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

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05532189
Status
Not Yet Recruiting

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Conditions

  • ACL Tear

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ACL reconstruction with BTB autograft with internal brace augmentation (suture tape) — PROCEDURE
    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
    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 Protocol — OTHER
    Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Sep 2025
Primary completion
Sep 30, 2032
Completion
Sep 30, 2032

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ACL reconstruction with internal brace augmentation (suture tape)
    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.
  • Active Comparator: ACL reconstruction without internal brace augmentation
    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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
David P Trofa, MD
[email protected]
212-305-5974
David P Trofa, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center· New York, NY

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