scholarly journals Core Outcome Measurement Instruments for Clinical Trials of Total Knee Arthroplasty: A Systematic Review

2020 ◽  
Vol 9 (8) ◽  
pp. 2439
Author(s):  
Vivien Reynaud ◽  
Anargyros Verdilos ◽  
Bruno Pereira ◽  
Stéphane Boisgard ◽  
Frédéric Costes ◽  
...  

(1) Background: We have updated knowledge of the psychometric qualities of patient-reported outcome measures and, for the first time, systematically reviewed and compared the psychometric qualities of physical tests for patients with knee osteoarthritis who are undergoing total knee arthroplasty. This work was conducted to facilitate the choice of the most appropriate instruments to use in studies and clinical practice. (2) Methods: A search of medical databases up to December 2019 identified the studies and thus the instruments used. The quality of the measurement properties was assessed by the Bot et al. criteria. (3) Results: We identified 20 studies involving 25 instruments. Half of the instruments were questionnaires (n = 13). Among the condition-specific instruments, the Oxford knee score, Knee injury and Osteoarthritis Outcomes Score, and the Western Ontario and McMaster Universities Osteoarthritis index had the highest overall scores. Concerning generic tools, the Medical Outcomes Study Short-Form 36 (SF-36) or SF-12 obtained the highest overall score. For patient-specific tools, the Hospital Anxiety and Depression Scale ranked the highest. Some physical tests seemed robust in psychometric properties: 6-min Walk Test, five times Sit-To-Stand test, Timed Up and Go test strength testing of knee flexor/extensor by isometric or isokinetic dynamometer and Pressure Pain Threshold. (4) Conclusion: To make stronger recommendations, key areas such as reproducibility, responsiveness to clinical change, and minimal important change still need more rigorous evaluations. Some promising physical tests (e.g., actimetry) lack validation and require rigorous studies to be used as a core set of outcomes in future studies.

2021 ◽  
Vol 10 (3) ◽  
pp. 203-217
Author(s):  
Yiou Wang ◽  
Meihua Yin ◽  
Shibai Zhu ◽  
Xi Chen ◽  
Hongru Zhou ◽  
...  

Patient-reported outcome measures (PROMs) are being used increasingly in total knee arthroplasty (TKA). We conducted a systematic review aimed at identifying psychometrically sound PROMs by appraising their measurement properties. Studies concerning the development and/or evaluation of the measurement properties of PROMs used in a TKA population were systematically retrieved via PubMed, Web of Science, Embase, and Scopus. Ratings for methodological quality and measurement properties were conducted according to updated COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Of the 155 articles on 34 instruments included, nine PROMs met the minimum requirements for psychometric validation and can be recommended to use as measures of TKA outcome: Oxford Knee Score (OKS); OKS–Activity and Participation Questionnaire (OKS-APQ); 12-item short form Knee Injury and Osteoarthritis Outcome (KOOS-12); KOOS Physical function Short form (KOOS-PS); Western Ontario and McMaster Universities Arthritis Index-Total Knee Replacement function short form (WOMAC-TKR); Lower Extremity Functional Scale (LEFS); Forgotten Joint Score (FJS); Patient’s Knee Implant Performance (PKIP); and University of California Los Angeles (UCLA) activity score. The pain and function subscales in WOMAC, as well as the pain, function, and quality of life subscales in KOOS, were validated psychometrically as standalone subscales instead of as whole instruments. However, none of the included PROMs have been validated for all measurement properties. Thus, further studies are still warranted to evaluate those PROMs. Use of the other 25 scales and subscales should be tempered until further studies validate their measurement properties. Cite this article: Bone Joint Res 2021;10(3):203–217.


