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The impact of patient-specific instrumentation on unicompartmental knee arthroplasty: a prospective randomised controlled study.

ABSTRACT: PURPOSE:Patient-specific instrumentation (PSI) has been proposed as a means of improving surgical accuracy and ease of implantation during technically challenging procedures such as unicompartmental knee arthroplasty (UKA). The purpose of this prospective randomised controlled trial was to compare the accuracy of implantation and functional outcome of mobile-bearing medial UKAs implanted with and without PSI by experienced UKA surgeons. METHODS:Mobile-bearing medial UKAs were implanted in 43 patients using either PSI guides or conventional instrumentation. Intra-operative measurements, meniscal bearing size implanted, and post-operative radiographic analyses were performed to assess component positioning. Functional outcome was determined using the Oxford Knee Score (OKS). RESULTS:PSI guides could not be used in three cases due to concerns regarding accuracy and registration onto native anatomy, particularly on the tibial side. In general, similar component alignment and positioning was achieved using the two systems (n.s. for coronal/sagittal alignment and tibial coverage). The PSI group had greater tibial slope (p = 0.029). The control group had a higher number of optimum size meniscal bearing inserted (95 vs 52%; p = 0.001). There were no differences in OKS improvements (n.s). CONCLUSION:Component positioning for the two groups was similar for the femur but less accurate on the tibial side using PSI, often with some unnecessarily deep resections of the tibial plateau. Although PSI was comparable to conventional instrumentation based on OKS improvements at 12 months, we continue to use conventional instrumentation for UKA at our institution until further improvements to the PSI guides can be demonstrated. LEVEL OF EVIDENCE:Therapeutic, Level I.

SUBMITTER: Alvand A

PROVIDER: S-EPMC5966491 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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The impact of patient-specific instrumentation on unicompartmental knee arthroplasty: a prospective randomised controlled study.

Alvand Abtin A Khan Tanvir T Jenkins Cathy C Rees Jonathan L JL Jackson William F WF Dodd Christopher A F CAF Murray David W DW Price Andrew J AJ

Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA 20170822 6

<h4>Purpose</h4>Patient-specific instrumentation (PSI) has been proposed as a means of improving surgical accuracy and ease of implantation during technically challenging procedures such as unicompartmental knee arthroplasty (UKA). The purpose of this prospective randomised controlled trial was to compare the accuracy of implantation and functional outcome of mobile-bearing medial UKAs implanted with and without PSI by experienced UKA surgeons.<h4>Methods</h4>Mobile-bearing medial UKAs were impl ...[more]

PMID: 28831554

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Project description:BackgroundThere remains a paucity of clinical studies assessing how any differences in accuracy of implant positioning between robotic-arm assisted unicompartmental knee arthroplasty (RO UKA) and conventional jig-based unicompartmental knee arthroplasty (CO UKA) translate to patient satisfaction, functional outcomes, and implant survivorship. The objectives of this study are to compare accuracy of implant positioning, limb alignment, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in CO UKA versus RO UKA. Computer navigation will be used to assess intraoperative knee kinematics in all patients undergoing CO UKA.Methods and analysisThis prospective randomised controlled trial will include 140 patients with symptomatic medial compartment knee arthritis undergoing primary UKA. Following informed consent, patients will be randomised to CO UKA (control group) or RO UKA (investigation group) at a ratio of 1:1 using an online random number generator. The primary objective of this study is to compare accuracy of implant positioning in CO UKA versus RO UKA. The secondary objectives are to compare the following outcomes between the two treatment groups: limb alignment, surgical efficiency, postoperative functional rehabilitation, functional outcomes, quality of life, range of motion, resource use, cost effectivness, and complications. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes pertaining to these objectives. Ethical approval was obtained from the London-Bloomsbury Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CO UKA versus RO UKA. The findings of this study will provide an improved understanding of the differences in CO UKA versus RO UKA with respect to accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.Trial registrationClinicalTrials.gov NCT04095637 . Registered on 19 September 2019.

