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A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation

ABSTRACT: Background:Patient-specific cutting blocks in total knee arthroplasty have been promoted to improve mechanical alignment, reduce alignment outliers and improve patient outcomes. The aim of this study was to compare the efficacy of patient-specific instrumentation (PSI) and conventional instrumentation (CI) in achieving neutral alignment and accurate component positioning in total knee arthroplasty. Methods:We conducted a double-blinded randomized controlled trial in which patients were randomly assigned to treatment with either PSI or CI. Results:Fifty-four patients were included in the study. No relevant improvement in coronal alignment was found between the PSI and CI groups with post-hoc power of 0.91. Tibial slope was found to be more accurately reproduced to the preoperative target of 3° with PSI than with CI (3.8°± 3.1° v. 7.7°± 3.6°, respectively, p < 0.001). There were no differences found in patient-reported outcome measures, surgical time or length of hospital stay. Conclusion:Given the added cost of the PSI technique, its use is difficult to justify given the small improvement in only a single alignment parameter. Clinical trial registration:Clinicaltrials.gov, no. NCT03416946

SUBMITTER: Turgeon TR

PROVIDER: S-EPMC6877387 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation

Turgeon Thomas R. TR Cameron Brett B Burnell Colin D. CD Hedden David R. DR Bohm Eric R. ER

Canadian journal of surgery. Journal canadien de chirurgie 20191201 6

<h4>Background</h4>Patient-specific cutting blocks in total knee arthroplasty have been promoted to improve mechanical alignment, reduce alignment outliers and improve patient outcomes. The aim of this study was to compare the efficacy of patient-specific instrumentation (PSI) and conventional instrumentation (CI) in achieving neutral alignment and accurate component positioning in total knee arthroplasty.<h4>Methods</h4>We conducted a double-blinded randomized controlled trial in which patients ...[more]

PMID: 31782643

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Project description:BackgroundOptimal postoperative pain management is important to ensure patient comfort and early mobilization.MethodsIn this double-blind, placebo- and active-controlled, randomized clinical trial, we evaluated postoperative pain following knee replacement in patients receiving placebo, etoricoxib (90 or 120 mg), or ibuprofen 1800 mg daily for 7 days. Patients ≥18 years of age who had pain at rest ≥5 (0-10 Numerical Rating Scale [NRS]) after unilateral total knee replacement were randomly assigned to placebo (N = 98), etoricoxib 90 mg (N = 224), etoricoxib 120 mg (N = 230), or ibuprofen 1800 mg (N = 224) postoperatively. Co-primary endpoints included Average Pain Intensity Difference at Rest over Days 1-3 (0- to 10-point NRS) and Average Total Daily Dose of Morphine over Days 1-3. Pain upon movement was evaluated using Average Pain Intensity Difference upon Knee Flexion (0- to 10-point NRS). The primary objective was to demonstrate analgesic superiority for the etoricoxib doses vs. placebo; the secondary objective was to demonstrate that the analgesic effect of the etoricoxib doses was non-inferior to ibuprofen. Adverse experiences (AEs) including opioid-related AEs were evaluated.ResultsThe least squares (LS) mean (95% CI) differences from placebo for Pain Intensity Difference at Rest over Days 1-3 were -0.54 (-0.95, -0.14); -0.49 (-0.89, -0.08); and -0.45 (-0.85, -0.04) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.05 for etoricoxib vs. placebo). Differences in LS Geometric Mean Ratio morphine use over Days 1-3 from placebo were 0.66 (0.54, 0.82); 0.69 (0.56, 0.85); and 0.66 (0.53, 0.81) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively (p < 0.001 for etoricoxib vs. placebo). Differences in LS Mean Pain Intensity upon Knee Flexion were -0.37 (-0.85, 0.11); -0.46 (-0.94, 0.01); and -0.42 (-0.90, 0.06) for etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively. Opioid-related AEs occurred in 41.8%, 34.7%, 36.5%, and 36.3% of patients on placebo, etoricoxib 90 mg, etoricoxib 120 mg, and ibuprofen, respectively.ConclusionsPostoperative use of etoricoxib 90 and 120 mg in patients undergoing total knee replacement is both superior to placebo and non-inferior to ibuprofen in reducing pain at rest and also reduces opioid (morphine) consumption.Clinical trial registrationNCT00820027.

