RecruitingNot Applicable

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

United States75 participantsStarted 2025-02-11

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change in surgical time

Timeframe: Duration of Procedure

Change in number of complications from the coring reamer intra-operatively

Timeframe: Duration of Procedure

Change in number of complications associated with displacement of the bone graft

Timeframe: 1 year post procedure

Change in outcomes by immediately filling the patellar void following BTB graft harvest

Timeframe: 1 year post procedure

Change in outcomes by immediately filling the patellar void following BTB graft harvest

Timeframe: 1 year post procedure

Trial details

NCT IDNCT06975306

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Marleny Munoz

602-793-9582 marlenymunoz@arizona.edu

View on ClinicalTrials.gov More Bone Graft; Complications trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

change in surgical time

Timeframe: Duration of Procedure

Change in number of complications from the coring reamer intra-operatively

Timeframe: Duration of Procedure

Change in number of complications associated with displacement of the bone graft

Timeframe: 1 year post procedure

Change in outcomes by immediately filling the patellar void following BTB graft harvest

Timeframe: 1 year post procedure

Change in outcomes by immediately filling the patellar void following BTB graft harvest

Timeframe: 1 year post procedure