Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace

Part of paid clinical trials in Huntington, West Virginia.

Sponsor
Marshall University
Study ID
NCT06294314
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Rupture

Eligibility Criteria

Sex
ALL
Age
14 Years - 26 Years
Healthy Volunteers
Accepted

Interventions

  • Fertilized ACL — PROCEDURE
    Fertilized ACL is an acl reconstruction with Bone marrow aspirate, demineralized bone matrix, and an internal brace.

Study Details

The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.

Key Dates

Start date
Feb 26, 2024
Status verified
Feb 2024
Primary completion
Aug 1, 2026
Completion
Jul 1, 2028

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: Treatment
    These patients receive the surgery and are followed for two years for outcomes.
  • Arm: Control
    These patients do not need and don't receive surgery and are followed for two years to compare to the surgery treatment group

Primary Outcome Measure

Return to play [ Time Frame: 6 months after surgery until study conclusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Marshall UniversityHuntingtonWest Virginia25755
chad d lavender, md
[email protected]
304-552-6514
Kara Cipriani, np
[email protected]
304-541-5316

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By research site
Marshall University· Huntington, WV

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