Project description:BackgroundTotal knee arthroplasty using patient-specific instrumentation (TKA-PSI), which are disposable cutting block guides generated to fit each patient's 3-dimensional knee anatomy, has been developed to treat patients with end-stage osteoarthritis of the knee. Surrogate markers such as radiographic malalignment have been well investigated, however, patient-important outcomes are not well examined to elucidate the efficacy of TKA-PSI. The aim of this review is to determine if TKA-PSI improves patient-reported outcome measures (PROM), surgery time, blood loss, transfusion and complications (e.g. surgical site infection, deep venous thrombosis, and revision TKA).MethodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and ongoing clinical trials. For PROMs, surgery time, blood loss, and transfusion rate, we included randomized controlled trials (RCT) comparing TKA-PSI and standard TKA to treat osteoarthritis of the knee. For complications, we also included non-randomized comparative studies (non-RCT).ResultsThis review includes 38 studies, 24 of which were RCT and 14 of which were non-RCT. These included a total of 3487 patients. The predominant population in the included studies highly reflected the general population, with 62% being female, aged over 60 and having end-stage osteoarthritis of the knee. TKA-PSI did not improve PROMs as compared to standard TKA for less than 1-year (mean difference 0.48, 95% confidence interval (CI) -1.92-0.97 in the Oxford knee score, mean 3-month follow-up) and for 1-year or more (mean difference 0.25, 95%CI - 4.39-4.89 in the WOMAC score, mean 29-month follow-up). TKA-PSI did not reduce surgery time (mean difference - 3.09 min, 95%CI -6.73-0.55). TKA-PSI decreased blood loss with a small effect size corresponding to a 0.4 g/dl hemoglobin decrease (95%CI 0.18-0.88), but did not decrease transfusion rate (risk difference - 0.04, 95%CI -0.09-0.01). TKA-PSI did not reduce complication rates (risk difference 0.00, 95%CI - 0.01-0.01 in the composite outcome).ConclusionsTKA-PSI does not improve patient-reported outcome measures, surgery time, and complication rates as compared to standard TKA. TKA-PSI decreases blood loss with a small effect, which is not enough to reduce transfusion rate.

Project description:ObjectiveTo present a clear and comprehensive summary of the published data on unicompartmental knee replacement (UKA) or total knee replacement (TKA), comparing domains of outcome that have been shown to be important to patients and clinicians to allow informed decision making.DesignSystematic review using data from randomised controlled trials, nationwide databases or joint registries, and large cohort studies.Data sourcesMedline, Embase, Cochrane Controlled Register of Trials (CENTRAL), and Clinical Trials.gov, searched between 1 January 1997 and 31 December 2018.Eligibility criteria for selecting studiesStudies published in the past 20 years, comparing outcomes of primary UKA with TKA in adult patients. Studies were excluded if they involved fewer than 50 participants, or if translation into English was not available.Results60 eligible studies were separated into three methodological groups: seven publications from six randomised controlled trials, 17 national joint registries and national database studies, and 36 cohort studies. Results for each domain of outcome varied depending on the level of data, and findings were not always significant. Analysis of the three groups of studies showed significantly shorter hospital stays after UKA than after TKA (-1.20 days (95% confidence interval -1.67 to -0.73), -1.43 (-1.53 to -1.33), and -1.73 (-2.30 to -1.16), respectively). There was no significant difference in pain, based on patient reported outcome measures (PROMs), but significantly better functional PROM scores for UKA than for TKA in both non-trial groups (mean difference -0.58 (-0.88 to -0.27) and -0.32 (-0.48 to -0.15), respectively). Regarding major complications, trials and cohort studies had non-significant results, but mortality after TKA was significantly higher in registry and large database studies (risk ratio 0.27 (0.16 to 0.45)), as were venous thromboembolic events (0.39 (0.27 to 0.57)) and major cardiac events (0.22 (0.06 to 0.86)). Early reoperation for any reason was higher after TKA than after UKA, but revision rates at five years remained higher for UKA in all three study groups (risk ratio 5.95 (1.29 to 27.59), 2.50 (1.77 to 3.54), and 3.13 (1.89 to 5.17), respectively).ConclusionsTKA and UKA are both viable options for the treatment of isolated unicompartmental osteoarthritis. By directly comparing the two treatments, this study demonstrates better results for UKA in several outcome domains. However, the risk of revision surgery was lower for TKA. This information should be available to patients as part of the shared decision making process in choosing treatment options.Systematic review registrationPROSPERO number CRD42018089972.

Project description:BACKGROUND:The purpose of this study was to compare restoration of mechanical limb alignment and three-dimensional component-positioning between conventional and patient-specific instrumentation in total knee arthroplasty. METHODS:Radiographic data of patients undergoing mobile-bearing total knee arthroplasty (n = 1257), using either conventional (n = 442) or patient-specific instrumentation (n = 812), were analyzed. To evaluate accuracy of axis restoration and 3D-component-positioning between conventional and patient-specific instrumentation, absolute deviations from the targeted neutral mechanical limb alignment and planned implant positions were determined. Measurements were performed on standardized coronal long-leg and sagittal knee radiographs. CT-scans were evaluated for accuracy of axial femoral implant rotation. Outliers were defined as deviations from the targeted neutral mechanical axis of > ±?3° or from the intraoperative component-positioning goals of > ±?2°. Deviations greater than ±?5° from set targets were considered to be severe outliers. RESULTS:Deviations from a neutral mechanical axis (conventional instrumentation: 2.3°± 1.7° vs. patient-specific instrumentation: 1.7°± 1.2°; p < 0.001) and numbers of outliers (conventional instrumentation: 25.8% vs. patient-specific instrumentation: 10.1%; p < 0.001) were significantly lower in the patient-specific instrumentation group. Significantly lower mean deviations and less outliers were detected regarding 3D-component-positioning in the patient-specific instrumentation compared to the conventional instrumentation group (all p < 0.05). CONCLUSIONS:Patient-specific instrumentation prevented from severe limb malalignment and component-positioning outliers (> ±?5° deviation). Use of patient-specific instrumentation proved to be superior to conventional instrumentation in achieving more accurate limb alignment and 3D-component positioning, particularly regarding femoral component rotation. Furthermore, the use of patient-specific instrumentation successfully prevented severe (>?5° deviation) outliers.

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A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation

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A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation

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