Author(s):  
Antonio Klasan ◽  
Mei Lin Tay ◽  
Chris Frampton ◽  
Simon William Young

Abstract Purpose Surgeons with higher medial unicompartmental knee arthroplasty (UKA) usage have lower UKA revision rates. However, an increase in UKA usage may cause a decrease of total knee arthroplasty (TKA) usage. The purpose of this study was to investigate the influence of UKA usage on revision rates and patient-reported outcomes (PROMs) of UKA, TKA, and combined UKA + TKA results. Methods Using the New Zealand Registry Database, surgeons were divided into six groups based on their medial UKA usage: < 1%, 1–5%, 5–10%, 10–20%, 20–30% and > 30%. A comparison of UKA, TKA and UKA + TKA revision rates and PROMs using the Oxford Knee Score (OKS) was performed. Results A total of 91,895 knee arthroplasties were identified, of which 8,271 were UKA (9.0%). Surgeons with higher UKA usage had lower UKA revision rates, but higher TKA revision rates. The lowest TKA and combined UKA + TKA revision rates were observed for surgeons performing 1–5% UKA, compared to the highest TKA and UKA + TKA revision rates which were seen for surgeons using > 30% UKA (p < 0.001 TKA; p < 0.001 UKA + TKA). No clinically important differences in UKA + TKA OKS scores were seen between UKA usage groups at 6 months, 5 years, or 10 years. Conclusion Surgeons with higher medial UKA usage have lower UKA revision rates; however, this comes at the cost of a higher combined UKA + TKA revision rate that is proportionate to the UKA usage. There was no difference in TKA + UKA OKS scores between UKA usage groups. A small increase in TKA revision rate was observed for high-volume UKA users (> 30%), when compared to other UKA usage clusters. A significant decrease in UKA revision rate observed in high-volume UKA surgeons offsets the slight increase in TKA revision rate, suggesting that UKA should be performed by specialist UKA surgeons. Level of evidence III, Retrospective therapeutic study.


Author(s):  
Aline Miranda Ferreira ◽  
Rodrigo Salim ◽  
Fabricio Fogagnolo ◽  
Luciano Fonseca Lemos de Oliveira ◽  
Marcelo Riberto ◽  
...  

AbstractQuestionnaires and physical tests are tools to determine the ability of an individual to perform tasks of the daily living. In our institution, a standardized knee performance evaluation including patient-reported outcome measures (PROMs) and physical performance tests has been applied to all patients undergoing total knee arthroplasty (TKA). Our goal was to identify which preoperative tools influence the outcomes of a TKA and if physical performance tests can be of value if used along with PROMs in predicting functional outcomes. Classification and regression tree was used to analyze which preoperative factors influence function after TKA. Western Ontario and McMaster Universities Arthritis Index (WOMAC) function (WOMAC-F), 6-minute walk test (6MWT), and timed up and go (TUG) test at the 12th postoperative month were the dependent variables. Age, body mass index, preoperative WOMAC function and pain score, muscle strength, 6MWT, and TUG test score were used as preoperative predictors of dependent variables. TUG ≤19.3 seconds and age <62 years were preoperative predictors of better scores in the WOMAC-F (5.5). Strength of extensor muscles of the nonoperated knee ≥99.43 N·m/kg and 6MWT> 328 m were preoperative predictors of a better postoperative 6MWT (499 m). TUG <12.3 seconds and 6MWT ≥421 m were preoperative predictors of better postoperative TUG (7.3 seconds). Preoperative performance in physical tests had an influence on postoperative outcome scores than PROMs after TKA. Less age, good muscular strength, greater capacity of walking, and smaller TUG times were associated with better outcomes.


2018 ◽  
Vol 33 (9) ◽  
pp. 2843-2850 ◽  
Author(s):  
Joshua G. Twiggs ◽  
Edgar A. Wakelin ◽  
Justin P. Roe ◽  
David M. Dickison ◽  
Brett A. Fritsch ◽  
...  

2017 ◽  
Vol 31 (08) ◽  
pp. 754-760 ◽  
Author(s):  
Ryan Degen ◽  
Jacob Matz ◽  
Matthew Teeter ◽  
Brent Lanting ◽  
James Howard ◽  
...  

