NCT06975306 Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
| NCT ID | NCT06975306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Arizona |
| Condition | Bone Graft; Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2025-02-11 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Anup Shah, MD
PRINCIPAL INVESTIGATOR
College of Medicine - Phoenix
Frequently Asked Questions
Who can join the NCT06975306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Bone Graft; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06975306 currently recruiting?
Yes, NCT06975306 is actively recruiting participants. Contact the research team at marlenymunoz@arizona.edu for enrollment information.
Where is the NCT06975306 trial being conducted?
This trial is being conducted at Phoenix, United States, Phoenix, United States, Scottsdale, United States.
Who is sponsoring the NCT06975306 clinical trial?
NCT06975306 is sponsored by University of Arizona. The principal investigator is Anup Shah, MD at College of Medicine - Phoenix. The trial plans to enroll 75 participants.