Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing

Study Overview
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Brief Summary
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There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.

Detailed Description
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Despite the wide variety of surgical approaches and grafts that can be used in an ACL reconstruction, graft failure and recurrent knee instability are nevertheless ubiquitous issues that have facilitated interest in ways to strengthen the graft at the time of surgery. While both animal and biomechanical models have strongly suggested improved graft strength and patient outcomes by utilizing suture tape augmentation in ACL reconstructions, there is scant clinical literature available to assess these extrapolations. A retrospective cohort study of 60 patients undergoing ACL reconstruction with a hamstring autograft or allograft (30 suture tape vs 30 no suture tape; mean age: 30), found shorter time to return to activity (9.2 months suture tape group vs 12.9 months no suture tape group; p=0.002), lower Western Ontario and McMaster University Osteoarthritis Indices (WOMAC) (2.2 suture tape group vs 6.2 no suture tape group; p=0.024), higher international knee documentation committee (IKDC) scores (87.6 suture tape group vs 73.2 no suture tape group; p=0.006), lower average pain on the national pain rating scale (NPRS) (0.6 suture tape group vs 1.66 no suture tape group; p=0.021) and no significant difference in range of motion in degrees (129 suture tape group vs 127 no suture tape group; p=0.46), knee injury and osteoarthritis outcome score (KOOS) (92.2 suture tape group vs 87.1 no suture tape group; p=0.68), or complications (13% suture tape vs 10% no suture tape; p>0.05) at 2 years follow up. A retrospective cohort study of 108 patients undergoing ACL reconstruction with a hamstring autograft with and without suture tape reinforcement (36 suture tape vs 72 no suture tape; mean age: 25), found a significantly higher Tegner activity score (7.1 suture tape group vs 6.4 no suture tape group; p=0.026) but otherwise no significant difference in time to preinjury activity level (11.9 mos suture tape group vs 11.6 no suture tape group; p=0.59), range of motion (degrees) (136 suture tape group vs 137 no suture tape group; p=0.44) , Lysholm knee score (95.6 suture tape group vs 94 no suture tape group; p=0.165), IKDC score (94.4 suture tape group vs 93.8 no suture tape group; p=0.44), or complications (6% suture tape group vs 5% no suture tape group; p>0.05) at 2 years follow up. A prospective cohort study of 50 ACL reconstructions with hamstring autograft with and without suture tape reinforcement (25 suture tape group vs 25 no suture tape group; mean age: 30), found a significant improvement in greater than 2 grades of Lachman testing from preoperative assessment compared to 6 months follow-up (68% suture tape group vs 32% no suture tape group; p=0.039) but no difference in Lysholm knee score at 6 months (87.0 suture tape group vs 87.0 no suture tape group; p=0.756). Moreover, none of the already-limited clinical data investigates the use of internal braces with bone-tendon-bone grafts, which are a popular choice for young adults and athletes. Furthermore, there are no current level 1 data on this subject. Therefore, this study aims to compare the time to return to pre- injury activity level, incidence of recurrent knee instability, and patient reported outcomes of patients treated with ACL reconstruction using bone-tendon-bone autograft with and without (control group) internal brace stabilization.

Official Title
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ACL Reconstruction With Bone Tendon Bone (BTB) Autograft With Versus Without Internal Brace - Clinical and Radiographic Outcomes

Conditions
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ACL Tear

Intervention / Treatment
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* Procedure: ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)
* Procedure: ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)
* Other: Standardized Rehabilitation Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 12 and older patients seen by the Columbia University Sports Medicine Service patients diagnosed with a first time ACL injury by clinical exam and MRI Exclusion Criteria: previous knee surgery concurrent knee fracture or ligamentous injury on ipsilateral knee neuromuscular disorder involving lower limb inability/ unwillingness to adhere to protocol anesthesia contraindications lost to follow up

