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Short-term safety and effectiveness of a second-generation motion-guided total knee system.

ABSTRACT: Background:Modern knee prostheses are designed to more closely replicate normal knee kinematics. The JOURNEY II Bi-Cruciate Stabilized Total Knee System (Smith & Nephew Inc., Memphis, TN) is a second-generation motion-guided knee system that demonstrates axial rotation patterns during flexion, which resemble those of the normal knee. The aim of this study was to assess the short-term safety and effectiveness of this system in standard clinical practice. Methods:A total of 186 subjects (209 primary total knee arthroplasties [TKAs]) were enrolled at 12 U.S. sites. Subjects were operated on between December 2011 and October 2013 and followed for 24 months. Radiographic, clinical, and patient-reported outcome data were collected at 6-, 12-, and 24-month postoperatively. Results:At 24-month follow-up, the average objective Knee Society Score was 96.20 (standard deviation [SD] = 6.63), the average satisfaction score was 35.22 (SD = 6.63), the average expectation score was 10.91 (SD = 3.16), and the average functional activities score was 81.49 (SD = 14.65). On a 0-10 scale, pain level for walking was 0.79 (SD = 1.51) and 1.50 (SD = 1.97) for climbing stairs or inclines. The cumulative incidence of reoperation at 2-year follow-up was 1.48% (95% confidence interval [CI] 0.48%-4.52%). Ten TKAs in 7 patients were treated with closed manipulations for stiffness. Iliotibial band syndrome was reported in 2 TKAs. Two deep infections occurred, 1 requiring reoperation. No dislocations occurred in the study cohort. Conclusions:In short-term follow-up, the JOURNEY II Bi-Cruciate Stabilized Guided Motion Total Knee System appears to be a safe and effective device for TKA.

SUBMITTER: Harris AI

PROVIDER: S-EPMC5994596 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Short-term safety and effectiveness of a second-generation motion-guided total knee system.

Harris Adam I AI Luo Tianyi David TD Lang Jason E JE Kopjar Branko B

Arthroplasty today 20180216 2

<h4>Background</h4>Modern knee prostheses are designed to more closely replicate normal knee kinematics. The JOURNEY II Bi-Cruciate Stabilized Total Knee System (Smith & Nephew Inc., Memphis, TN) is a second-generation motion-guided knee system that demonstrates axial rotation patterns during flexion, which resemble those of the normal knee. The aim of this study was to assess the short-term safety and effectiveness of this system in standard clinical practice.<h4>Methods</h4>A total of 186 subj ...[more]