AbstractTotal knee arthroplasty (TKA) is an effective, durable treatment for knee osteoarthritis. However, a subset of patients experiences incomplete pain relief and ongoing dysfunction. Posterior condylar offset (PCO) has previously been shown to be associated with postoperative range of motion (ROM) following TKA; however, an association with patient-reported outcome measures (PROMs) has not been established. The purpose of this study was to evaluate the association between PCO and postoperative ROM and PROMs. A retrospective review of 970 posterior-stabilized single design TKAs was performed. Preoperative and postoperative radiographs were analyzed to measure the change in PCO and anteroposterior (AP) femoral dimension. Clinical outcome measures, including Short Form-12 physical and mental component summaries, Western Ontario and McMaster Universities Arthritis Index, and Knee Society Score were reviewed to determine if these were influenced by changes in PCO and AP dimension. PCO was increased by more than 3 mm in 15.1%, maintained (within 3 mm) in 59.6%, and decreased by more than 3 mm in 25.3% of patients. Comparing between these groups, there were no significant differences in postoperative ROM or PROM. AP dimension increased in 24.4%, maintained in 47.8%, and decreased in 27.8%. Similarly, there were no significant differences in ROM or PROM between these groups. Spearman's correlation analyses failed to identify an association between PCO and ROM or PROMs. In conclusion, increasing or decreasing PCO or AP femoral dimension with this PS TKA design did not significantly affect postoperative ROM or PROM. Similarly, maintenance of PCO within one implant size with this system compared with optimal sizing had no deleterious effect on TKA outcomes.


2019 ◽  
Vol 33 (05) ◽  
pp. 513-524 ◽  
Author(s):  
Corey Scholes ◽  
Milad Ebrahimi ◽  
Nalan Ektas ◽  
John Ireland

AbstractThere is a lack of clinical outcomes reported for the rotating bearing knee (RBK) total knee arthroplasty (TKA), which is a second-generation rotating platform knee, with purported benefits over earlier versions. The purpose of the study was to report the complications, short-term (minimum 1 year) patient-reported outcomes and long-term (up to 15 years) procedure survival in a consecutive series of patients receiving a rotating platform TKA (RBK) from an independent clinic. A retrospective analysis of a single-surgeon, private/public practice, with prospectively collected data in a subset of patients were performed. A total of 1,130 procedures (primary, revision from unicompartmental knee arthroplasty (UKA) to TKA) were crossmatched with manufacturer records. Clinical outcomes (complications, reoperations) were summarized and linked to patient-reported outcome measures (Eq. 5D, KSS-function, Oxford knee score [OKS]). OKS results were classified using minimally clinical important difference (MCID) and patient acceptable symptom state (PASS). PROMs were summarized and regression models used to determine relationships between patient factors and outcomes in this cohort. Cumulative percent revision was reported by the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and compared between the senior author and national data using Kaplan–Meier survival analysis. We report a complication rate of 19.7% with the majority (> 60%) being thromboembolic events and complaints of stiffness. Significant improvements were observed in general health, knee pain, and function with > 89% exceeding the MCID for the OKS and > 65% exceeding the PASS for the OKS at an average follow-up of 3.2 years. We report a cumulative revision rate of 4.3% at 5 years and 4.8% at 14 years, with significantly lower revision rates in females and patients aged 55 to 64 years compared with AOANJRR data for fixed bearing designs. The RBK rotating platform TKA provides good functional outcomes, with relatively low revision and complications rates at up to 14 years follow-up. This design in conjunction with a gap balancing technique may be advantageous in certain patient subgroups.


Arthroplasty ◽  
2021 ◽  
Vol 3 (1) ◽  
Author(s):  
Amit Pansky ◽  
Yaron Bar-Ziv ◽  
Eran Tamir ◽  
Aharon Finestone ◽  
Gabriel Agar ◽  
...  

