ACL TearNCT05532189
Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing
A study testing ACL reconstruction with BTB autograft with internal brace augmentation (suture tape), ACL reconstruction with BTB autograft without internal brace augmentation (suture tape) and Standardized Rehabilitation Protocol in people with ACL Tear, run by Columbia University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- ACL Tear
- What is being tested?
- ACL reconstruction with BTB autograft with internal brace augmentation (suture tape), ACL reconstruction with BTB autograft without internal brace augmentation (suture tape) and Standardized Rehabilitation Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2032
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: ACL Reconstruction With Bone Tendon Bone (BTB) Autograft With Versus Without Internal Brace - Clinical and Radiographic Outcomes
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.
Read the detailed description
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.
- Conditions
- ACL Tear
- Being tested
- ACL reconstruction with BTB autograft with internal brace augmentation (suture tape), ACL reconstruction with BTB autograft without internal brace augmentation (suture tape), Standardized Rehabilitation Protocol
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)Procedure or surgery
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.
ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)Procedure or surgery
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.
Standardized Rehabilitation ProtocolOther
Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy
| Study group | Role | What they receive |
|---|---|---|
| ACL reconstruction with internal brace augmentation (suture tape) | Experimental | 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. Receives: Procedure: ACL reconstruction with BTB autograft with internal brace augmentation (suture tape); Other: Standardized Rehabilitation Protocol |
| ACL reconstruction without internal brace augmentation | Active comparator | 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. Receives: Procedure: ACL reconstruction with BTB autograft without internal brace augmentation (suture tape); Other: Standardized Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 10 years
Secondary outcomes (48)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 )
Measured: 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 )
Measured: 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 )
Measured: 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 )
Measured: 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 )
Measured: 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 )
Measured: 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 )
Measured: 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 )
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study startSep 2026 (estimated)
- Primary completionSep 2032 (estimated)
- Study completionSep 2032 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ACL TearStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David P Trofa, MD, Principal investigator, Associate Professor of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532189
- Sponsor's protocol ID
- AAAU0966
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mall NA, Chalmers PN, Moric M, Tanaka MJ, Cole BJ, Bach BR Jr, Paletta GA Jr. Incidence and trends of anterior cruciate ligament reconstruction in the United States. Am J Sports Med. 2014 Oct;42(10):2363-70. doi: 10.1177/0363546514542796. Epub 2014 Aug 1.
PubMed 25086064Cohen SB, Yucha DT, Ciccotti MC, Goldstein DT, Ciccotti MA, Ciccotti MG. Factors affecting patient selection of graft type in anterior cruciate ligament reconstruction. Arthroscopy. 2009 Sep;25(9):1006-10. doi: 10.1016/j.arthro.2009.02.010.
PubMed 19732639Spindler KP, Wright RW. Clinical practice. Anterior cruciate ligament tear. N Engl J Med. 2008 Nov 13;359(20):2135-42. doi: 10.1056/NEJMcp0804745. No abstract available.
PubMed 19005197Engebretsen L, Benum P, Fasting O, Molster A, Strand T. A prospective, randomized study of three surgical techniques for treatment of acute ruptures of the anterior cruciate ligament. Am J Sports Med. 1990 Nov-Dec;18(6):585-90. doi: 10.1177/036354659001800605.
PubMed 2285086Bowman EN, Limpisvasti O, Cole BJ, ElAttrache NS. Anterior Cruciate Ligament Reconstruction Graft Preference Most Dependent on Patient Age: A Survey of United States Surgeons. Arthroscopy. 2021 May;37(5):1559-1566. doi: 10.1016/j.arthro.2021.01.042. Epub 2021 Feb 1.
PubMed 33539983Bodendorfer BM, Michaelson EM, Shu HT, Apseloff NA, Spratt JD, Nolton EC, Argintar EH. Suture Augmented Versus Standard Anterior Cruciate Ligament Reconstruction: A Matched Comparative Analysis. Arthroscopy. 2019 Jul;35(7):2114-2122. doi: 10.1016/j.arthro.2019.01.054. Epub 2019 Jun 2.
