Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE)

Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE-trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Device: post-surgical functional 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).

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Leonard; Phone Number: 336-716-3952; Email: Katherine.Leonard@Advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Katherine Leonard; Phone Number: 336-716-3952; Email: kmleonar@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: post-surgical functional bracing; Quadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace; Other Names: DonJoy Defiance Pro brace
No Intervention: Without post-surgical functional bracing; Quadriceps Autograft ACL Reconstruction without the use of post-surgical functional bracing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tampa Scale Kinesiophobia 11 (TSK-11) Score	The TSK-11 (Tampa Scale for Kinesiophobia) is a 11-item questionnaire assessing fear of movement/re-injury, scored on a 4-point Likert scale (1-4) with a total score range of 11-44, where higher scores indicate greater fear of pain and movement. Lower scores (closer to 11): Indicate minimal or no kinesiophobia (fear of movement/re-injury). Higher scores (closer to 44): Suggest a greater degree of kinesiophobia.	Baseline and 3, 6, 12, and 24 months
International Knee Documentation Committee (IKDC) Score	The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)	Baseline and 3, 6, 12, and 24 months
Lysholm score	The Lysholm Knee Scoring Scale is a 100-point questionnaire used to assess knee function and is often used to evaluate knee injuries and surgeries, with higher scores indicating better function and fewer symptoms. A higher score indicates better knee function and fewer symptoms. Scores are often categorized as excellent (95-100), good (84-94), fair (65-83), and poor (<65).	Baseline and 3, 6, 12, and 24 months
Forgotten Joint Score (FJS-12)	The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure designed to assess how much a patient is aware of their artificial join in everyday life, with higher scores indicating less awareness and better surgical outcomes. Each response is assigned a score (0-4), and the scores are summed and transformed to a 0-100 scale, with higher scores indicating less awareness of the joint. Interpretation: A higher score suggests that the patient is less aware of their joint, indicating a better outcome and higher satisfaction with the surgery.	Baseline and 3, 6, 12, and 24 months
SANE Score	The SANE score asks the patient to rate the shoulder on a scale from 0 to 100, with 100 being the patient's normal. Although singular in nature, the SANE score incorporates broad intangible differences in patient-perceived function, quality of life, and goals. SANE scores range from 40% to 60% at baseline for most patients before treatment and range from 75% to 85% at 1 year after therapy depending on the condition	Baseline and 3, 6, 12, and 24 months
5-point Likert Scale for Surgery Satisfaction Score	A 5-point Likert scale for surgery satisfaction typically uses a range from "Very Unsatisfied" to "Very Satisfied" with options like "Very Dissatisfied," "Dissatisfied," "Neutral," "Satisfied," and "Very Satisfied". This scale allows patients to express their level of satisfaction with various aspects of their surgical experience. Very Dissatisfied/Very Unsatisfied (1): Indicates a very negative experience. Dissatisfied/Unsatisfied (2): Indicates a negative experience. Neutral (3): Indicates neither satisfaction nor dissatisfaction. Satisfied (4): Indicates a positive experience. Very Satisfied (5): Indicates a very positive experience.	Baseline and 3, 6, 12, and 24 months
Pain Visual Analog Scale (Pain - VAS) Score	a measurement tool used to gauge subjective experiences, especially pain, by having individuals mark a spot on a continuous line between two defined extremes, representing, for example, "no pain" and "worst pain".	Baseline and 3, 6, 12, and 24 months
Lachmeter	A Lachmeter is a device that is attached above and below your knee, that will measure the laxity (looseness) of your knee.	Baseline and Months 3, 6, 12, and 24
Lachman pivot shift	The Lachman, pivot shift tests are all physical examination techniques used to assess the integrity of the anterior cruciate ligament (ACL) in the knee.	Baseline and 3, 6, 12, and 24 months
Lachman anterior drawer	The Lachman anterior drawer tests are all physical examination techniques used to assess the integrity of the anterior cruciate ligament (ACL) in the knee.	Baseline and 3, 6, 12, and 24 months
Tegner Activity Score	The Tegner Activity Scale (TAS) is a simple, self-administered questionnaire that assesses a patient's level of activity, both at work and in sports, on a scale of 0 to 10The TAS is a 1-item questionnaire scored on a scale of 0 to 10. 0: represents maximum disability due to knee problems, such as being on sick leave or disability. 10: represents participation in competitive sports at a national or international elite level, like soccer.	Baseline and 3, 6, 12, and 24 months
Time to Return to Sport/Previous Activity Level	Time to Return to Sport/Previous Activity Level	Months 3, 6, 12, and 24
Y-Balance Distance	asked to reach a maximum distance in 3 different directions (shape of a "Y") - do this while standing on 1 leg and staying balanced. Both legs will be tested	Months 6, 12, and 24
Number of Single Hop	asked to perform a maximum single leg broad jump - 2 reps on each leg	Months 6, 12, and 24
Number of Triple Hops	asked to perform a single leg triple hop (hop forward 3 times in a row) - 2 reps on each leg	Months 6, 12, and 24
Biodex Strength Testing	measure the strength of your thigh muscles (quadriceps and hamstrings) - kick leg forward and pull leg backward as hard as possible - perform this assessment at 1 to 2 different speeds (the machine controls the speed). Both legs will be tested.	Months 6, 12, and 24
Reoperation Rate	Reoperation Rate	Months 3, 6, 12, and 24
Failure Rate	Failure Rate	Months 3, 6, 12, and 24
Brace Compliance Rate	While wearing the brace, the sensor will track how many hours the brace is in use. The goal of the sensor is to track compliance of wearing the brace during rehabilitative and sport (or military) specific activity.	Months 6, 12, and 24
Number of Brace Complications	Number of Brace Complications	Months 6, 12, and 24

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Brian Waterman, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Anterior Cruciate Ligament (ACL) reconstruction; postoperative bracing; functional bracing
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: IRB00123098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No