Clinical trial NCT06942754: Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial
Official title: Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE-trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: Anterior Cruciate Ligament (ACL) reconstruction
postoperative bracing
functional bracing
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 96
Sex: ALL
Minimum age (years): 14
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Change in ACL-return to sport index (ACL-RSI) Scores
timeFrame: Baseline and 3, 6, 12, and 24 months
Secondary outcomes:
measure: Tampa Scale Kinesiophobia 11 (TSK-11) Score
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: International Knee Documentation Committee (IKDC) Score
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: Lysholm score
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: Forgotten Joint Score (FJS-12)
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: SANE Score
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: 5-point Likert Scale for Surgery Satisfaction Score
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: Pain Visual Analog Scale (Pain - VAS) Score
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: Lachmeter
timeFrame: Baseline and Months 3, 6, 12, and 24
measure: Lachman pivot shift
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: Lachman anterior drawer
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: Tegner Activity Score
timeFrame: Baseline and 3, 6, 12, and 24 months
measure: Time to Return to Sport/Previous Activity Level
timeFrame: Months 3, 6, 12, and 24
measure: Y-Balance Distance
timeFrame: Months 6, 12, and 24
measure: Number of Single Hop
timeFrame: Months 6, 12, and 24
measure: Number of Triple Hops
timeFrame: Months 6, 12, and 24
measure: Biodex Strength Testing
timeFrame: Months 6, 12, and 24
measure: Reoperation Rate
timeFrame: Months 3, 6, 12, and 24
measure: Failure Rate
timeFrame: Months 3, 6, 12, and 24
measure: Brace Compliance Rate
timeFrame: Months 6, 12, and 24
measure: Number of Brace Complications
timeFrame: Months 6, 12, and 24
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Brian Waterman, MD
role: PRINCIPAL_INVESTIGATOR
References: