RECRUITING

Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-11
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06942754

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * patients with unilateral complete ACL injury
  2. * patients involved in sports and the desire to return to sports
  3. * patients undergoing quadriceps autograft ACL reconstruction
  4. * must be 14 to 39 years old
  1. * multiligamentous knee injuries defined as two ligaments requiring surgical stabilization
  2. * concomitant suture tape augmentation, extra-articular tenodesis or anterolateral ligament reconstruction
  3. * concomitant femoral, tibial, or patellar fracture(s)
  4. * patients with significant osteoarthritis
  5. * concomitant ipsilateral knee dislocation or patellar dislocation
  6. * significant lower leg malalignment requiring correcting osteotomies
  7. * prior ACL surgery, including contralateral knee
  8. * pregnancy during injury or surgery
  9. * unable to provide consent
  10. * prolonged use of prednisolone or cytostatics
  11. * comorbidities (e.g., muscular, neurological, vascular) that influence rehabilitation

Contacts and Locations

Study Contact

Katherine Leonard
CONTACT
336-716-3952
kmleonar@wakehealth.edu

Principal Investigator

Brian Waterman, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Brian Waterman, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-11
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-09-11
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Anterior Cruciate Ligament Injuries