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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Banner Health Center Plus - Arcadia
RECRUITING
Phoenix
Banner University Medical Center Phoenix
RECRUITING
Phoenix
Banner Sports Medicine Scottsdale
RECRUITING
Scottsdale
Contact Information
Primary
Marleny Munoz
marlenymunoz@arizona.edu
602-793-9582
Backup
Phoenix Biomedical Campus Regulatory Team
mlburchfi@arizona.edu
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 75
Treatments
Experimental: autologous bone graft
One group will be treated with autologous bone graft for BTB ACLR
Experimental: Demineralized bone matrix (DBM) putty
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.
Related Therapeutic Areas
Sponsors
Leads: University of Arizona

This content was sourced from clinicaltrials.gov