Dataset Information

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

ABSTRACT:

Introduction

Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants.

Methods

A review of primary studies included in health technology assessments (HTA) on total (TKA) and unicompartmental knee arthroplasty (UKA) was conducted. MEDLINE, EMBASE, CINAHL, Cochrane Library and Biotechnology & BioEngineering Abstracts were searched from 2005 to 2014, plus journal tables of contents and 32 HTA web sites. Patients were aged 18 and older who underwent primary TKA or UKA assessed in cohort or randomized controlled studies. Summary statistics were used to report study characteristics.

Results

A total of 265 eligible primary studies published between 1986 and 2014 involving 59,217 patients were identified in 10 HTAs (2 low, 7 moderate, 1 high risk of bias). Most evaluated TKA (198, 74.5%). The quality of evidence in primary studies was limited. Most studies were industry-funded (23.8%) or offered no declaration of funding or conflict of interest (44.9%); based on uncontrolled single cohorts (58.5%), enrolled fewer than 100 patients (66.4%), and followed patients for 2 years or less (UKA: single cohort 29.8%, comparative cohort 16.7%, randomized trial 25.0%; TKA: single cohort 25.0%, comparative cohort 31.4%, randomized trial 48.6%). Furthermore, most devices were evaluated in only one study (55.3% TKA implants, 61.1% UKA implants).

Conclusions

Patients, physicians, hospitals and payers rely on poor-quality evidence to support decisions about knee implants. Further research is needed to explore how decisions about the use of devices are currently made, and how the evidence base for device safety and effectiveness can be strengthened.

SUBMITTER: Gagliardi AR

PROVIDER: S-EPMC5047591 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Publications

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

Gagliardi Anna R AR Ducey Ariel A Lehoux Pascale P Ross Sue S Trbovich Patricia P Easty Anthony A Bell Chaim C Takata Julie J Pabinger Christof C Urbach David R DR

PloS one 20161003 10

<h4>Introduction</h4>Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants.<h4>Methods</h4>A review of primary studies ...[more]

PMID: 27695077

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Project description:BackgroundIsolated patellofemoral osteoarthritis (PF-OA) is a common subtype of knee osteoarthritis, leading to a huge economic burden on health care systems. Although previous studies have shown that patellofemoral arthroplasty (PFA) and total knee arthroplasty (TKA) have good clinical effects, it remains largely unclear which treatment is more effective for patients with isolated PF-OA. We aimed to compare postoperative function, complications, revision rates, level of physical activity, and satisfaction rate between the two surgical techniques.MethodsOur study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Search of literature was conducted in MEDLINE, EMBASE, Cochrane Library, and Web of Science until November 2020. The included studies were those that provided direct comparison of postoperative outcomes between PFA and TKA. Data were extracted from eligible studies and combined to calculate the pooled odds ratio (OR) and 95% confidence interval (CI). Sensitivity analysis and subgroup analysis were conducted to evaluate heterogeneity between the two groups.ResultsA total of 7 eligible studies (3 recent randomized controlled trials and 4 nonrandomized controlled trials) were included in this meta-analysis. The pooled results showed that both the PFA group and the TKA group had improved postoperative indicators, suggesting that the two operation modes could improve the knee function and quality of life of patients. Throughout the first 2 years postoperatively, higher activity level, and better functional recovery were observed for PFA compared with TKA in this study; moreover, the differences between the two operation modes were statistically significant (p < 0.05). We found no significant difference in complications, revision rates, and satisfaction rate between the two procedures.ConclusionAlthough there was no observed difference in the complications, revision rates, and satisfaction rate between PFA and TKA, PFA was superior to TKA in terms of knee function and physical activity in the first 2 years postoperatively. Therefore, PFA is a safe, effective, and less invasive treatment for patients with isolated PF-OA. Our findings are consistent with the systematic review of current evidence that PFA may be more suitable for younger patients with high activity needs. Patient selection is, therefore, thought to be of paramount importance. Individualized surgical plan should be designed according to the patient's age, BMI, KOA site, and activity level and combined with the doctor's personal experience.

