Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Quadriceps Isometric Peak Torque Limb Symmetry Index over the first 12 months following ACL reconstruction surgery |
Quadriceps function will be assessed via maximal voluntary isometric knee extension efforts while patients are seated on a dynamometer with the knee in 90° of flexion. Peak torque will be normalized to body mass. The limb symmetry index will be calculated as the ratio of the ACLR limb to the contralateral limb. |
Up to 12 months post ACL reconstruction surgery |
|
Primary |
Change in peak internal knee extension moment during walking over the first 12 months following ACL reconstruction surgery |
Three-dimensional walking gait biomechanics will be obtained a via a 10-camera motion capture system interfaced with force plates embedded in a walkway. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee extension moment will be identified during the first 50% of stance. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Primary |
Change in vertical ground reaction force instantaneous loading rate over the first 12 months following ACL reconstruction surgery |
The vertical ground reaction force will be sampled from force plates embedded in a walkway during walking gait biomechanics. The instantaneous loading rate during the first 50% of stance will be calculated as the first time derivative of the force vs. time curve and normalized to body weight. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Primary |
Change in KOOS Knee-related Quality of Life Subscale over the first 12 months following ACL reconstruction surgery |
The Knee Injury and Osteoarthritis Outcome Score (KOOS) survey will be administered electronically at all study visits. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Primary |
Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery |
T1rho MRIs will be obtained to assess composition (i.e. proteoglycan concentration) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Primary |
Probability of attaining 90% single-leg hop symmetry at 12 months post-ACLR. |
Single-leg hop for distance will be assessed 12 months post-ACLR in both limbs. Limb symmetry will be calculated as ACLR/Contralateral, and the number of patients who attain 90% symmetry will be compared between the rehabilitation arms. |
Up to 12 months post ACL reconstruction surgery |
|
Primary |
Change in peak internal knee adduction moment during landing over the first 12 months following ACL reconstruction surgery |
Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee adduction moment will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Primary |
Change in quadriceps muscle quality over the first 12 months following ACL reconstruction surgery |
MRI-based calculation of % contractile tissue in each component of the quadriceps muscle |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Quadriceps Isometric Rate of Torque Development Limb Symmetry Index over the first 12 months following ACL reconstruction surgery |
Quadriceps function will be assessed via maximal voluntary isometric knee extension efforts while patients are seated on a dynamometer with the knee in 90° of flexion. Rate of torque development will be calculated as the slope of the torque vs. time curve from 20-80% peak torque and normalized to body mass. The limb symmetry index will be calculated as the ratio of the ACLR limb to the contralateral limb. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in peak internal knee abduction moment over the first 12 months following ACL reconstruction surgery |
Three-dimensional walking gait biomechanics will be obtained a via a 10-camera motion capture system interfaced with force plates embedded in a walkway. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee abduction moment will be identified during the first 50% of stance. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in internal knee extension moment impulse over the first 12 months following ACL reconstruction surgery |
Three-dimensional walking gait biomechanics will be obtained a via a 10-camera motion capture system interfaced with force plates embedded in a walkway. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee extension moment impulse will be identified during the first 50% of stance. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in internal knee abduction moment impulse over the first 12 months following ACL reconstruction surgery |
Three-dimensional walking gait biomechanics will be obtained a via a 10-camera motion capture system interfaced with force plates embedded in a walkway. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee abduction moment impulse will be identified during the first 50% of stance. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in peak knee flexion angle over the first 12 months following ACL reconstruction surgery |
Three-dimensional walking gait biomechanics will be obtained a via a 10-camera motion capture system interfaced with force plates embedded in a walkway. Joint angles will be calculated using an Euler angle sequence. The peak knee flexion angle will be identified during the first 50% of stance. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in peak knee varus angle over the first 12 months following ACL reconstruction surgery |
Three-dimensional walking gait biomechanics will be obtained a via a 10-camera motion capture system interfaced with force plates embedded in a walkway. Joint angles will be calculated using an Euler angle sequence. The peak knee varus angle will be identified during the first 50% of stance. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in peak vertical ground reaction force over the first 12 months following ACL reconstruction surgery |
The vertical ground reaction force will be sampled from force plates embedded in a walkway during walking gait biomechanics. The peak magnitude during the first 50% of stance will be identified and normalized to body weight. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in preparatory quadriceps electromyographic (EMG) amplitude over the first 12 months following ACL reconstruction surgery |
EMG data will be sampled from the quadriceps during walking gait. Mean amplitudes will be calculated over the preparatory phase identified as the 100ms interval prior to heel strike. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in weight acceptance quadriceps EMG amplitude over the first 12 months following ACL reconstruction surgery |
