Measurement of success following anterior cruciate ligament reconstruction (ACLR) hinges on the appropriate use of high quality and meaningful outcome measures. We identified and categorized over 100 ...outcome measures for ACLR using the International Classification of Functioning, Disability and Health (ICF) model. The ICF model is a useful framework to facilitate decisions about outcome selection and describe recovery following ACL injury. We outline key considerations when selecting outcome measures during study design (purpose, measurement properties, sample size, global assessment) or evaluating reported outcomes (measurement properties, sample size, magnitude/precision, clinical relevance, applicability), and discuss challenges in outcome measurement following ACLR.
Background:
Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft failure.
Hypothesis:
We ...hypothesized that a single-bundle, hamstring ACLR in combination with a lateral extra-articular tenodesis (LET) would reduce the risk of ACLR failure in young, active individuals.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
This is a multicenter, prospective, randomized clinical trial comparing a single-bundle, hamstring tendon ACLR with or without LET performed using a strip of iliotibial band. Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL). The primary outcome was ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture. Secondary outcome measures included the P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire. Patients were reviewed at 3, 6, 12, and 24 months postoperatively.
Results:
A total of 618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years) were randomized. A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL. There were 18 patients lost to follow-up and 11 who withdrew (~5%). In the ACLR group, 120/298 (40%) patients sustained the primary outcome of clinical failure, compared with 72/291 (25%) in the ACLR+LET group (relative risk reduction RRR, 0.38; 95% CI, 0.21-0.52; P < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; P < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 (P = .003) and KOOS (P = .007), with KOOS pain persisting in favor of the ACLR group to 6 months (P = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale (P = .11).
Conclusion:
The addition of LET to a single-bundle hamstring tendon autograft ACLR in young patients at high risk of failure results in a statistically significant, clinically relevant reduction in graft rupture and persistent rotatory laxity at 2 years after surgery.
Registration:
NCT02018354 (ClinicalTrials.gov identifier)
Background:
The Knee injury and Osteoarthritis Outcome Score–Anterior Cruciate Ligament (KOOS-ACL) is a short form version of the KOOS, developed to target populations of young active patients with ...ACL tears. The KOOS-ACL consists of 2 subscales: Function (8 items) and Sport (4 items). The KOOS-ACL was developed and validated using data from the Stability 1 study from baseline to postoperative 2 years.
Purpose:
To validate the KOOS-ACL in an external sample of patients matching the outcome’s target population.
Study Design:
Cohort study (diagnosis); Level of evidence, 1.
Methods:
The Multicenter Orthopaedic Outcomes Network group cohort of 839 patients aged 14 to 22 years who tore their ACLs while playing sports was used to assess internal consistency reliability, structural validity, convergent validity, responsiveness to change, and floor/ceiling effects of the KOOS-ACL at 4 time points: baseline and postoperative 2, 6, and 10 years. Detection of treatment effects between graft type (hamstring tendon vs bone–patellar tendon–bone) were also compared between the full-length KOOS and KOOS-ACL.
Results:
The KOOS-ACL demonstrated acceptable internal consistency reliability (α = .82-.89), structural validity (Tucker-Lewis index and comparative fit index = 0.98-0.99; standardized root mean square residual and root mean square error of approximation = 0.04-0.07), convergent validity (Spearman correlation with International Knee Documentation Committee subjective knee form = 0.66-0.85; Western Ontario and McMaster Universities Osteoarthritis Index function = 0.84-0.95), and responsiveness to change across time (large effect sizes from baseline to postoperative 2 years; d = 0.94 Function and d = 1.54 Sport). Stable scores and significant ceiling effects were seen from 2 to 10 years. No significant differences in KOOS or KOOS-ACL scores were detected between patients with different graft types.
Conclusion:
The KOOS-ACL shows improved structural validity when compared with the full-length KOOS and adequate psychometric properties in a large external sample of high school and college athletes. This strengthens the argument to use the KOOS-ACL to assess young active patients with ACL tears in clinical research and practice.
ObjectivesTo understand the factors influencing young athletes’ perceptions of quality of life (QOL) following an anterior cruciate ligament (ACL) rupture, prior to reconstructive ...surgery.DesignQualitative descriptive study using semi-structured interviews and thematic analysis of data.SettingTertiary sports medicine clinic with patients recruited from the practices of three specialist orthopaedic surgeons.ParticipantsTwenty 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.ResultsYoung 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.ConclusionsYoung 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
Injury to the anterolateral ligament (ALL) has been reported to contribute to high-grade anterolateral laxity after anterior cruciate ligament (ACL) injury. Failure to address ALL injury ...has been suggested as a cause of persistent rotational laxity after ACL reconstruction. Lateral meniscus posterior root (LMPR) tears have also been shown to cause increased internal rotation of the knee.
