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Recruiting NCT06542705

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

No phase Interventional ACL Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arthrex Internal Brace, ACL Reconstruction.
Who it may be relevant to
Registry conditions: ACL Reconstruction. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial

Overview

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.

Interventions

  • Device Arthrex Internal Brace
    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.
  • Procedure ACL Reconstruction
    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.

Primary outcome measures

  • Side to side difference in laxity as measured by the KT-1000 Arthrometer [Time frame: Month 12 Post-Operation]
  • Side to side difference in laxity as measured by the KT-1000 Arthrometer [Time frame: Month 24 Post-Operation]
Secondary outcome measures (9)
  • Pivot Shift Grade [Time frame: Month 12 Post-Operation]
  • Pivot Shift Grade [Time frame: Month 24 Post-Operation]
  • Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation [Time frame: Baseline, Month 12 Post-Operation]
  • Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 24 Post-Operation [Time frame: Baseline, Month 24 Post-Operation]
  • Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 12 Post-Operation [Time frame: Baseline, Month 12 Post-Operation]
  • Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 24 Post-Operation [Time frame: Baseline, Month 24 Post-Operation]
  • Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation [Time frame: Baseline, Month 12 Post-Operation]
  • Change from Baseline in Lysholm Knee Scoring System Score at Month 24 Post-Operation [Time frame: Baseline, Month 24 Post-Operation]
  • Tegner Activity Level Scale [Time frame: Month 24 Post-Operation]

Eligibility criteria

Inclusion criteria

  • Patients undergoing ACLR with BTB autograft
  • Patients ages 18-35, inclusive
  • Ability to undergo standard rehab protocol and full, painless range of motion at the time of surgery of their operative knee

Exclusion criteria

  • Osteoarthritis defined by Kellgren-Lawrence grade 2 or higher on preoperative weightbearing radiographs
  • Significant chondral injury as defined by grade 3-4 lesion greater than 2cm2
  • History of autoimmune or inflammatory disease
  • Prior ipsilateral knee ligament surgery or multi-ligament knee injury
  • Concomitant Lateral extra-articular tenodesis (LET) procedure
  • History of contralateral ACL surgery
  • Younger than 18 years of age
  • Older than 35 years of age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06542705 · 24-00423

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