Clinical Trial

Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction

Study acronym: BTB BackFill
Recruiting
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Summary
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05-31 -> 2027-04-30 2026-08-15
minor Completion pushed: 2026-05-31 -> 2027-04-30 2026-08-15
Trial Details
NCT Number NCT06975306
Lead Sponsor University of Arizona
Conditions Bone Graft; Complications, ACL Injuries
Enrollment 75 participants
Start Date 2025-02-11
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-14