Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
NCT06975306 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2025-05-16
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
- 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.
Sponsors & Collaborators
-
University of Arizona
lead OTHER
Principal Investigators
-
Anup Shah, MD · College of Medicine - Phoenix
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-11
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
Countries
- United States
Study Locations
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