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.
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.
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.
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.
Columbia University Irving Medical Center
New York, New York, United States
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 10 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 )
Time frame: 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 )
Time frame: 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 )
Time frame: 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 )
Time frame: 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 )
Time frame: 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 )
Time frame: 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 )
Time frame: 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 )
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 10 years