Questions/purposes
The purpose of this study was to determine the functional relationship between the ALL and LMPR in the control of internal rotation of the ACL-deficient knee. Specifically: (1) We asked if there was a difference in internal rotation among: the intact knee; the ACL-deficient knee; the ACL/ALL-deficient knee; the ACL/LMPR-deficient knee; and the ACL/ALL/LMPR-deficient knee. (2) We also asked if there was a difference in anterior translation among these conditions.
Methods
Sixteen fresh frozen cadaveric knee specimens (eight men, mean age 79 years) were potted into a hip simulator (femur) and a 6 degree-of-freedom load cell (tibia). Rigid optical trackers were inserted into the proximal femur and distal tibia, allowing for the motion of the tibia with respect to the femur to be tracked during biomechanical tests. A series of points on the femur and tibia were digitized to create bone coordinate systems that were used to calculate internal rotation and anterior translation. Biomechanical testing involved applying a 5-Nm internal rotation moment to the tibia from full extension to 90° of flexion. Anterior translation was performed by applying a 90-N anterior load using a tensiometer. Both tests were performed in 15° increments tested sequentially in the following conditions: (1) intact; and (2) ACL injury (ACL−). The specimens were then randomized to either have the ALL sectioned (3) first (M+/ALL−); or (4) the LMPR sectioned first (M−/ALL+) followed by the other structure (M−/ALL−). A one-way analysis of variance was performed for each sectioning condition at each angle of knee flexion (α = 0.05).
Results
At 0° of flexion there was an effect of tissue sectioning such that internal rotation of the M−/ALL− condition was greater than ACL− by 1.24° (p = 0.03; 95% confidence interval CI, 0.16–2.70) and the intact condition by 2.5° (p = 0.01; 95% CI, 0.69–3.91). In addition, the mean (SD) internal rotations for the M+/ALL− (9.99° 5.39°) and M−/ALL+ (12.05° 5.34°) were greater by 0.87° (p = 0.04; 95% CI, 0.13–3.83) and by 2.15°, respectively, compared with the intact knee. At 45° the internal rotation for the ACL− (19.15° 9.49°), M+/ALL− (23.70° 7.00°), and M−/ALL− (18.80° 8.27°) conditions was different than the intact (12.78° 9.23°) condition by 6.37° (p = 0.02; 95% CI, 1.37–11.41), 8.47° (p < 0.01; 95% CI, 3.94–13.00), and 6.02° (p = 0.01; 95% CI, 1.73–10.31), respectively. At 75° there was a 10.11° difference (p < 0.01; 95% CI, 5.20–15.01) in internal rotation between the intact (13.96° 5.34°) and the M+/ALL− (23.22° 4.46°) conditions. There was also a 4.08° difference (p = 0.01; 95% CI, 1.14–7.01) between the intact and M−/ALL− (18.05° 7.31°) conditions. Internal rotation differences of 6.17° and 5.43° were observed between ACL− (16.28° 6.44°) and M+/ALL− (p < 0.01; 95% CI, 2.45–9.89) as well as between M+/ALL− and M−/ALL− (p = 0.01; 95% CI, −8.17 to −1.63). Throughout the range of flexion, there was no difference in anterior translation with progressive section of the ACL, meniscus, or ALL.
Conclusions
The ALL and LMPR both play a role in aiding the ACL in controlling internal rotation laxity in vitro; however, these effects seem to be dependent on flexion angle. The ALL has a greater role in controlling internal rotation at flexion angles > 30
o
. The LMPR appears to have more of an effect on controlling rotation closer to extension.
Clinical Relevance
Injury to the ALL and/or LMPR may contribute to high-grade anterolateral laxity after ACL injury. The LMPR and the ALL, along with the iliotibial tract, appear to act in concert as secondary stabilizers of anterolateral rotation and could be considered as the “anterolateral corner” of the knee.
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.
Does the KOOS demonstrate adequate structural validity in young, active patients with ACL tears, when evaluated using (1) exploratory and (2) confirmatory factor analyses?
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.
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.
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.
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.
