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

Not Applicable

Recruiting

• Conditions: Bone Graft; Complications; ACL Injuries

• Registration Number: NCT06975306
• Lead Sponsor: University of Arizona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-11
• Study First Submitted: 2025-04-21
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 18-40 years old,
• male/female/gender neutral,
• all races not including vulnerable/special consideration populations,
• candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft,
• compliant post operative course.

Exclusion Criteria

• < 18, >41 years of age,
• prior bone patellar bone anterior cruciate ligament reconstruction,
• non-compliance post-operatively,
• nicotine dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in surgical time	Duration of Procedure
Change in number of complications from the coring reamer intra-operatively	Duration of Procedure
Change in number of complications associated with displacement of the bone graft	1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest	1 year post procedure	Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Cincinnati Knee Rating System

Trial Locations

Locations (3)

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