NCT06975306 · University of Arizona
Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction
(BTB BackFill)
What this study is about
All patients will be randomly assigned using a computer randomization algorithm to one of two matched group of participants groups. Patients will not be advised which group they belong to until after the completion of the study.
View original scientific description
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.
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.
Primary outcome measures
change in surgical time
Time frame: Duration of Procedure
Change in number of complications from the coring reamer intra-operatively
Time frame: Duration of Procedure
Change in number of complications associated with displacement of the bone graft
Time frame: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest
Time frame: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Tegner-Lysholm Knee Scoring Scale
Change in outcomes by immediately filling the patellar void following BTB graft harvest
Time frame: 1 year post procedure
Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Cincinnati Knee Rating System
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Phoenix, Arizona
- Scottsdale, Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 16, 2025 · Source of record for eligibility and locations