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

NYU Langone Health

Status: Enrolling

Conditions: ACL Reconstruction

Treatments: Procedure: ACL Reconstruction; Device: Arthrex Internal Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT06542705

24-00423

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Internal Brace

Experimental group

Description:

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.

Treatment:

Device: Arthrex Internal Brace

Procedure: ACL Reconstruction

Standard ACLR

Active Comparator group

Description:

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.

Treatment:

Procedure: ACL Reconstruction