Actively Recruiting
Led by University of Arizona · Updated on 2025-05-16
75
Participants Needed
3
Research Sites
N/A
Total Duration
Researchers are evaluating two different bone graft options for patients undergoing bone patellar-tendon bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR). The study compares autologous bone grafts, which use the patient's own bone, with a commercially available Demineralized Bone Matrix (DBM) putty. The trial aims to assess differences in surgical time, complications, and clinical outcomes related to the patellar defect after ACL reconstruction. Participants will be randomly assigned to receive either autologous bone graft treatment or DBM putty during their ACL reconstruction surgery. DBM is a processed bone allograft that retains organic proteins and growth factors. Throughout the study, patients and researchers will evaluate recovery aspects such as pain, range of motion, radiographic changes, and infection rates. The study will monitor outcomes up to one year after the procedure. During the study, patients will report pain levels using a visual analog scale and complete functional tests like the Tegner-Lysholm and Cincinnati ACL Test before and after surgery. The principal investigator will assess both subjective experiences and objective measures such as knee motion and radiographic evidence of arthritis. The research team will track surgical time and complications related to the bone graft and patellar void filling. Participation will last at least one year for outcome follow-up.
CONDITIONS
Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of procedure
Participants undergo anterior cruciate ligament reconstruction using either autologous bone grafts or demineralized bone matrix to fill the patellar defect.
1 surgical visit (in-person)
Duration - 1 year post procedure
Participants are monitored for complications related to the bone graft and assessed for clinical outcomes following surgery.
Follow-up visits as scheduled during the year post-surgery
Total: 3 locations
1
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Banner Health Center Plus - Arcadia
Phoenix, Arizona, United States, 85008
Actively Recruiting
3
Banner Sports Medicine Scottsdale
Scottsdale, Arizona, United States, 85256
Actively Recruiting
M
Marleny Munoz
P
Phoenix Biomedical Campus Regulatory Team
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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