoing revisions due to allergic complications. The aim of our study is to quantitatively evaluate the outcomes of revision joint arthroplasty due to metal allergy and hypersensitivity.
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Pregabalin and Dexmedetomidine Combined for Pain After Total Knee Arthroplasty or Total Hip Arthroplasty Performed Under Spinal Anesthesia.
Lee, C, Lee, J, Lee, G, Lee, H, Koh, E, Hwang, J
Orthopedics. 2018;(6):365-370
Abstract
Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. This study evaluated the effect of the 2 drugs combined on pain in patients undergoing total knee or hip arthroplasty. A total of 124 patients undergoing total knee or hip arthroplasty under spinal anesthesia were randomly assigned to either group C (n=31, placebo), group P (n=33, pregabalin), group PD (n=29, pregabalin and dexmedetomidine), or group D (n=31, dexmedetomidine). One hour before spinal anesthesia, patients received 150 mg of pregabalin or placebo orally, and a bolus dose of 0.5 µg/ kg of intravenous dexmedetomidine was given over 10 minutes before induction of spinal anesthesia. This was followed by a continuous infusion of 0.5 µg/kg/h or the same calculated volume of normal saline until completion of the surgery. Clinically relevant pain for 24 hours postoperatively, including time to first analgesic request, visual analog scale score, ketorolac dose, and volume of patient-controlled analgesia consumed, was recorded. Group C had significantly longer time to first analgesic request, higher visual analog scale scores at rest and on movement, higher ketorolac dose, and higher volume of patient-controlled analgesia for the first 24 hours postoperatively compared with the other groups. Although group PD and group D had less clinically relevant pain than group P, group PD and group D were not significantly different. Dexmedetomidine was more effective than pregabalin for clinically relevant pain. Pregabalin and dexmedetomidine combined had no synergic effect compared with dexmedetomidine alone. [Orthopedics. 2018; 41(6):365-370.].
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Five-year follow-up of a prospective randomised trial comparing ceramic-on-metal and metal-on-metal bearing surfaces in total hip arthroplasty.
Schouten, R, Malone, AA, Frampton, CM, Tiffen, C, Hooper, G
The bone & joint journal. 2017;(10):1298-1303
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AIMS: The primary aim of this independent prospective randomised trial was to compare serum metal ion levels for ceramic-on-metal (CoM) and metal-on-metal (MoM) bearing surfaces in total hip arthroplasty (THA). Our one-year results demonstrated elevation in metal ion levels above baseline with no significant difference between the CoM and MoM groups. This paper reviews the five-year data. PATIENTS AND METHODS The implants used in each patient differed only in respect to the type of femoral head (ceramic or metal). At five-year follow-up of the 83 enrolled patients, data from 67 (36 CoM, 31 MoM) was available for comparison. RESULTS The mean serum cobalt (Co) and chromium (Cr) ion levels remained above baseline in both groups (CoM: Co 1.16 μg/l (0.41 to 14.67), Cr 1.05 μg/l (0.16 to 12.58); MoM: Co 2.93 μg/l (0.35 to 30.29), Cr 1.85 μg/l (0.36 to 17.00)) but the increase was significantly less in the CoM cohort (Co difference p = 0.001, Cr difference p = 0.002). These medium-term results, coupled with lower revision rates from national joint registries, suggest that the performance of CoM THA may be superior to that of MoM. CONCLUSION While both bearing combinations have since been withdrawn these results provide useful information for planning clinical surveillance of CoM THAs and warrants continued monitoring. Cite this article: Bone Joint J 2017;99-B:1298-1303.
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Comparative effectiveness of venous thromboembolism prophylaxis options for the patient undergoing total hip and knee replacement: a network meta-analysis.