PubMed 31167738Parkes CW, Leland DP, Levy BA, Stuart MJ, Camp CL, Saris DBF, Krych AJ. Hamstring Autograft Anterior Cruciate Ligament Reconstruction Using an All-Inside Technique With and Without Independent Suture Tape Reinforcement. Arthroscopy. 2021 Feb;37(2):609-616. doi: 10.1016/j.arthro.2020.09.002. Epub 2020 Nov 2.
PubMed 33144236Batty LM, Norsworthy CJ, Lash NJ, Wasiak J, Richmond AK, Feller JA. Synthetic devices for reconstructive surgery of the cruciate ligaments: a systematic review. Arthroscopy. 2015 May;31(5):957-68. doi: 10.1016/j.arthro.2014.11.032. Epub 2015 Jan 22.
PubMed 25620500Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.
PubMed 28224069E A Mackenzie C, Huntington LS, Tulloch S. Suture Tape Augmentation of Anterior Cruciate Ligament Reconstruction Increases Biomechanical Stability: A Scoping Review of Biomechanical, Animal, and Clinical Studies. Arthroscopy. 2022 Jun;38(6):2073-2089. doi: 10.1016/j.arthro.2021.12.036. Epub 2022 Jan 3.
PubMed 34990759
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACL Reconstruction With Bone Tendon Bone (BTB) Autograft With Versus Without Internal Brace - Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT05532189
- Acronym / sponsor ID
- AAAU0966
- Conditions
- ACL Tear
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to the ACL reconstruction without internal bracing group (control) or to the ACL reconstruction with internal bracing (experimental).
| Arm | Type | Receives |
|---|---|---|
| ACL reconstruction with internal brace augmentation (suture tape) | Experimental | Procedure: ACL reconstruction with BTB autograft with internal brace augmentation (suture tape), Other: Standardized Rehabilitation ProtocolThis 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. |
| ACL reconstruction without internal brace augmentation | Active comparator | Procedure: ACL reconstruction with BTB autograft without internal brace augmentation (suture tape), Other: Standardized Rehabilitation ProtocolThis 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)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. | Procedure or surgery | ACL reconstruction with internal brace augmentation (suture tape) |
| ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)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. | Procedure or surgery | ACL reconstruction without internal brace augmentation |
| Standardized Rehabilitation ProtocolParticipants will undergo a standardized rehabilitation protocol with twice weekly physical therapy | Other | ACL reconstruction with internal brace augmentation (suture tape), ACL reconstruction without internal brace augmentation |
Primary outcome
Time to Return to Full Activity or Sports
Time frame: Measured once per participant, depending on the time required to return to full activity (up to 10 years)
Time from treatment initiation to full return to pre-injury activity levels in each group, expressed in weeks
Percentage of Participants with Recurrent Knee Instability
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Percentage of participants that experience recurrent instability after treatment starts at each time point
Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks
Time frame: Baseline and 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.
Change in PROMIS PF CAT at 6 weeks
Time frame: Baseline and 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.
Change in PROMIS PF CAT at 3 months
Time frame: Baseline and 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.
Change in PROMIS PF CAT at 6 months
Time frame: Baseline and 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.
Change in PROMIS PF CAT at 1 year
Time frame: Baseline and 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.
Change in PROMIS PF CAT at 2 years
Time frame: Baseline and 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.
Change in PROMIS PF CAT at 5 years
Time frame: Baseline and 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.
Change in PROMIS PF CAT at 10 years
Time frame: Baseline and 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.
Change in PROMIS Pain Interference (PI) CAT at 2 weeks
Time frame: Baseline and 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.
Change in PROMIS PI CAT at 6 weeks
Time frame: Baseline and 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.
Change in PROMIS PI CAT at 3 months
Time frame: Baseline and 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.
Change in PROMIS PI CAT at 6 months
Time frame: Baseline and 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.
Change in PROMIS PI CAT at 1 year
Time frame: Baseline and 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.