PMID: 29896561

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Project description:ImportancePrescription opioid use is common among patients with moderate to severe knee osteoarthritis before undergoing total knee replacement (TKR). Preoperative opioid use may be associated with worse clinical and safety outcomes after TKR.ObjectiveTo determine the association of preoperative opioid use among patients 65 years and older with mortality and other complications at 30 days post-TKR.Design, setting, and participantsThis cohort study used claims data from January 1, 2010, to December 31, 2014, from a random sample of US Medicare enrollees 65 years and older who underwent TKR. Based on opioid dispensing in 360 days prior to TKR, patients were classified as continuous (≥1 opioid dispensing in each of the past 12 months) or intermittent (any dispensing of opioids in the past 12 months but not continuous use) opioid users or as opioid-naive patients (no opioids dispensed in the past 12 months). Data analyses were conducted from October 3, 2017, to November 8, 2018.Main outcomes and measuresPrimary outcomes included in-hospital mortality and 30-day post-TKR mortality, hospital readmission, and revision operation. Secondary safety outcomes at 30 days post-TKR included opioid overdose and vertebral and nonvertebral fracture. Multivariable Cox proportional hazards models estimated hazard ratios (HRs) and 95% CIs.ResultsOf 316 593 patients (mean [SD] age, 73.9 [5.8] years; 214 677 [67.8%] women) who underwent TKR, 22 895 (7.2%) were continuous opioid users, 161 511 (51.0%) were intermittent opioid users, and 132 187 (41.7%) were opioid naive. In-hospital mortality occurred in 276 patients (0.09%). At 30 days post-TKR, 828 patients (0.26%) died, 16 786 patients (5.30%) had hospital readmission, and 921 patients (0.29%) had a revision operation. All primary and secondary outcomes occurred more frequently among continuous opioid users compared with opioid-naive patients. Compared with opioid-naive patients and after adjusting for demographic characteristics, combined comorbidity score, number of different prescription medications, and frailty, continuous opioid users had greater risk of revision operations (HR, 1.63; 95% CI, 1.15-2.32), vertebral fractures (HR, 2.37; 95% CI, 1.37-4.09), and opioid overdose (HR, 4.82; 95% CI, 1.36-17.07) at 30 days post-TKR. However, after adjusting covariates, there were no statistically significant differences in in-hospital (HR, 1.18; 95% CI, 0.73-1.90) or 30-day (HR, 1.05; 95% CI, 0.73-1.51) mortality between continuous opioid users and opioid-naive patients.Conclusions and relevanceAfter adjusting for baseline risk profiles, including comorbidities and frailty, continuous opioid users had a higher risk of revision operations, vertebral fractures, and opioid overdose at 30 days post-TKR but not of in-hospital or 30-day mortality, compared with opioid-naive patients. These results highlight the need for better understanding of patient characteristics associated with chronic opioid use to optimize preoperative assessment of overall risk after TKR.

Project description:BackgroundUnicompartmental knee arthroplasty (UKA) is an established treatment option for patients with unicompartmental osteoarthritis (OA). However, strict patient selection is crucial for its success. The proposed advantages include nearly natural knee kinematics, faster rehabilitation and better functional outcomes. Despite the aforementioned facts and it's proven cost-effectiveness, there are still hesitations for the use of UKA as an alternative to total knee arthroplasty (TKA). Key objectives of this study were therefore to assess clinical and patient-reported outcome (PRO) as well as patient's satisfaction after medial UKA in comparison to TKA.MethodsTo assess the outcome after UKA we conducted a prospective multi-center study. 116 patients with unicompartmental OA and indication for UKA were included. Overall 54 females and 62 males with an average age of 62.7 years (±9.8) and an average body mass index (BMI) of 29.2 (± 3.7) were recruited. Clinical results and PRO were assessed using the Knee Society Score (KSS). Follow-ups took place 3 months, 1 and 2 years after surgery including clinical examination, radiographs, assessment of PRO and adverse events. Pain and satisfaction was evaluated using a visual analog scale (VAS, 0 (worst) to 10 (best)). For comparison with TKA a propensity score matched-pair analysis was performed to eliminate confounders. Matching criteria were gender, patient's age, BMI and comorbidities. A total of 116 matched-pairs were analysed.ResultsThere was no revision in the UKA group until 2 years after surgery. Revision rates were higher in the TKA group (0.6%). Preoperative KSS-Scores were higher within the UKA cohort (p < 0.001). After surgical treatment, PROMs displayed a significant improvement (p < 0,001) in both cohorts. Regarding the Knee-Score (Pain, Alignment, ROM) we observed no differences between cohorts after 12 months. The Function-Score demonstrated significantly better results in the UKA cohort (UKA vs. TKA 95 vs 80, p < 0.001). Patient satisfaction was also higher in UKA patients (UKA vs TKA 9.0 vs 8.8, p = 0.019).ConclusionPatients of both cohorts showed high satisfaction after knee arthroplasty. UKA resulted in higher function scores compared to TKA without increased revision rate during short-term follow-up. Therefore, UKA is a good treatment option for unicompartmental OA.Trial registrationClinicaltrials.gov, NCT04598568 . Registered 22 October 2020 - Retrospectively registered.