Project description:OBJECTIVES:To assess cost-effectiveness of enhanced recovery pathways following total hip and knee arthroplasties. Secondary objectives were to report on quality of studies and identify research gaps for future work. DESIGN:Systematic review of cost-utility analyses. DATA SOURCES:Ovid MEDLINE, Embase, the National Health Service Economic Evaluations Database and EconLit, January 2000 to August 2019. ELIGIBILITY CRITERIA:English-language peer-reviewed cost-utility analyses of enhanced recovery pathways, or components of one, compared with usual care, in patients having total hip or knee arthroplasties for osteoarthritis. DATA EXTRACTION AND SYNTHESIS:Data extracted by three reviewers with disagreements resolved by a fourth. Study quality assessed using the Consensus on Health Economic Criteria list, the International Society for Pharmacoeconomics and Outcomes Research and Assessment of the Validation Status of Health-Economic decision models tools; for trial-based studies the Cochrane Collaboration's tool to assess risk of bias. No quantitative synthesis was undertaken. RESULTS:We identified 17 studies: five trial-based and 12 model-based studies. Two analyses evaluated entire enhanced recovery pathways and reported them to be cost-effective compared with usual care. Ten pathway components were more effective and cost-saving compared with usual care, three were cost-effective, and two were not cost-effective. We had concerns around risk of bias for all included studies, particularly regarding the short time horizon of the trials and lack of reporting of model validation. CONCLUSIONS:Consistent results supported enhanced recovery pathways as a whole, prophylactic systemic antibiotics, antibiotic-impregnated cement and conventional ventilation for infection prevention. No other interventions were subject of more than one study. We found ample scope for future cost-effectiveness studies, particularly analyses of entire recovery pathways and comparison of incremental changes within pathways. A key limitation is that standard practices have changed over the period covered by the included studies. PROSPERO REGISTRATION NUMBER:CRD42017059473.

Project description:There is debate in the literature whether rotating hinge knee (RHK) or constrained condylar knee (CCK) prostheses lead to better clinical outcomes and survival rates in patients undergoing revision total knee arthroplasty (RTKA). The purpose of this meta-analysis is to compare the survivorship and clinical outcomes of RHK and CCK prostheses. In this meta-analysis, we reviewed studies that evaluated pain and function scores, range of motion (ROM), complications, and survival rates in patients treated with RHK or CCK with short-term (<5 years) or midterm (5-10 years) follow-up. The survivorship was considered as the time to additional surgical intervention such as removal or revision of the components. A total of 12 studies (one randomized study and 11 non-randomized studies) met the inclusion criteria and were analyzed in detail. The proportion of the knees in which short-term (<5 years) survival rates (RHK, 83/95; CCK, 111/148; odds ratio [OR] 0.52; 95% CI, 0.24-1.11; P = 0.09) and midterm (5-10 years) survival rates (RHK, 104/128; CCK, 196/234; OR 1.05; 95% CI, 0.56-1.97; P = 0.88) were evaluated did not differ significantly between RHK and CCK prostheses. In addition, there were no significant differences in ROM (95% CI: -0.40 to 9.93; P = 0.07) and complication rates (95% CI: 0.66 to 2.49; P = 0.46). In contrast, CCK groups reported significantly better pain score (95% CI: 0.50 to 2.73; P = 0.005) and function score (95% CI: 0.01 to 2.00; P = 0.05) than RHK groups. This meta-analysis revealed that 87.4% of RHK and 75.0% of CCK prostheses survive at short-term (<5 years), while 81.3% of RHK and 83.8% of CCK prostheses survive at midterm (5-10 years). The differences in standardized mean pain and function scores we detected were likely to be imperceptible to patients and almost certainly below the minimum clinically important level, despite a significant difference in both groups. Based on the findings of the current meta-analysis, RHK prostheses continue to be an option in complex RTKA with reasonable midterm survivorship.

Dataset Information

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

Introduction

Methods

Results

Conclusions

Publications

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

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