Change in PROMIS PI CAT at 2 years
Time frame: Baseline and 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.
Change in PROMIS PI CAT at 5 years
Time frame: Baseline and 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.
Change in PROMIS PI CAT at 10 years
Time frame: Baseline and 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.
Change in PROMIS Depression CAT at 2 weeks
Time frame: Baseline and 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.
Change in PROMIS Depression CAT at 6 weeks
Time frame: Baseline and 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.
Change in PROMIS Depression CAT at 3 months
Time frame: Baseline and 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.
Change in PROMIS Depression CAT at 6 months
Time frame: Baseline and 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.
Change in PROMIS Depression CAT at 1 year
Time frame: Baseline and 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.
Change in PROMIS Depression CAT at 2 years
Time frame: Baseline and 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.
Change in PROMIS Depression CAT at 5 years
Time frame: Baseline and 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.
Change in PROMIS Depression CAT at 10 years
Time frame: Baseline and 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.
48 secondary outcomes
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks
Time frame: Baseline and 2 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks
Time frame: Baseline and 6 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months
Time frame: Baseline and 3 months
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months
Time frame: Baseline and 6 months
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 year
Time frame: Baseline and 1 year
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 years
Time frame: Baseline and 2 years
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 5 years
Time frame: Baseline and 5 years
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 10 years
Time frame: Baseline and 10 years
Change in International Knee Documentation Committee (IKDC) Score at 2 weeks
Time frame: Baseline and 2 weeks
Change in International Knee Documentation Committee (IKDC) Score at 6 weeks
Time frame: Baseline and 6 weeks
Change in International Knee Documentation Committee (IKDC) Score at 3 months
Time frame: Baseline and 3 months
Change in International Knee Documentation Committee (IKDC) Score at 6 months
Time frame: Baseline and 6 months
Change in International Knee Documentation Committee (IKDC) Score at 1 year
Time frame: Baseline and 1 year
Change in International Knee Documentation Committee (IKDC) Score at 2 years
Time frame: Baseline and 2 years
Change in International Knee Documentation Committee (IKDC) Score at 5 years
Time frame: Baseline and 5 years
Change in International Knee Documentation Committee (IKDC) Score at 10 years
Time frame: Baseline and 10 years
Change in numeric pain rating scale (NPRS) Score at 2 weeks
Time frame: Baseline and 2 weeks
Change in numeric pain rating scale (NPRS) Score at 6 weeks
Time frame: Baseline and 6 weeks
Change in numeric pain rating scale (NPRS) Score at 3 months
Time frame: Baseline and 3 months
Change in numeric pain rating scale (NPRS) Score at 6 months
Time frame: Baseline and 6 months
Change in numeric pain rating scale (NPRS) Score at 1 year
Time frame: Baseline and 1 year
Change in numeric pain rating scale (NPRS) Score at 2 years
Time frame: Baseline and 2 years
Change in numeric pain rating scale (NPRS) Score at 5 years
Time frame: Baseline and 5 years
Change in numeric pain rating scale (NPRS) Score at 10 years
Time frame: Baseline and 10 years
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 weeks
Time frame: Baseline and 2 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
Time frame: Baseline and 6 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
Time frame: Baseline and 3 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
Time frame: Baseline and 6 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 year
Time frame: Baseline and 1 year
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 years
Time frame: Baseline and 2 years
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 5 years
Time frame: Baseline and 5 years
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 years
Time frame: Baseline and 10 years
Change in Tegner activity scale (TAS) Score at 2 weeks
Time frame: Baseline and 2 weeks
Change in Tegner activity scale (TAS) Score at 6 weeks
Time frame: Baseline and 6 weeks
Change in Tegner activity scale (TAS) Score at 3 months
Time frame: Baseline and 3 months
Change in Tegner activity scale (TAS) Score at 6 months
Time frame: Baseline and 6 months
Change in Tegner activity scale (TAS) Score at 1 year
Time frame: Baseline and 1 year
Change in Tegner activity scale (TAS) Score at 2 years
Time frame: Baseline and 2 years
Change in Tegner activity scale (TAS) Score at 5 years
Time frame: Baseline and 5 years
Change in Tegner activity scale (TAS) Score at 10 years
Time frame: Baseline and 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 25086064Mall NA, Chalmers PN, Moric M, Tanaka MJ, Cole BJ, Bach BR Jr, Paletta GA Jr. Incidence and trends of anterior cruciate ligament reconstruction in the United States. Am J Sports Med. 2014 Oct;42(10):2363-70. doi: 10.1177/0363546514542796. Epub 2014 Aug 1.
