Dataset Information

Effects of patient-specific positioning guides (PSPGs) vs. conventional instrumentation on patient-reported outcome in total knee arthroplasty: secondary analysis of a randomized controlled trial after 5 years.

ABSTRACT:

Background and purpose

The use of patient-specific positioning guides (PSPGs) in total knee arthroplasty (TKA) has been advocated as a means of improving patient outcomes, but the reception of PSPGs has been mixed. The aim of our study was to compare patient-reported outcomes (KOOS, NRS-11, EQ-5D-3L, EQ-VAS) after TKA using PSPG with conventional instrumentation (CI) to determine whether there is a discernible clinical benefit to using PSPGs.

Patients and methods

This multicenter randomized controlled trial (RCT) followed 77 patients who were randomly assigned to 1 of 2 cohorts between September 2011 and January 2014-one receiving TKA with PSPGs (from Materialise NV) and one receiving TKA with CI-with each cohort followed up until 5 years after the operation. The Vanguard Cruciate Retaining Total Knee System and Refobacin Bone Cement R were used in all operations. KOOS was evaluated using confidence intervals, with differences of less than 10 KOOS units between the cohorts interpreted as indicating the absence of a clinically meaningful difference.

Results

No significant differences were found in any of the measured clinical outcomes-KOOS, NRS-11, EQ-5D-3L, EQ-VAS, range of motion, or radiolucent lines scoring-between the cohort operated on using PSPG and the cohort operated on using CI after 5 years of follow-up.

Conclusion

There was no statistically significant effect of PSPGs on patient-reported outcomes or range of motion in TKA.

SUBMITTER: Rivrud SCS

PROVIDER: S-EPMC10370263 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

Effects of patient-specific positioning guides (PSPGs) vs. conventional instrumentation on patient-reported outcome in total knee arthroplasty: secondary analysis of a randomized controlled trial after 5 years.

Rivrud Sean C S SCS Röhrl Stephan M SM Van Leeuwen Justin A M J JAMJ

Acta orthopaedica 20230720

<h4>Background and purpose</h4>The use of patient-specific positioning guides (PSPGs) in total knee arthroplasty (TKA) has been advocated as a means of improving patient outcomes, but the reception of PSPGs has been mixed. The aim of our study was to compare patient-reported outcomes (KOOS, NRS-11, EQ-5D-3L, EQ-VAS) after TKA using PSPG with conventional instrumentation (CI) to determine whether there is a discernible clinical benefit to using PSPGs.<h4>Patients and methods</h4>This multicenter ...[more]

PMID: 37493231

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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.

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:BackgroundThe aim of this study was to compare the efficacy and safety of patient-specific instrumentation (PSI) and conventional instrumentation (CI) for unicompartmental knee arthroplasty. Our hypothesis was that the PSI would be superior to CI in improving implant positioning and clinical function.MethodsWe searched electronic databases (PubMed, Web of Science, Embase, and Cochrane) to identify relevant studies published before July 1, 2023 that met our inclusion criteria. The identified reports at least included one of the following outcome variables: coronal component alignment, sagittal component alignment, number of outliers, hip-knee-ankle angle, postoperative complications, operative time and knee joint functional evaluation. For dichotomous variables, we calculated the risk ratio and its 95% confidence interval (CI). For continuous variables, we calculated the mean difference (MD) and its 95% CI. Heterogeneity of the included studies was assessed using the standard chi-square test. Meta-analyses were performed using RevMan 5.4. software. The meta-analysis was registered with PROSPERO (No. CRD42023454160).ResultsA total of 9 articles were included in the analysis, consisting of 4 randomized controlled trials and 5 cohort studies. The study population comprised 494 patients, with 262 in the PSI group and 232 in the CI group. Our findings demonstrate that the PSI group exhibits superior tibial component coronal alignment compared to the CI group (MD = -0.66, 95% CI: -1.21 to -0.12, P = .02). Conversely, the CI group demonstrates better femoral component coronal alignment than the PSI group (MD = 0.89, 95% CI: 0.17-1.60, P = .01). No significant between 2 groups differences were observed in tibial component sagittal alignment, femoral component sagittal alignment, tibial coronal axis outliers, tibial sagittal axis outliers, femoral coronal axis outliers, femoral sagittal axis outliers, postoperative complications, operative time, hip-knee-ankle angle, and postoperative knee joint function score.ConclusionsOur study findings suggest that the PSI confer an advantage in achieving superior tibial component coronal alignment, whereas the CI associated with better femoral component coronal alignment. However, no significant differences were observed between the groups in terms of other parameters. Future studies with larger sample sizes are needed to validate these findings.

Project description:BackgroundThere is an existing perception that obesity has a negative impact on complications following total knee arthroplasty (TKA). However, data on the impact of obesity levels on patient-reported outcomes (PROMs) is sparse. We investigated the association between different obesity classes with PROMs among patients who underwent TKA.MethodsWe performed retrospective secondary analyses on data extracted from the total joint replacement data repository (Alberta, Canada) managed by the Alberta Bone and Joint Health Institute (ABJHI). Patients had WOMAC and EQ5D scores measured at baseline in addition to 3 and/or 12 months following TKA. Patients were stratified according to the World Health Organization (WHO) classification, into five body mass index (BMI) groups of normal, overweight, BMI class I, BMI class II, and BMI class III. The association between BMI and mean changes in WOMAC subscales (pain, function, and stiffness) and EQ-5D-5L index over the time intervals of baseline to 3 months and 3 to 12 months following TKA was assessed. Linear mixed-effects models were used, and the models were adjusted for age, sex, length of surgery, comorbidities, year of surgery, and geographical zone where the surgery was performed.ResultsMean age was 65.5 years (SD = 8.7). Postoperatively, there was a significant improvement (p < 0.001) in WOMAC subscales of patient-reported pain, function, and stiffness, as well as EQ-5D-5L regardless of BMI group. Although, patients in BMI class II and class III reported significantly improved pain 3 months after TKA compared to those with normal BMI, all BMI groups attained similar level of pain reduction at 12 months after TKA. The greatest improvement in all WOMAC subscales, as well as EQ5D index, occurred between baseline and 3 months (adjusted p < 0.0001).ConclusionThe findings indicate that patients reported improved pain, function, and stiffness across all BMI groups following TKA. Patients with BMI classified as obese reported similar benefits to those with BMI classified as normal weight. These results may help health care providers to discuss expectations regarding the TKA recovery in terms of pain, function, and quality of life improvements with their TKA candidates.

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.

Dataset Information

Effects of patient-specific positioning guides (PSPGs) vs. conventional instrumentation on patient-reported outcome in total knee arthroplasty: secondary analysis of a randomized controlled trial after 5 years.

Background and purpose

Patients and methods

Results

Conclusion

Publications

Effects of patient-specific positioning guides (PSPGs) vs. conventional instrumentation on patient-reported outcome in total knee arthroplasty: secondary analysis of a randomized controlled trial after 5 years.

Similar Datasets

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