NCT06975306

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Graft; Complications
• ACL Injuries

Interventions

Type	Name	Description
PROCEDURE	autologous bone grafts	group will be treated with autologous bone graft for BTB ACLR
OTHER	Demineralized bone matrix (DBM)	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.

Timeline

• Start date: 2025-02-11
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

3 sites across 1 country: United States