Abstract Background This prospective study aimed to assess the reliability and validity of the Hebrew version of the forgotten joint score-12 in patients undergoing total knee arthroplasty, because it is going to be used in the Hebrew-speaking populations in Israel. Methods The English version of forgotten joint score-12 was translated into Hebrew version by using the standard procedures and in collaboration with its authors. The consecutive patients who had undergone total knee arthroplasty in a single hospital were asked to fill out the Hebrew version of forgotten joint score-12, Oxford knee score, Short Form 12, and visual analog scale. A random subgroup of 60 patients were then asked to fill out a second Hebrew version of forgotten joint score-12 at a minimum of 2-week interval. The reliability was assessed in terms of internal consistency, test-retest reliability and split-half reliability. The validity was measured in terms of the outcomes as mentioned above. Results A total of 102 patients participated in the study. The Hebrew version of forgotten joint score-12 showed high reliability. The internal consistency was excellent (Cronbachs’ α = 0.943) and test-retest reliability was high (Intraclass correlation = 0.97). The forgotten joint scores were correlated with the Oxford knee score, Short Form 12, and visual analog scale (r = 0.86, r = 0.72, and r=-0.8, respectively), indicating a high validity. Conclusions The Hebrew version of forgotten joint score-12 has excellent reliability, excellent test-retest reliability and good validity. It can be safely used for assessing outcomes of TKA.


2017 ◽  
Vol 31 (07) ◽  
pp. 649-653 ◽  
Author(s):  
Jerry Chen ◽  
Hwei Chong ◽  
Hee Pang ◽  
Darren Tay ◽  
Shi-Lu Chia ◽  
...  

AbstractThis study aims to investigate the functional outcomes of pinless navigation (BrainLAB VectorVision Knee 2.5 navigation system; Munich, Germany) as an intraoperative alignment guide in total knee arthroplasty (TKA). A prospective, 24-month follow-up study of 100 patients who were scheduled and randomized into two groups, the pinless navigation and conventional surgery, was conducted. All TKAs were performed with the surgical aim of achieving neutral coronal alignment with the 180-degree mechanical axis. The outcomes measured in this study were Oxford Knee Score (OKS), Knee Society Score (KSS), Short Form-36 (SF-36), and range of motion (ROM). At 24-month postoperatively, four and two patients were lost to follow-up from the pinless navigation group and conventional group, respectively. There were no significant differences in absolute scores of the OKS, KSS, and ROM, as well as changes from preoperative baseline, between pinless navigation and conventional groups at both 6 and 24 months postoperatively. Pinless navigation results in comparable functional outcomes as conventional TKA at 6 and 24 months postoperatively.


2019 ◽  
Vol 33 (05) ◽  
pp. 452-458 ◽  
Author(s):  
Adam I. Edelstein ◽  
Surabhi Bhatt ◽  
Josh Wright-Chisem ◽  
Ryan Sullivan ◽  
Matt Beal ◽  
...  

AbstractUp to 20% of total knee arthroplasty (TKA) patients report dissatisfaction with their outcome, especially with weight-bearing in flexion (WBiF) activities. Sagittal plane instability may contribute to dissatisfaction following TKA. We assessed the impact of implant design on TKA sagittal plane stability and clinical satisfaction. We randomized patients to receive one of two TKA implant designs: medial-stabilized (MS) or posterior-stabilized (PS). Sagittal stability was assessed using a KT-1000 arthrometer. Patient-reported outcome measures, including a custom bank of questions targeting patient satisfaction (0–100%) with WBiF activities, were administered to patients 2 years following surgery. The final analysis included 50 patients (25 MS, 25 PS). The MS group had greater sagittal plane stability than the PS group at 30-degree flexion (5.6 ± 1.9 vs. 10.2 ± 2.7 mm; p < 0.0001) but not at 90-degree flexion (4.1 ± 2 vs. 5.3 ± 3 mm; p = 0.14). Range of motion was not different (111.3 ± 10.4 vs. 114.7 ± 10.7 degrees; p = 0.31). There were no differences in the PROMIS (Patient-Reported Outcomes Measurement Information System) score, Oxford Knee Score, Knee Society Score, Forgotten Joint Score, or Veterans Rand. The MS group had no difference in satisfaction for WBiF activities versus non-WBiF activities (80.5 ± 18 vs. 88.3% ± 16.4%; p = 0.13), whereas the PS group had significantly worse satisfaction for WBiF versus non-WBiF activities (71.6 ± 24.6 vs. 87.8% ± 16.6%; p = 0.019). An MS prosthetic design was more stable in the sagittal plane in midflexion compared with a PS design. There was no difference in patient-reported outcomes, although custom survey data suggest improved satisfaction with MS design during WBiF activities.


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