ACL reconstruction with BTB autograft with internal brace augmentation (suture tape) for ACL Tears

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Columbia University Irving Medical Center, New York, NY
ACL Tears+1 More
ACL reconstruction with BTB autograft with internal brace augmentation (suture tape) - Procedure
Eligibility
Any Age
All Sexes
What conditions do you have?
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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

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

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
Photo of New York 1Photo of New York 2Photo of New York 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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