- Background: PubMed 19732639Cohen SB, Yucha DT, Ciccotti MC, Goldstein DT, Ciccotti MA, Ciccotti MG. Factors affecting patient selection of graft type in anterior cruciate ligament reconstruction. Arthroscopy. 2009 Sep;25(9):1006-10. doi: 10.1016/j.arthro.2009.02.010.
- Background: PubMed 19005197Spindler KP, Wright RW. Clinical practice. Anterior cruciate ligament tear. N Engl J Med. 2008 Nov 13;359(20):2135-42. doi: 10.1056/NEJMcp0804745. No abstract available.
- Background: PubMed 2285086Engebretsen L, Benum P, Fasting O, Molster A, Strand T. A prospective, randomized study of three surgical techniques for treatment of acute ruptures of the anterior cruciate ligament. Am J Sports Med. 1990 Nov-Dec;18(6):585-90. doi: 10.1177/036354659001800605.
- Background: PubMed 33539983Bowman EN, Limpisvasti O, Cole BJ, ElAttrache NS. Anterior Cruciate Ligament Reconstruction Graft Preference Most Dependent on Patient Age: A Survey of United States Surgeons. Arthroscopy. 2021 May;37(5):1559-1566. doi: 10.1016/j.arthro.2021.01.042. Epub 2021 Feb 1.
- Background: PubMed 31167738Bodendorfer BM, Michaelson EM, Shu HT, Apseloff NA, Spratt JD, Nolton EC, Argintar EH. Suture Augmented Versus Standard Anterior Cruciate Ligament Reconstruction: A Matched Comparative Analysis. Arthroscopy. 2019 Jul;35(7):2114-2122. doi: 10.1016/j.arthro.2019.01.054. Epub 2019 Jun 2.
- Background: PubMed 33144236Parkes CW, Leland DP, Levy BA, Stuart MJ, Camp CL, Saris DBF, Krych AJ. Hamstring Autograft Anterior Cruciate Ligament Reconstruction Using an All-Inside Technique With and Without Independent Suture Tape Reinforcement. Arthroscopy. 2021 Feb;37(2):609-616. doi: 10.1016/j.arthro.2020.09.002. Epub 2020 Nov 2.
- Background: PubMed 25620500Batty LM, Norsworthy CJ, Lash NJ, Wasiak J, Richmond AK, Feller JA. Synthetic devices for reconstructive surgery of the cruciate ligaments: a systematic review. Arthroscopy. 2015 May;31(5):957-68. doi: 10.1016/j.arthro.2014.11.032. Epub 2015 Jan 22.
- Background: PubMed 28224069Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.
- Background: PubMed 34990759E A Mackenzie C, Huntington LS, Tulloch S. Suture Tape Augmentation of Anterior Cruciate Ligament Reconstruction Increases Biomechanical Stability: A Scoping Review of Biomechanical, Animal, and Clinical Studies. Arthroscopy. 2022 Jun;38(6):2073-2089. doi: 10.1016/j.arthro.2021.12.036. Epub 2022 Jan 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P Trofa, MD principal investigator
Associate Professor of Orthopaedic Surgery
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction with BTB autograft with internal brace augmentation (suture tape), ACL reconstruction with BTB autograft without internal brace augmentation (suture tape) and Standardized Rehabilitation Protocol in people with ACL Tear, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Return to Full Activity or Sports (time frame: Measured once per participant, depending on the time required to return to full activity (up to 10 years)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532189, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.