Results from the Stability Study suggest that adding a lateral extra-articular tenodesis (LET) to a hamstring tendon autograft reduces the rate of anterior cruciate ligament reconstruction (ACLR) failure in high-risk patients. The purpose of this study is to report adverse events over the 2-year follow-up period and compare groups (ACLR alone vs. ACLR + LET). Stability is a randomized clinical trial comparing hamstring tendon ACLR with and without LET. Patients aged 14-25 years with an ACL deficient knee were included. Patients were followed and adverse events documented (type, actions taken, resolution) with visits at 3, 6, 12, and 24 months postoperatively. Adverse events were categorized as none, minor medical, minor surgical, contralateral ACL rupture, or graft rupture. Patient reported outcome measures (PROMs) collected at each visit included the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee Score (IKDC), and ACL Quality of Life Questionnaire (ACL-QOL). In total, 618 patients were randomized (mean age 18.9 years, 302 (49%) male). Forty-five patients (7%) suffered graft rupture; 34 (11%) in the ACLR group compared to 11 (4%) in the ACLR + LET group (RRR = 0.67, 95% CI 0.36 to 0.83, p < 0.001). There were no differences in effusion or infection rates between groups. The ACLR + LET group experienced an increased number of hardware removals (10 vs. 4). Overall, the rate of minor medical events (11%), minor surgical events (7%), and ipsilateral or contralateral ACL tears (10%) were low considering the high-risk patient profile. Increasing severity of adverse events was associated with lower PROMs at 24 months post-operative. Patients in the ACLR + LET group reported greater degree of pain at 3 months only. There were no clinically significant differences in range of motion between groups. The addition of LET to hamstring tendon autograft ACLR in young patients at high risk of re-injury resulted in a statistically significant reduction in graft rupture. While the addition of LET may increase rates of hardware irritation, there was no significant increase in overall rates of minor medical adverse events, minor surgical events, or overall re-operation rates. The concerns regarding complications associated with a LET did not materialize in this study. Level I.

Objective Women are often advised to return to activity (RTA) as early as 6 weeks postpartum, despite undergoing significant physical, physiological and psychological changes. Our objective was to examine existing evidence and clinical practice guidelines to navigate a safe and successful RTA or return to sport (RTS) postpartum. Methods We searched CINAHL, Embase, Medline, PsycINFO and SPORTDiscus and included any secondary studies with recommendations or guidelines for RTA or RTS postpartum. Grey literature and primary sources were excluded. Four reviewers independently screened titles and abstracts, followed by full-text review for eligibility, with conflicts resolved by a third-party reviewer. One reviewer extracted data, which was cross-referenced by another reviewer. Results 5851 studies were screened, and 33 were included in this scoping review. Most studies stated that RTS postpartum can begin once ‘medically safe’, around 6 weeks postpartum, but this term was generally left undefined. In addition, most studies recommended engaging in 150 min of moderate-vigorous physical activity per week after 6 weeks postpartum, but the type of exercise recommended was often non-specific. Conclusion A lack of consistent, evidence-based guidelines exist for RTA or RTS postpartum. Multiple evidence gaps require additional research to inform patient and activity specific guidelines for a safe and successful RTA or RTS postpartum.

Background: The 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/purposes: Does the KOOS demonstrate adequate structural validity in young, active patients with ACL tears, when evaluated using (1) exploratory and (2) confirmatory factor analyses? Methods: Between 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 as a CFI and TLI > 0.9, and RMSEA and SRMR < 0.08. Results: Structural validity of the KOOS was not confirmed when evaluated using (1) exploratory or (2) confirmatory factor analyses. The exploratory factor analysis, where the 42 KOOS items were allowed to group naturally, did not reflect adequate fit for a five-factor model (TLI = 0.828). Similarly, the confirmatory factor analysis used to investigate the KOOS structure as it was originally developed, revealed inadequate fit in our sample (RMSEA = 0.088 [90% CI 0.086 to 0.091]). Our analysis suggested a modified four-factor structure may be more appropriate in young, active ACL deficient patients; however, the final version presented here is not appropriate for clinical use because of the number and nature of post-hoc modifications required to reach adequate fit indices. Conclusion: The established five-factor structure of the KOOS did not hold true in our sample of young, active patients undergoing ACL reconstruction, indicating poor structural validity. Clinical Relevance: We question the utility and interpretability of KOOS subscale scores for young, active patients with ACL tears with the current form of the KOOS. A modified version of the KOOS, adjusted for this patient population, is needed to better reflect and interpret the outcomes and recovery trajectory in this high-functioning group. A separate analysis with a defined a priori development plan would be needed to create a valid alternative.

