ACL reconstruction with BTB autograft with internal brace augmentation (suture tape) for ACL Tears
Phase-Based Progress Estimates
Effectiveness
Safety
Columbia University Irving Medical Center, New York, NY
ACL Tears+1 More
ACL reconstruction with BTB autograft with internal brace augmentation (suture tape) - ProcedureEligibility
Any Age
All Sexes
What conditions do you have?
Select
Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study 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. 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.
Eligible Conditions
- ACL Tears
Treatment Effectiveness
Effectiveness Progress
Other trials for ACL Tears
Study Objectives
26 Primary · 48 Secondary · Reporting Duration: Baseline and 10 years
Year 10
Percentage of Participants with Recurrent Knee Instability
Baseline and 1 year
Change in International Knee Documentation Committee (IKDC) Score at 1 year
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 year
Change in Lysholm Score at 1 year
Change in PROMIS Depression CAT at 1 year
Change in PROMIS PF CAT at 1 year
Change in PROMIS PI CAT at 1 year
Change in Tegner activity scale (TAS) Score at 1 year
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 year
Change in numeric pain rating scale (NPRS) Score at 1 year
Baseline and 10 years
Change in International Knee Documentation Committee (IKDC) Score at 10 years
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 years
Change in Lysholm Score at 10 years
Change in PROMIS Depression CAT at 10 years
Change in PROMIS PF CAT at 10 years
Change in PROMIS PI CAT at 10 years
Change in Tegner activity scale (TAS) Score at 10 years
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 10 years
Change in numeric pain rating scale (NPRS) Score at 10 years
Baseline and 2 weeks
Change in International Knee Documentation Committee (IKDC) Score at 2 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 weeks
Change in Lysholm Score at 2 weeks
Change in PROMIS Depression CAT at 2 weeks
Change in PROMIS Pain Interference (PI) CAT at 2 weeks
Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks
Change in Tegner activity scale (TAS) Score at 2 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks
Change in numeric pain rating scale (NPRS) Score at 2 weeks
Baseline and 2 years
Change in International Knee Documentation Committee (IKDC) Score at 2 years
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 years
Change in Lysholm Score at 2 years
Change in PROMIS Depression CAT at 2 years
Change in PROMIS PF CAT at 2 years
Change in PROMIS PI CAT at 2 years
Change in Tegner activity scale (TAS) Score at 2 years
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 years
Change in numeric pain rating scale (NPRS) Score at 2 years
Baseline and 3 months
Change in International Knee Documentation Committee (IKDC) Score at 3 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
Change in Lysholm Score at 3 months
Change in PROMIS Depression CAT at 3 months
Change in PROMIS PF CAT at 3 months
Change in PROMIS PI CAT at 3 months
Change in Tegner activity scale (TAS) Score at 3 months
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months
Change in numeric pain rating scale (NPRS) Score at 3 months
Baseline and 5 years
Change in International Knee Documentation Committee (IKDC) Score at 5 years
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 5 years
Change in Lysholm Score at 5 years
Change in PROMIS Depression CAT at 5 years
Change in PROMIS PF CAT at 5 years
Change in PROMIS PI CAT at 5 years
Change in Tegner activity scale (TAS) Score at 5 years
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 5 years
Change in numeric pain rating scale (NPRS) Score at 5 years
Baseline and 6 months
Change in International Knee Documentation Committee (IKDC) Score at 6 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
Change in Lysholm Score at 6 months
Change in PROMIS Depression CAT at 6 months
Change in PROMIS PF CAT at 6 months
Change in PROMIS PI CAT at 6 months
Change in Tegner activity scale (TAS) Score at 6 months
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months
Change in numeric pain rating scale (NPRS) Score at 6 months
Baseline and 6 weeks
Change in International Knee Documentation Committee (IKDC) Score at 6 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
Change in Lysholm Score at 6 weeks
Change in PROMIS Depression CAT at 6 weeks
Change in PROMIS PF CAT at 6 weeks
Change in PROMIS PI CAT at 6 weeks
Change in Tegner activity scale (TAS) Score at 6 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks
Change in numeric pain rating scale (NPRS) Score at 6 weeks
Year 10
Time to Return to Full Activity or Sports
Trial Safety
Safety Progress
Other trials for ACL Tears
Trial Design
2 Treatment Groups
ACL reconstruction without internal brace augmentation
1 of 2
ACL reconstruction with internal brace augmentation (suture tape)
1 of 2
Active Control
Experimental Treatment
200 Total Participants · 2 Treatment Groups
Primary Treatment: ACL reconstruction with BTB autograft with internal brace augmentation (suture tape) · No Placebo Group · N/A
ACL reconstruction with internal brace augmentation (suture tape)Experimental Group · 2 Interventions: ACL reconstruction with BTB autograft with internal brace augmentation (suture tape), Standardized Rehabilitation Protocol · Intervention Types: Procedure, Other
ACL reconstruction without internal brace augmentationActiveComparator Group · 2 Interventions: ACL reconstruction with BTB autograft without internal brace augmentation (suture tape), Standardized Rehabilitation Protocol · Intervention Types: Procedure, Other
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 10 years
Closest Location: Columbia University Irving Medical Center · New York, NY
2002First Recorded Clinical Trial
1 TrialsResearching ACL Tears
73 CompletedClinical Trials
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,266 Previous Clinical Trials
1,573,616 Total Patients Enrolled
David Trofa, MDPrincipal InvestigatorAssistant Professor of Orthopedic Surgery
2 Previous Clinical Trials
400 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 3 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a first time ACL injury by clinical exam and MRI.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Bodendorfer, Blake M., Evan M. Michaelson, Henry T. Shu, Nicholas A. Apseloff, James D. Spratt, Esther C. Nolton, and Evan H. Argintar. 2019. “Suture Augmented Versus Standard Anterior Cruciate Ligament Reconstruction: A Matched Comparative Analysis”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2019.01.054.
- Engebretsen, Lars, Pal Benum, Ove Fasting, Anders Mølster, and Torbjørn Strand. 1990. “A Prospective, Randomized Study of Three Surgical Techniques for Treatment of Acute Ruptures of the Anterior Cruciate Ligament”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/036354659001800605.
- Spindler, Kurt P., and Rick W. Wright. 2008. “Anterior Cruciate Ligament Tear”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmcp0804745.
- Batty, Lachlan M., Cameron J. Norsworthy, Nicholas J. Lash, Jason Wasiak, Anneka K. Richmond, and Julian A. Feller. 2015. “Synthetic Devices for Reconstructive Surgery of the Cruciate Ligaments: A Systematic Review”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2014.11.032.
- Mall, Nathan A., Peter N. Chalmers, Mario Moric, Miho J. Tanaka, Brian J. Cole, Bernard R. Bach Jr, and George A. Paletta Jr. 2014. “Incidence and Trends of Anterior Cruciate Ligament Reconstruction in the United States”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546514542796.
- Smith, Patrick A., and Jordan A. Bley. 2016. “Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation”. Arthroscopy Techniques. Elsevier BV. doi:10.1016/j.eats.2016.06.007.
- Cohen, Steven B., David T. Yucha, Michael C. Ciccotti, Daniel T. Goldstein, Matthew A. Ciccotti, and Michael G. Ciccotti. 2009. “Factors Affecting Patient Selection of Graft Type in Anterior Cruciate Ligament Reconstruction”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2009.02.010.
- Bowman, Eric N., Orr Limpisvasti, Brian J. Cole, and Neal S. ElAttrache. 2021. “Anterior Cruciate Ligament Reconstruction Graft Preference Most Dependent on Patient Age: A Survey of United States Surgeons”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2021.01.042.
- Parkes, Chad W., Devin P. Leland, Bruce A. Levy, Michael J. Stuart, Christopher L. Camp, Daniel B.F. Saris, and Aaron J. Krych. 2021. “Hamstring Autograft Anterior Cruciate Ligament Reconstruction Using an All-inside Technique with and Without Independent Suture Tape Reinforcement”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2020.09.002.
- E.A. Mackenzie, Christopher, Lachlan S. Huntington, and Scott Tulloch. 2022. “Suture Tape Augmentation of Anterior Cruciate Ligament Reconstruction Increases Biomechanical Stability: A Scoping Review of Biomechanical, Animal, and Clinical Studies”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2021.12.036.
- David P. Trofa, MD 2022. "Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05532189.
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