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All patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. Patients will not be advised which group they belong to until after the completion of the study. One group will be treated with autologous bone graft for bone patellar-tendon bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR), and the other group will be treated with commercially available DBM (Demineralized bone matrix) putty. Patients will be enrolled from Banner University. Before and after surgery, patient reported outcomes including visual analog pain scale (VAS), Tegner-Lysholm and Cincinnati ACL Test. The principal investigator will evaluate the patients on subjective criteria such as pain and objective criteria including range of motion, arthritic changes seen on radiographs, infection, and ability to kneel.
Age
18 - 40 years
Sex
ALL
Healthy Volunteers
No
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Banner Health Center Plus - Arcadia
Phoenix, Arizona, United States
Banner Sports Medicine Scottsdale
Scottsdale, Arizona, United States
Start Date
February 11, 2025
Primary Completion Date
May 31, 2026
Completion Date
May 31, 2026
Last Updated
May 16, 2025
75
ESTIMATED participants
autologous bone grafts
PROCEDURE
Demineralized bone matrix (DBM)
OTHER
Lead Sponsor
University of Arizona
NCT06748066
NCT07049484
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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