Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

NCT06942754 | Recruiting FDA Device

• 1 other identifier: IRB00123098
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries

Keywords

Anterior Cruciate Ligament (ACL) reconstruction; postoperative bracing; functional bracing

Outcome Measures

Primary Outcomes (1)

• Change in ACL-return to sport index (ACL-RSI) Scores

  The ACL-Return to Sport after Injury scale (ACL-RSI) is a 12-item survey that measures psychological readiness to return to sport after an ACL injury or surgery. It uses a visual analog scale from 0 to 100, where higher scores indicate greater psychological readiness. The total score is calculated as a percentage of the 12-item total score. A higher ACL-RSI score indicates a greater level of psychological readiness for returning to sport.

  Baseline and 3, 6, 12, and 24 months

Secondary Outcomes (20)

• Tampa Scale Kinesiophobia 11 (TSK-11) Score

  Baseline and 3, 6, 12, and 24 months

• International Knee Documentation Committee (IKDC) Score

  Baseline and 3, 6, 12, and 24 months

• Lysholm score

  Baseline and 3, 6, 12, and 24 months

• Forgotten Joint Score (FJS-12)

  Baseline and 3, 6, 12, and 24 months

• SANE Score

  Baseline and 3, 6, 12, and 24 months

Study Arms (2)

With postoperative brace (DonJoy Defiance Pro)

EXPERIMENTAL

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

Device: post-surgical functional bracing

Without post-surgical functional bracing

NO INTERVENTION

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

Interventions

post-surgical functional bracing DEVICE

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

Also known as: DonJoy Defiance Pro brace

With postoperative brace (DonJoy Defiance Pro)

Eligibility Criteria

• Age: 14 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Brian Waterman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Leonard

CONTACT

336-716-3952; Katherine.Leonard@Advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 96 patients will be randomized, which means 48 patients will be in the bracing group and 48 in the non-bracing group, based on a sample size calculation. Patients will be randomized during their 2-week post-op visit.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)