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to the ACL reconstruction without internal bracing group (control) or to the ACL reconstruction with internal bracing (experimental).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACL reconstruction with internal brace augmentation (suture tape)<br>This group will receive a standard ACL reconstruction using a BTB autograft with suture tape augmentation on the graft to strengthen it during the surgical procedure. | Procedure: ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)<br>* The ACL will be reconstructed using a participant's own patella tendon (BTB autograft), and the graft will be fortified by suture tape during the surgery in order to strengthen it.<br>Other: Standardized Rehabilitation Protocol<br>* Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy<br>|
| Active Comparator: ACL reconstruction without internal brace augmentation<br>This group will only receive a standard ACL reconstruction using a BTB autograft. No suture tape will be added to the graft during the surgical procedure. | Procedure: ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)<br>* The ACL will be reconstructed using a participant's own patella tendon (BTB autograft). The graft will not be fortified by suture tape in this group. It will be used as is without any modification.<br>Other: Standardized Rehabilitation Protocol<br>* Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Return to Full Activity or Sports | Time from treatment initiation to full return to pre-injury activity levels in each group, expressed in weeks | Measured once per participant, depending on the time required to return to full activity (up to 10 years) | 
| Percentage of Participants with Recurrent Knee Instability | Percentage of participants that experience recurrent instability after treatment starts at each time point | 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years | 
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 2 weeks | 
| Change in PROMIS PF CAT at 6 weeks | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 6 weeks | 
| Change in PROMIS PF CAT at 3 months | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 3 months | 
| Change in PROMIS PF CAT at 6 months | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 6 months | 
| Change in PROMIS PF CAT at 1 year | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 1 year | 
| Change in PROMIS PF CAT at 2 years | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 2 years | 
| Change in PROMIS PF CAT at 5 years | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 5 years | 
| Change in PROMIS PF CAT at 10 years | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 10 years | 
| Change in PROMIS Pain Interference (PI) CAT at 2 weeks | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 2 weeks | 
| Change in PROMIS PI CAT at 6 weeks | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 6 weeks | 
| Change in PROMIS PI CAT at 3 months | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 3 months | 
| Change in PROMIS PI CAT at 6 months | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 6 months | 
| Change in PROMIS PI CAT at 1 year | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 1 year | 
| Change in PROMIS PI CAT at 2 years | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 2 years | 
| Change in PROMIS PI CAT at 5 years | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 5 years | 
| Change in PROMIS PI CAT at 10 years | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 10 years | 
| Change in PROMIS Depression CAT at 2 weeks | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 2 weeks | 
| Change in PROMIS Depression CAT at 6 weeks | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 6 weeks | 
| Change in PROMIS Depression CAT at 3 months | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 3 months | 
| Change in PROMIS Depression CAT at 6 months | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 6 months | 
| Change in PROMIS Depression CAT at 1 year | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 1 year | 
| Change in PROMIS Depression CAT at 2 years | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 2 years | 
| Change in PROMIS Depression CAT at 5 years | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 5 years | 
| Change in PROMIS Depression CAT at 10 years | A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. | Baseline and 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks | The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. | Baseline and 2 weeks | 
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks | The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. | Baseline and 6 weeks | 
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months | The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. | Baseline and 3 months | 
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months | The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. | Baseline and 6 months | 
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 year | The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. | Baseline and 1 year | 
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 years | The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. | Baseline and 2 years | 
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 5 years | The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. | Baseline and 5 years | 
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 10 years | The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. | Baseline and 10 years | 
| Change in International Knee Documentation Committee (IKDC) Score at 2 weeks | The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. | Baseline and 2 weeks | 
| Change in International Knee Documentation Committee (IKDC) Score at 6 weeks | The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. | Baseline and 6 weeks | 
| Change in International Knee Documentation Committee (IKDC) Score at 3 months | The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. | Baseline and 3 months | 
| Change in International Knee Documentation Committee (IKDC) Score at 6 months | The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. | Baseline and 6 months | 
| Change in International Knee Documentation Committee (IKDC) Score at 1 year | The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. | Baseline and 1 year | 
| Change in International Knee Documentation Committee (IKDC) Score at 2 years | The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. | Baseline and 2 years | 
| Change in International Knee Documentation Committee (IKDC) Score at 5 years | The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. | Baseline and 5 years | 
| Change in International Knee Documentation Committee (IKDC) Score at 10 years | The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. | Baseline and 10 years | 
| Change in numeric pain rating scale (NPRS) Score at 2 weeks | The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) | Baseline and 2 weeks | 
| Change in numeric pain rating scale (NPRS) Score at 6 weeks | The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) | Baseline and 6 weeks | 
| Change in numeric pain rating scale (NPRS) Score at 3 months | The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) | Baseline and 3 months | 
| Change in numeric pain rating scale (NPRS) Score at 6 months | The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) | Baseline and 6 months | 
| Change in numeric pain rating scale (NPRS) Score at 1 year | The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) | Baseline and 1 year | 
| Change in numeric pain rating scale (NPRS) Score at 2 years | The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) | Baseline and 2 years | 
| Change in numeric pain rating scale (NPRS) Score at 5 years | The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) | Baseline and 5 years | 
| Change in numeric pain rating scale (NPRS) Score at 10 years | The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) | Baseline and 10 years | 
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 weeks | The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) | Baseline and 2 weeks | 
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks | The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) | Baseline and 6 weeks | 
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months | The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) | Baseline and 3 months | 
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months | The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) | Baseline and 6 months | 
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 year | The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) | Baseline and 1 year | 
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 years | The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) | Baseline and 2 years | 
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 5 years | The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) | Baseline and 5 years | 
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 years | The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) | Baseline and 10 years | 
| Change in Tegner activity scale (TAS) Score at 2 weeks | TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. | Baseline and 2 weeks | 
| Change in Tegner activity scale (TAS) Score at 6 weeks | TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. | Baseline and 6 weeks | 
| Change in Tegner activity scale (TAS) Score at 3 months | TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. | Baseline and 3 months | 
| Change in Tegner activity scale (TAS) Score at 6 months | TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. | Baseline and 6 months | 
| Change in Tegner activity scale (TAS) Score at 1 year | TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. | Baseline and 1 year | 
| Change in Tegner activity scale (TAS) Score at 2 years | TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. | Baseline and 2 years | 
| Change in Tegner activity scale (TAS) Score at 5 years | TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. | Baseline and 5 years | 
| Change in Tegner activity scale (TAS) Score at 10 years | TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. | Baseline and 10 years | 
| Change in Lysholm Score at 2 weeks | Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. | Baseline and 2 weeks | 
| Change in Lysholm Score at 6 weeks | Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. | Baseline and 6 weeks | 
| Change in Lysholm Score at 3 months | Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. | Baseline and 3 months | 
| Change in Lysholm Score at 6 months | Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. | Baseline and 6 months | 
| Change in Lysholm Score at 1 year | Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. | Baseline and 1 year | 
| Change in Lysholm Score at 2 years | Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. | Baseline and 2 years | 
| Change in Lysholm Score at 5 years | Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. | Baseline and 5 years | 
| Change in Lysholm Score at 10 years | Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. | Baseline and 10 years |