Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft

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

Sponsor
NYU Langone Health
Study ID
NCT06542705
Status
Recruiting
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Conditions

  • ACL Reconstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Arthrex Internal Brace — DEVICE
    The Arthrex Internal Brace method for ACL reconstruction consists of suture tape used to reinforce the ACL during surgery. This suture tape is secured in place with bioabsorbable anchors that gradually degrade within the body over time.
  • ACL Reconstruction — PROCEDURE
    All patients will undergo ACL reconstruction (ACLR) with or without an internal brace. ACLR technique will be standardized to standard anteromedial (AM) portal femoral drilling to ensure consistency between surgeons.

Study Details

The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with bone-tendon-bone autograft with and without internal bracing.

Key Dates

Start date
Mar 17, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

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

Arms

  • Experimental: Internal Brace
    Patients will undergo ACL Reconstruction (ACLR) with an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted.
  • Active Comparator: Standard ACLR
    Patients will undergo ACLR without an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted.

Primary Outcome Measure

Side to side difference in laxity as measured by the KT-1000 Arthrometer [ Time Frame: Month 12 Post-Operation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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