Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06942754
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Injuries

Eligibility Criteria

Sex
ALL
Age
14 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 11, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Katherine Leonard
[email protected]
336-716-3952

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By research site
Wake Forest University Health Sciences· Winston-Salem, NC

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