It is critical to understand the sex-related differences influencing ACL injuries to improve research and care. The Sex and Gender Equity in Research Guidelines provide instructions for incorporating sex and gender differences into health research and emphasise the need to explicitly discuss the associated implications for interpretation of study results and clinical application: https://wwweaseorguk/wp-content/uploads/2016/09/Sagerfor-webpdf.2

Objectives To understand the factors influencing young athletes’ perceptions of quality of life (QOL) following an anterior cruciate ligament (ACL) rupture, prior to reconstructive surgery. Design Qualitative descriptive study using semi-structured interviews and thematic analysis of data. Setting Tertiary sports medicine clinic with patients recruited from the practices of three specialist orthopaedic surgeons. Participants Twenty athletes aged 14–25 provided consent to participate in the study and completed interviews prior to their ACL reconstruction surgery. Participants were eligible to participate if they were scheduled to undergo ACL reconstruction, were 25 years of age or younger, identified as athletes (participated in any level of organised sport), could communicate in English and agreed to be audio recorded. Participants were not eligible if they had experienced a multiligament injury or fracture. Results Young athletes shared common factors that made up their QOL; social connections and support, sport, health, and independence. However, participants’ perceptions of their current QOL were quite variable (13–95/100 on a Visual Analogue Scale). Participants who were able to reframe their injury experience by shifting focus to the positive or unaffected aspects of their lives tended to have more favourable perceptions of their QOL than participants who shifted focus to the losses associated with injury. Conclusions Young athletes who have experienced an ACL injury define their QOL based on social support, sport, health and independence. Individual processes of adaptation and cognitive reframing in response to an ACL injury may exert a greater influence on postinjury QOL than the physical ramifications of the injury itself. Understanding individual perceptions may help target potential interventions or supports to enhance athletes’ adaptation to injury.

Background: The International Knee Documentation Committee Subjective Knee Form (IKDC) is the most highly recommended patient reported outcome measure for assessing patients with anterior cruciate ligament (ACL) injuries and those undergoing ACL reconstruction (ACLR) surgery. The IKDC was developed as a unidimensional instrument for a variety of knee conditions. Structural validity, which determines how an instrument is scored, has not been definitively confirmed for the IKDC in respondents with ACL injuries, and in fact an alternative two-factor/subscale structure has been proposed in this population. The purpose of this study was to determine the most appropriate structure and scoring system for the IKDC in young active patients following ACL injury. Methods: In total, 618 young patients deemed at high risk of graft rupture were randomized into the Stability 1 trial. Of the trial participants, 606 patients (98%) completed a baseline IKDC questionnaire used for this analysis. A cross sectional retrospective secondary data analysis of the Stability 1 baseline IKDC data was completed to assess the structural validity of the IKDC using exploratory and confirmatory factor analyses. Factor analyses were used to test model fit of the intended one-factor structure, a two-factor structure, and alternative four-factor and bifactor structures (i.e., a combination of a unidimensional factor with additional specific factors) of the IKDC, in a dataset of young active ACL patients. Results: The simple one-factor and two-factor structures of the IKDC displayed inadequate fit in our dataset of young ACL patients. A bifactor model provided the best fit. This model contains one general factor that is substantially associated with all items, plus four secondary, more specific content factors (symptoms, activity level, activities of daily living, and sport) with generally weaker associations to subsets of items. Although the single-factor model did not provide unambiguous support to unidimensionality of the IKDC based on fit indices, the bifactor model supports unidimensionality of the IKDC when covariance between items with similar linguistic structure, response options, or content are acknowledged. Conclusions: Overall, findings of a bifactor model with evidence of a reliable general factor well defined by all items lends support to continue interpreting and scoring this instrument as unidimensional. This should be confirmed in other samples. Clinically, based on these findings, the IKDC can be represented by a single score for young active patients with ACL tears. A more nuanced interpretation would also consider secondary factors such as sport and activity level. Trial registration: The Stability 1 trial for which these data were collected was registered on ClinicalTrial.gov (NCT02018354).