Skip to main content
Bone Graft; ComplicationsBones and jointsProcedure

What this study is

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.

What's being tested

  • autologous bone grafts

    Intervention · PROCEDURE

    group will be treated with autologous bone graft for BTB ACLR

  • Demineralized bone matrix (DBM)

    Intervention · OTHER

    Demineralized bone matrix (DBM) is a biologic allograft product derived from bone tissue that has undergone a process of demineralization to remove inorganic mineral components while retaining the organic matrix, including proteins and growth factors.

Study details

Sponsor
University of Arizona
Conditions
Bone Graft; Complications · ACL Injuries
Enrolling
75 people
Starts
2025-02-11
Est. completion
2027-04-30
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