EMG data will be sampled from the quadriceps during walking gait. Mean amplitudes will be calculated over the weight acceptance phase (i.e. first 50% of stance). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in KOOS total score over the first 12 months following ACL reconstruction surgery |
The Knee Injury and Osteoarthritis Outcome Score (KOOS) survey will be administered electronically at all study visits. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in IKDC total score over the first 12 months following ACL reconstruction surgery |
The International Knee Documentation Committee subjective knee form (IKDC) survey will be administered electronically at all study visits. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in ACL-QOL total score over the first 12 months following ACL reconstruction surgery |
The Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QOL) survey will be administered electronically at all study visits. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in TSK-11 total score over the first 12 months following ACL reconstruction surgery |
The Tampa Scale for Kinesiophobia (TSK-11) survey will be administered electronically at all study visits. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in Tegner Activity Scale total score over the first 12 months following ACL reconstruction surgery |
The Tegner Activity Scale survey will be administered electronically at all study visits. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in Marx Activity Rating Scale total score over the first 12 months following ACL reconstruction surgery |
The Marx Activity Rating Scale survey will be administered electronically at all study visits. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in T1rho relaxation time (lateral femoral condyle) over the first 12 months following ACL reconstruction surgery |
T1rho MRIs will be obtained to assess composition (i.e. proteoglycan concentration) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in T1rho relaxation time (medial tibial condyle) over the first 12 months following ACL reconstruction surgery |
T1rho MRIs will be obtained to assess composition (i.e. proteoglycan concentration) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in T1rho relaxation time (lateral tibial condyle) over the first 12 months following ACL reconstruction surgery |
T1rho MRIs will be obtained to assess composition (i.e. proteoglycan concentration) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in T2 relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery |
T2 MRIs will be obtained to assess composition (i.e. water and collagen content) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in T2 relaxation time (lateral femoral condyle) over the first 12 months following ACL reconstruction surgery |
T2 MRIs will be obtained to assess composition (i.e. water and collagen content) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in T2 relaxation time (medial tibial condyle) over the first 12 months following ACL reconstruction surgery |
T2 MRIs will be obtained to assess composition (i.e. water and collagen content) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in T2 relaxation time (lateral tibial condyle) over the first 12 months following ACL reconstruction surgery |
T2 MRIs will be obtained to assess composition (i.e. water and collagen content) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
PTOA incidence 12 months following ACL reconstruction surgery |
T2-weighted fat suppressed MRIs will be evaluated using a subjective rating scale called the MRI Osteoarthritis Knee Score (MOAKS) to identify the presence/absence of post-traumatic osteoarthritis (PTOA) at Baseline (1 month) and 12 months. Logistic regression and odds ratios will be used to determine the influence of the interventions on PTOA incidence at 12 months in individuals who do not display PTOA at Baseline. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Probability of attaining 90% quadriceps strength symmetry at 12 months post-ACLR. |
Isometric quadriceps strength will be assessed 12 months post-ACLR in both limbs. Limb symmetry will be calculated as ACLR/Contralateral, and the number of patients who attain 90% symmetry will be compared between the rehabilitation arms. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Probability of attaining 90% triple hop for distance symmetry at 12 months post-ACLR. |
Triple hop for distance will be assessed 12 months post-ACLR in both limbs. Limb symmetry will be calculated as ACLR/Contralateral, and the number of patients who attain 90% symmetry will be compared between the rehabilitation arms. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Probability of attaining 90% crossover hop for distance symmetry at 12 months post-ACLR. |
Crossover hop for distance will be assessed 12 months post-ACLR in both limbs. Limb symmetry will be calculated as ACLR/Contralateral, and the number of patients who attain 90% symmetry will be compared between the rehabilitation arms. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in peak internal knee extension moment during landing over the first 12 months following ACL reconstruction surgery |
Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee extension moment will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in peak knee flexion angle during landing over the first 12 months following ACL reconstruction surgery |
Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. The peak knee flexion angle will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in peak knee valgus angle during landing over the first 12 months following ACL reconstruction surgery |
Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. The peak knee valgus angle will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in peak vertical ground reaction force during landing over the first 12 months following ACL reconstruction surgery |
Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. The peak vertical ground reaction force will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in preparatory quadriceps EMG amplitude during landing over the first 12 months following ACL reconstruction surgery |
Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. Preparatory quadriceps EMG amplitude will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|
Secondary |
Change in preparatory hamstrings EMG amplitude during landing over the first 12 months following ACL reconstruction surgery |
Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. Preparatory hamstrings EMG amplitude will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables. |
Up to 12 months post ACL reconstruction surgery |
|