Purpose To determine whether the addition of lateral extra-articular tenodesis (LET) to anterior cruciate ligament (ACL) reconstruction would provide greater control of rotational laxity and improved ...clinical outcomes compared with ACL reconstruction alone. Methods Two independent reviewers searched 9 databases for randomized and nonrandomized clinical studies comparing ACL reconstruction plus LET versus ACL reconstruction alone in a human adult population. All years and 5 languages were included. Animal and cadaveric studies, revision or repair surgical techniques, and studies focused on biomechanical outcomes were excluded. Quality assessment of the included studies was performed with the Cochrane Collaboration tool. Outcomes of interest included the pivot-shift test, KT-1000/-2000 measurements (MEDmetric, San Diego, CA), and International Knee Documentation Committee scores. Results The literature search yielded 3,612 articles. After titles and abstracts were reviewed, 106 articles were selected for full-text review, of which 29 studies met the inclusion criteria (8 randomized and 21 nonrandomized studies). Of the 8 randomized studies, 3 concluded that the results were nonsignificant between treatment groups, 4 were in favor of the extra-articular tenodesis, and 1 was in favor of the ACL reconstruction alone. The Cochrane Collaboration tool showed an unclear to high risk of bias for most articles. A meta-analysis showed a statistically significant difference for the pivot-shift test ( P = .002, I2 = 34%) in favor of ACL reconstruction with LET. No difference was found between the groups for International Knee Documentation Committee scores ( P = .75, I2 = 19%) and KT-1000/-2000 measurements ( P = .84, I2 = 34%). Conclusions Meta-analysis showed a statistically significant reduction in pivot shift in favor of the combined procedure. Studies lacked sufficient internal validity, sample size, methodologic consistency, and standardization of protocols and outcomes. Level of Evidence Level III, systematic review of Level I, II, and III studies.
Diagnostic test study.
To determine the reliability and validity or diagnostic accuracy of two previously described endplate structural defect (EPSD) assessment methods.
Studies of EPSD may further ...the understanding of pathoanatomical mechanisms underlying back pain. However, clinical imaging methods used to document EPSD have not been validated, leaving uncertainty about what the observations represent.
Using an evaluation manual, 418 endplates on CT sagittal slices obtained from 19 embalmed cadavers (9 men and 10 women, aged 62-91 y) were independently assessed by two experienced radiologists and a novice for EPSD using the two methods. The corresponding micro-CT (µCT) from the harvested T7-S1 spines were assessed by another independent rater with excellent intra-rater reliability (Kappa=0.96).
Inter-rater reliability was good for presence (Kappa=0.60-0.69) and fair for specific phenotypes (Kappa=0.43-0.58) of EPSD. Erosion, for which the Brayda-Bruno classification lacked a category, was mainly (82.8%) classified as wavy/irregular, while many notched defects (n=15, 46.9%) and Schmorl's nodes (n=45, 79%) were recorded as focal defects using Feng's classification. When compared to µCT, endplate fractures (n=53) and corner defects (n=28) were routinely missed on CT. Endplates classified as wavy/irregular on CT corresponded to erosion (n=29, 21.2%), jagged defects (n=21, 15.3%), calcification (n=19, 13.9%), and other phenotypes on µCT. Some focal defects on CT represented endplate fractures (n=21, 27.6%) on µCT. Overall, with respect to the presence of an EPSD, there was a sensitivity of 70.9% and specificity of 79.1% using Feng's method, and 79.5% and 57.5% using Brayda-Bruno's. Poor to fair inter-rater reliability (k=0.26-0.47) was observed for defect dimensions.
There was good inter-rater reliability and evidence of criterion validity supporting assessments of EPSD presence using both methods. However, neither method contained all needed EPSD phenotypes for optimal sensitivity, and specific phenotypes were often misclassified.
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. 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. 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. 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.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
To assess the effectiveness of surgical vs conservative interventions on pain and function in patients with subacromial impingement syndrome.
Systematic review and meta-analysis of randomized ...controlled trials.
Clinical setting.
Patients 18 years and older with subacromial impingement syndrome.
Surgical intervention plus postoperative physiotherapy / placebo surgery plus physiotherapy or physiotherapy only.
Pain and function.
11 RCTs (n = 919) were included. The pooled results displayed no statistically or clinically different between surgery plus physiotherapy vs physiotherapy alone on pain levels at 3-, 6-months, 5- and 10 years follow up (moderate quality, 3 RCTs, 300 patients, WMD -0.39, 95% CI: -1.02 to 0.23, p = 0.22; moderate quality, 3 RCTs, 310 patients, WMD -0.36, 95% CI: -1.02 to 0.29, p = 0.27; low quality, 1 RCT, 109 patients, WMD -0.30, 95% CI: -1.54 to 0.94, p = 0.64; low quality, 1 RCT, 90 patients, WMD -1.00, 95% CI: -0.24 to 2.24, p = 0.11) respectively. Similarly, the pooled results were not statistically or clinically different between groups for function at 3-, 6-month and 1-year follow ups (very low quality, 2 RCTs, 184 patients, SMD 0.11, 95% CI: -0.57 to 0.79, p = 0.75; moderate quality, 3 RCTs, 310 patients, SMD 0.15, 95% CI: -0.14 to 0.43, p = 0.31; very low quality, 2 RCTs, 197 patients, SMD 0.11, 95% CI: -0.46 to 0.69, p = 0.70) respectively.
The effects of surgery plus physiotherapy compared to physiotherapy alone on improving pain and function are too small to be clinically important at 3-, 6-months, 1-, 2-, 5- and ≥ 10-years follow up.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
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