Recruiting

ACL Reconstruction

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06942754

Conditions

Anterior Cruciate Ligament Injuries

Eligibility Criteria

Sex: All

Age: 14 - 39

Healthy Volunteers: Not accepted

Interventions

post-surgical functional bracing

Study Details

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

Study ID

NCT06942754

Start date

Sep 11, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: With postoperative brace (DonJoy Defiance Pro)

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

no intervention: Without post-surgical functional bracing

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

Interventions

post-surgical functional bracing

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

Primary outcome measure

  • Change in ACL-return to sport index (ACL-RSI) Scores [ Time Frame: Baseline and 3, 6, 12, and 24 months ]

Central Contacts and Locations

Central contacts

Katherine Leonard

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

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Katherine Leonard

336-716-3952kmleonar@wakehealth.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-01.