Background: Anterior cruciate ligament reconstructions (ACLRs) fail at an alarmingly high rate in young active individuals. The Multicenter Orthopaedic Outcomes Network (MOON) knee group has developed an autograft risk calculator that uses patient characteristics and lifestyle to predict the probability of graft rupture if the surgeon uses a hamstring tendon (HT) or a bone–patellar tendon–bone (BPTB) graft to reconstruct the ligament. If validated, this risk calculator can be used during the shared decision-making process to make optimal ACLR autograft choices and reduce rupture rates. The STABILITY 1 randomized clinical trial offers a large, rigorously collected data set of similar young active patients who received HT autograft with or without lateral extra-articular tenodesis (LET) for ACLR. Purpose/Hypothesis: The purpose was to validate the ACLR graft rupture risk calculator in a large external data set and to investigate the utility of BPTB and LET for ACLR. We hypothesized that the risk calculator would maintain adequate discriminative ability and calibration in the external STABILITY 1 data set when compared with the initial MOON development data set. Study Design: Cohort study (diagnosis); Level of evidence, 1. Methods: The model predictors for the risk calculator include age, sex, body mass index, sport played at the time of injury, Marx Activity Score, preoperative knee laxity, and graft type. The STABILITY 1 trial data set was used for external validation. Discriminative ability, calibration, and diagnostic test validity of the model were assessed. Finally, predictor strength in the initial and validation samples was compared. Results: The model showed acceptable discriminative ability (area under the curve = 0.73), calibration (Brier score = 0.07), and specificity (85.3%) to detect patients who will experience a graft rupture. Age, high-grade preoperative knee laxity, and graft type were significant predictors of graft rupture in young active patients. BPTB and the addition of LET to HT were protective against graft rupture versus HT autograft alone. Conclusion: The MOON risk calculator is a valid predictor of ACLR graft rupture and is appropriate for clinical practice. This study provides evidence supporting the idea that isolated HT autografts should be avoided for young active patients undergoing ACLR. Registration: NCT00463099 (MOON); NCT02018354 (STABILITY 1) ( ClinicalTrials.gov identifiers)
BackgroundThe Knee Injury and Osteoarthritis Outcome Score (KOOS) is well known and commonly used to assess young, active patients with ACL injuries. However, this application of the outcome measure has been called into question. There is currently no evidence supporting the structural validity of the KOOS for this patient population. Structural validity refers to whether a questionnaire meant to provide scores on different subscales behaves as intended in the populations of interest. Structural validity should be assessed for all questionnaire measures with multiple items or subscales.Questions/purposesDoes the KOOS demonstrate adequate structural validity in young, active patients with ACL tears, when evaluated using (1) exploratory and (2) confirmatory factor analyses?MethodsBetween January 2014 and March 2017, 1033 patients were screened for eligibility in the Stability 1 randomized controlled trial from nine centers in Canada and Europe. Patients were eligible if they had an ACL deficient knee, were between 14 and 25 years old, and were thought to be at higher risk of reinjury based on the presence of two or more of the following factors: participation in pivoting sports, presence of a Grade 2 pivot shift or greater, generalized ligamentous laxity (Beighton score of 4 or greater), or genu recurvatum greater than 10°. Based on this criteria, 367 patients were ineligible and another 48 declined to participate. In total, 618 patients were randomized into the trial. Of the trial participants, 98% (605 of 618) of patients had complete baseline KOOS questionnaire data available for this analysis. Based on study inclusion criteria, the baseline KOOS data from the Stability 1 trial represents an appropriate sample to investigate the structural validity of the KOOS, specifically for the young, active ACL deficient population.A cross sectional retrospective secondary data analysis of the Stability 1 baseline KOOS data was completed to assess the structural validity of the KOOS using exploratory and confirmatory factor analyses. Exploratory factor analysis investigates how all questionnaire items group together based on their conceptual similarity in a specific sample. Confirmatory factor analysis is similar but used often in a second stage to test and confirm a proposed structure of the subscales. These methods were used to assess the established five-factor structure of the KOOS (symptoms [seven items], pain [nine items], activities of daily living [17 items], sport and recreation [five items], and quality of life [four items]) in young active patients with ACL tears. Incremental posthoc modifications, such as correlating questionnaire items or moving items to different subscales, were made to the model structure until adequate fit was achieved. Model fit was assessed using chi-square, root mean square error of approximation (RMSEA) and an associated 90% confidence interval, comparative fit index (CFI), Tucker-Lewis index (TLI), as well as standardized root mean square residual (SRMR). Adequate fit was defined...
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