Kapoor, A, Ellis, A, Shaffer, N, Gurwitz, J, Chandramohan, A, Saulino, J, Ishak, A, Okubanjo, T, Michota, F, Hylek, E, et al
Journal of thrombosis and haemostasis : JTH. 2017;(2):284-294
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UNLABELLED Essentials Despite trial data, guidelines have not endorsed direct oral Xa inhibitors above other options. We provide profiles of venous thromboembolism and hemorrhage risk for 12 options. Direct oral Xa inhibitors had a favorable profile compared with low-molecular-weight heparin. Other options did not have favorable profiles compared with low-molecular-weight heparin. SUMMARY Background There are numerous trials and several meta-analyses comparing venous thromboembolism (VTE) prophylaxis options after total hip and knee replacement (THR and TKR). None have included simultaneous comparison of new with older options. Objective To measure simultaneously the relative risk of VTE and hemorrhage for 12 prophylaxis options. Methods We abstracted VTE and hemorrhage information from randomized controlled trials published between January 1990 and June 2016 comparing 12 prophylaxis options. We then constructed networks to compute the relative risk for each option, relative to once-daily dosing with low-molecular-weight heparin (LMWH) Low. Results Main: Relative to LMWH Low, direct oral Xa inhibitors had the lowest risk of total deep vein thrombosis (DVT)-asymptomatic and symptomatic- (odds ratio [OR], 0.45; 95% confidence interval [CI], 0.35-0.57), translating to 53-139 fewer DVTs per 1000 patients. Vitamin K antagonists (VKAs) titrated to International Normalized Ratio [INR] 2-3 predicted 56% more DVT events (OR, 1.56; 95% CI, 1.14-2.14). Aspirin performed similarly (OR, 0.80; 95% CI, 0.34-1.86), although small numbers prohibit firm conclusions. Direct oral Xa inhibitors did not lead to significantly more bleeding (OR, 1.21; 95% CI, 0.79-1.90). Secondary: Relative to LMWH Low, direct oral Xa inhibitors prevented 4-fold more symptomatic DVTs (OR, 0.25; 95% CI, 0.13-0.47). Conclusions Relative to LMWH Low, direct oral Xa inhibitors had a more favorable profile of VTE and hemorrhage risk, whereas VKAs had a less favorable profile. The profile of other agents was not more or less favorable. Clinicians should consider these profiles when selecting prophylaxis options.
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Thromboembolic and major bleeding events in relation to perioperative bridging of vitamin K antagonists in 649 fast-track total hip and knee arthroplasties.
Jørgensen, CC, Kehlet, H, ,
Acta orthopaedica. 2017;(1):55-61
Abstract
Background - The benefit of preoperative bridging in surgical patients with continuous anticoagulant therapy is debatable, and drawing of meaningful conclusions may have been limited by mixed procedures with different thromboembolic and bleeding risks in most published studies. Patients and methods - This was an observational cohort treatment study in consecutive primary unilateral total hip and knee arthroplasty patients between January 2010 and November 2013 in 8 Danish fast-track departments. Data were collected prospectively on preoperative comorbidity and anticoagulants in patients with preoperative vitamin K antagonist (VKA) treatment. We performed 30-day follow-up on in-hospital complications and re-admissions through the Danish National Patient Registry and patient records. Results - Of 13,375 procedures, 649 (4.7%) were in VKA patients with a mean age of 73 (SD 9) years and a median length of stay of 3 days (IQR: 2-4). Preoperative bridging was used in 430 (67%), while 215 (33%) were paused. Of 4 arterial thromboembolic events (ATEs) (0.6%), 2 were in paused patients and 2 were in bridged patients (p = 0.6). Of 3 venous thromboembolic events (VTEs) (0.5%), 2 were in paused patients and 1 was in a bridged patient (p = 0.3). Of 8 major bleedings (MBs) (1.2%), 1 was in a paused patient and 7 were in bridged patients (p = 0.3), 5 of whom received therapeutic bridging. Similar results were found in a propensity-matched cohort. Interpretation - In contrast to recent studies in mixed surgical procedures, no statistically significant differences in ATE, VTE, or MB were found between preoperative bridging and pausation of VKA patients. However, the higher number of thromboembolic events in paused patients and the higher number of major bleedings in bridged patients warrant more extensive investigation.