Unicompartmental knee arthroplasty: the Italian version of the Forgotten Joint Score-12 is valid and reliable to assess prosthesis awareness.

PURPOSE: Unicompartmental Knee Arthroplasty (UKA) recorded an increased incidence of around 30% per year in the United States. Patient's experience and satisfaction after surgery were traditionally assessed by pre, and post-surgical scores and Patient-Reported Outcome Measures (PROMs) scales. Traditional scales as Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Oxford Knee Score (OKS) reported high ceiling effect. Patients treated by UKA usually perform well; therefore, it is necessary to have a PROMs' scale with a low ceiling effect as the Forgotten Joint Score-12 (FJS-12). PROMs have to be validated in the local language to be used. This study aims to perform a psychometric validation of the Italian version of FJS-12 for UKA for the first time. METHODS: Between January 2019 and October 2019, 44 patients were included. Each patient completed both the FJS-12 Italian version and the WOMAC Italian version in preoperative follow-up, after 2-week and 1-month, 3-month, and 6-month postoperative follow-up. Cronbach's α, intraclass correlation coefficient (ICC), standard error of measurement (SEM), and minimal detectable change (MDC) were calculated to evaluate the reliability. The Pearson coefficient was used to assess validity. The Effect Size (ES) was used to test the responsiveness. RESULTS: A range of Cronbach's α between 0.90 and 0.95 indicated good internal consistency for the FJS-12. The test-retest reliability was acceptable (i.e., the ICC was higher than 0.7) at each follow-up. The Pearson correlation coefficient between the FJS-12 and WOMAC was - 0.11 (n.s.) at preoperative follow-up, r = 0.47 (P = 0.001) at 1 month, r = 0.57 (P < 0.001) at 3 months, and r = 0.57 (P < 0.001) at 6 months. Therefore, except for the preoperative period, the validity of the FJS-12 score was assessed. CONCLUSION: The FJS-12 represents a valid and reliable tool with a low ceiling effect to assess the outcomes improvement in UKA patients. Therefore, validating and translating this score in different languages could help perform more accurate studies on outcomes after UKA. LEVEL OF EVIDENCE: Level III, diagnostic study.

Unicompartmental Knee Arthroplasty: Minimal Important Difference and Patient Acceptable Symptom State for the Forgotten Joint Score.

Background and Objectives: Unicompartmental knee arthroplasty (UKA) is a valid alternative to total knee arthroplasties (TKAs) in selected cases. After surgery, patients' experience and satisfaction were traditionally evaluated by pre- and postsurgical scores and Patient-Reported Outcome Measures (PROMs). Otherwise, a statistically significant change does not necessarily correlate to a clinically meaningful improvement when measured using PROMs. To evaluate the real effect of a specific treatment and understand the difference between groups in a clinical trial, it is necessary to use a meaningful quantum of change on the score assessed. The minimal clinically important difference (MCID) and the Patient Acceptable Symptom State (PASS) can provide this meaningful change. This paper aimed to calculate the MCID and the PASS of the Forgotten Joint Score (FJS-12) after UKA. Materials and Methods: A total of 40 patients with a mean age 72.5 ± 6.4 years undergoing UKA were assessed preoperatively and six months postsurgery using the FJS-12 and the Oxford Knee Score (OKS). The baseline and 6-month postoperative scores were compared using the Wilcoxon signed ranks test. The correlation was calculated with Spearman's rho. Both distribution-based approaches and anchor approaches were used to estimate MCID for the FJS-12. The 75th percentile and the Receiver operating characteristic (ROC) curve methods were used to calculate the PASS of FJS-12. Results: MCID estimates for normalized FJS-12 for UKA ranged from 5.68 to 19.82. The threshold of the FJS-12 with ROC method was 72.92 (AUC = 0.76). The cut-off value computed with the 75th percentile approach was 92.71. Conclusions: The MCID and PASS represent valid tools to assess the real perception of clinical improvement in patients who underwent UKA. The MCID value of FJS-12 was 12.5 for patients who underwent UKA. The value of the PASS for the FJS-12 in patients who underwent UKA was 72.92.

A Historical Analysis of Randomized Controlled Trials in the Management of Pain in Rotator Cuff Tears.

The aim of this analysis was to assess the quality of reporting of randomized controlled trials (RCTs) relating to pain management in rotator cuff (RC) tears. This review evaluated the quality of the studies in the literature regarding this topic through the use of some factors and trends. The online databases used to search all RCTs on the topic of RC surgery were Medline, Scopus, CINAHL, EMBASE, and CENTRAL. This research was completed in September 2020. To assess the quality of reports, the Consolidated Standards of Reporting Trials (CONSORT) and the modified Coleman methodology score (MCMS) were used. From the research, 262 articles emerged. Finally, 79 studies were included in this historical analysis. There were no statistically significant changes in MCMS across trials that included or did not include a CONSORT diagram (p = 0.10). A statistically significant difference in MCMS was discovered between papers produced prior to 2009 and publications produced after 2015 (p = 0.03). There was no association between the number of checklist items for each article and the Coleman score. During the years there has been a significant increase in both quantity and quality of RCTs relating to pain in RC tears.

A Historical Analysis of Randomized Controlled Trials in Rotator Cuff Tears.

Background and objectives: Our research aimed to evaluate the quality of reporting of randomized controlled trials (RCTs) linked to rotator cuff (RC) tears. The present study analyzed factors connected to the quality of the RCTs and trends in the quality of reporting through time. Materials and Methods: The online databases used to search all RCTs on the topic of RC surgery completed until March 2020 were PubMed and Ovid (MEDLINE). The quality of reporting was evaluated using the modified Coleman methodology score (MCMS) and the consolidated standards of reporting trials (CONSORT). Results: The online search found 957 articles. Finally, 183 studies were included in the quantitative synthesis. A total of 97 (53%) of 183 studies had a level of evidence I and 86 (47%) of 183 studies had a level of evidence II, according to the Oxford Center of Evidence Based Medicine (EBM). A statistically significant difference in MCMS between articles written before 2010 and articles written after 2010 was found. Articles written after 2010 had, on average, the highest Coleman score. The average number of CONSORT checklist items for each article across all analyzed RCTs was 21.67. The 37 studies completed up to 2010 averaged a number of checklist items of 19.97 and the studies completed between 2011 and 2019 averaged a number of checklist items of 22.10. A statistically significant difference in the number of checklist items between articles written before 2010 and articles written after 2010 was found. Articles written after 2010 had on average more checklist items. However, low correlation (0.26) between the number of checklist items for each article and the respective Coleman score was found. On the other hand, articles with the CONSORT diagram had a significantly high Coleman score. Conclusions: An improvement in the quantity and quality of RCTs relating to RC surgery over the analyzed period was found.