Project description:BACKGROUND:Total 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). METHODS:We 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). RESULTS:This 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). CONCLUSIONS:TKA-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:BackgroundPatient-specific instrumentation (PSI) proponents have suggested the benefits of improved component alignment and reduced outliers. In this randomized controlled trial, we attempted to assess the advantage of using PSI over conventional intermedullary (IM) guides for primary total knee arthroplasty (TKA) with bilateral severe femoral bowing (> 5°). A parallel trial design was used with 1:1 allocation. We hypothesize that PSI would support more accurate alignment of components and the lower-limb axis during TKA with severe femoral bowing in comparison with conventional IM guides.MethodsAmong 336 patients undergoing bilateral TKAs due to knee osteoarthritis, 29 patients with bilateral lateral femoral bowing of more than 5° were included in this study. Every patient was assigned randomly to PSI on one side and to conventional instrumentation lateralization of the entry point of the femoral IM guide was applied on the other with a goal of neutral mechanical alignment. The assessment of coronal alignment was completed by measuring the hip-knee-ankle (HKA) angle on preoperative and postoperative long film standing radiographs. Coronal and sagittal orientations of femoral and tibial components were assessed on weight-bearing radiographs. The rotational alignment of the femoral component was evaluated using computed tomography.ResultsThe postoperative mean ± standard deviation (SD) HKA angle was varus 4.0° (± 2.7°) for conventional technique and varus 4.1° (± 3.1°) for PSI, with no differences between the two groups (p = 0.459). The component orientation showed no significant differences except with respect to the sagittal alignment of the femoral component (p = 0.001), with a PSI mean ± SD flexion of 5.8° (± 3.7°) and a conventional method mean ± SD flexion of 3.2° (± 2.5°), due to the intentional 3° flexion incorporated in the sagittal plane to prevent femoral notching in PSI planning. Computed tomography assessment for rotational alignment of the femoral components showed no difference between the two groups concerning the transepicondylar axis (p = 0.485) with a PSI mean ± SD external rotation of 1.5° (± 1.3°) and conventional mean ± SD external rotation of 1.5° (± 1.6°).ConclusionPSI showed no advantage over lateralization of the femoral entry for IM guidance.Level of evidence1 TRIAL REGISTRATION: Registered on US national library of medicine ClinicalTrials.gov ( NCT02993016 ) on December 12th 2016.

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.

Project description:IntroductionMalalignment and resulting complications are major challenges in total knee arthroplasty (TKA) which patient-specific instrumentation (PSI) is proposed to alleviate. Previous PSI meta-analyses of TKA outcomes typically do not differentiate between PSI systems and assess relatively few outcomes, so the value of their findings is limited. VISIONAIRE™ cutting guides (Smith + Nephew Inc., Memphis, TN, USA) is a PSI system based on preoperative magnetic resonance and X-ray imaging. A systematic literature review (SLR) and meta-analysis, focussed specifically on VISIONAIRE, were conducted to assess TKA accuracy, intraoperative outcomes, and postoperative outcomes, compared with conventional instrumentation (CI).Materials and methodsThe SLR was performed using PubMed, Embase, and Google Scholar databases to identify relevant studies published until March 2022. Depending on statistical heterogeneity, meta-analyses were performed for outcome measures with fixed effect (I2 < 50%) or random-effects models (I2 ≥ 50%). Dichotomous outcomes were reported as odds ratios and continuous outcomes were reported as mean differences. Descriptive analyses were performed for outcomes not amenable to meta-analysis.ResultsOutcomes for VISIONAIRE versus CI were reported in 25 studies. Compared with CI, VISIONAIRE reduced odds of mechanical outliers by 40% (p < 0.0001), with no statistically significant differences in odds of overall coronal, sagittal, or rotational plane component outliers. VISIONAIRE improved surgical efficiency (operating room, turnover, and tourniquet times reduced by 7.3% (p = 0.02), 42% (p = 0.022), and 15.9% (p = 0.01), respectively), lowering the odds of blood transfusion by 53% (p = 0.01) and shortening patients' hospital stays (11.1% reduction; p < 0.0001). There were no significant differences between groups in incidence of postoperative complications and (descriptively analyzed) return-to-function outcomes.ConclusionOptions for PSI in TKA differ substantially, and it is important to assess the outcomes of individual systems. The current findings suggest that VISIONAIRE guides can lead to improved alignment accuracy and surgical efficiency compared with CI, without compromising postoperative safety and return-to-function outcomes.

Dataset Information

The impact of patient-specific instrumentation on unicompartmental knee arthroplasty: a prospective randomised controlled study.

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The impact of patient-specific instrumentation on unicompartmental knee arthroplasty: a prospective randomised controlled study.

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