Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

NCT ID: NCT06942754

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-11
• Study Completion Date: 2028-12-31

Brief Summary

Several attempts have been made to reduce these failure rates and improve return to sports rates in high-risk populations, and one of these approaches has been postoperative bracing. A recent survey of the Anterior cruciate ligament (ACL) Study Group has shown that 53% of surgeons prefers functional bracing following ACL reconstruction. Currently, however, there is no clear consensus on whether functional bracing following ACL reconstruction leads to lower failure rates, improved stability or better patient-reported outcomes when compared to ACL reconstruction without bracing.

Detailed Description

Given the increased popularity in quadriceps tendon graft, the biomechanical advantages of postoperative functional bracing, and the graft elongation that occurs predominantly with soft tissue grafts, there might be a role for functional bracing following quadriceps ACL reconstruction. Additionally, no studies to date have assessed the role of psychological readiness of return to sport, kinesiophobia and return to sport rates with and without functional bracing following ACL reconstruction (ACLR).

The purpose of this randomized controlled trial is to assess the 2-year outcomes of psychological readiness, patient-reported outcome measures (PROMs), clinical stability, return to sport and failure rates following quadriceps autograft ACL reconstruction with and without functional bracing in the postoperative phase in younger athletic patients and military patients with a higher risk of failure or not returning to sports or duty, respectively, in a randomized study: the Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy trial (BRACE-trial).

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

With postoperative brace (DonJoy Defiance Pro)

Quadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace

Group Type: EXPERIMENTAL

post-surgical functional bracing

Intervention Type: DEVICE

Quadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace

Without post-surgical functional bracing

Quadriceps Autograft ACL Reconstruction without the use of post-surgical functional bracing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

post-surgical functional bracing

Quadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace

Intervention Type: DEVICE

Other Intervention Names

DonJoy Defiance Pro brace

Eligibility Criteria

Inclusion Criteria

• patients with unilateral complete ACL injury
• patients involved in sports and the desire to return to sports
• patients undergoing quadriceps autograft ACL reconstruction
• must be 14 to 39 years old

Exclusion Criteria

• multiligamentous knee injuries defined as two ligaments requiring surgical stabilization
• concomitant suture tape augmentation, extra-articular tenodesis or anterolateral ligament reconstruction
• concomitant femoral, tibial, or patellar fracture(s)
• patients with significant osteoarthritis
• concomitant ipsilateral knee dislocation or patellar dislocation
• significant lower leg malalignment requiring correcting osteotomies
• prior ACL surgery, including contralateral knee
• pregnancy during injury or surgery
• unable to provide consent
• prolonged use of prednisolone or cytostatics
• comorbidities (e.g., muscular, neurological, vascular) that influence rehabilitation

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Waterman, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katherine Leonard

Role: CONTACT

kmleonar@wakehealth.edu

336-716-3952

Facility Contacts

Katherine Leonard

Role: primary

kmleonar@wakehealth.edu

336-716-3952

Other Identifiers

IRB00123098

Identifier Type: -

Identifier Source: org_study_id