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

NCT05532189 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-09-22

No results posted yet for this 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.

Conditions

  • ACL Tear

Interventions

PROCEDURE

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

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.

PROCEDURE

ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)

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.

OTHER

Standardized Rehabilitation Protocol

Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy

Sponsors & Collaborators

Principal Investigators

  • David P Trofa, MD · Associate Professor of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2032-09-30
Completion
2032-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532189 on ClinicalTrials.gov