Project description:OBJECTIVES:To assess the effectiveness and reporting standards of psychological interventions for improving outcomes after total knee replacement (TKR). DESIGN:Medline, Embase, and PsycINFO were searched from inception to up to 9 May 2019 with no language restrictions applied. Randomised controlled trials (RCTs) assessing the effectiveness of psychological interventions for short-term and long-term postoperative pain after TKR were included. Screening, data extraction, and assessment of methodological quality were performed in duplicate by two reviewers. The primary effectiveness outcome was postoperative pain severity and the primary harm outcome was serious adverse events. Secondary outcomes included function, quality of life, and psychological well-being. Reporting standards were assessed using the Template for Intervention Description and Replication (TIDieR) checklist for intervention reporting. RESULTS:12 RCTs were included, with a total of 1299 participants. Psychological interventions comprised music therapy (five studies), guided imagery and music (one study), hypnosis (one study), progressive muscle relaxation with biofeedback (one study), pain coping skills programme (one study), cognitive-behavioural therapy (two studies), and a postoperative management programme (one study). Due to the high heterogeneity of interventions and poor reporting of harms data, it was not possible to make any definitive statements about the overall effectiveness or safety of psychology interventions for pain outcomes after TKR. CONCLUSION:Further evidence about the effectiveness of psychological interventions for improving pain outcomes after TKR is needed. The reporting of harm outcomes and intervention fidelity is currently poor and could be improved. Future work exploring the impact of intervention timing on effectiveness and whether different psychological approaches are needed to address acute postoperative pain and chronic postoperative pain would be of benefit. PROSPERO REGISTRATION NUMBER:CRD42018095100.

Project description:Surgical pain is managed with multi-modal anaesthesia in total hip replacement (THR) and total knee replacement (TKR). It is unclear whether including local anaesthetic infiltration before wound closure provides additional pain control.We performed a systematic review of randomised controlled trials of local anaesthetic infiltration in patients receiving THR or TKR. We searched MEDLINE, Embase and Cochrane CENTRAL to December 2012. Two reviewers screened abstracts, extracted data, and contacted authors for unpublished outcomes and data. Outcomes collected were post-operative pain at rest and during activity after 24 and 48 hours, opioid requirement, mobilisation, hospital stay and complications. When feasible, we estimated pooled treatment effects using random effects meta-analyses.In 13 studies including 909 patients undergoing THR, patients receiving local anaesthetic infiltration experienced a greater reduction in pain at 24 hours at rest by standardised mean difference (SMD) -0.61 (95% CI -1.05, -0.16; p = 0.008) and by SMD -0.43 (95% CI -0.78 -0.09; p = 0.014) at 48 hours during activity.In TKR, diverse multi-modal regimens were reported. In 23 studies including 1439 patients undergoing TKR, local anaesthetic infiltration reduced pain on average by SMD -0.40 (95% CI -0.58, -0.22; p < 0.001) at 24 hours at rest and by SMD -0.27 (95% CI -0.50, -0.05; p = 0.018) at 48 hours during activity, compared with patients receiving no infiltration or placebo. There was evidence of a larger reduction in studies delivering additional local anaesthetic after wound closure. There was no evidence of pain control additional to that provided by femoral nerve block.Patients receiving local anaesthetic infiltration spent on average an estimated 0.83 (95% CI 1.54, 0.12; p = 0.022) and 0.87 (95% CI 1.62, 0.11; p = 0.025) fewer days in hospital after THR and TKR respectively, had reduced opioid consumption, earlier mobilisation, and lower incidence of vomiting.Few studies reported long-term outcomes.Local anaesthetic infiltration is effective in reducing short-term pain and hospital stay in patients receiving THR and TKR. Studies should assess whether local anaesthetic infiltration can prevent long-term pain. Enhanced pain control with additional analgesia through a catheter should be weighed against a possible infection risk.

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Short-term safety and effectiveness of a second-generation motion-guided total knee system.

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Short-term safety and effectiveness of a second-generation motion-guided total knee system.

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