Bone Grafting for Anterior Cruciate Ligament Injury

(BTB BackFill Trial)

Recruiting at 2 trial locations

Overseen By Phoenix Biomedical Campus Regulatory Team

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Age, Prior ACLR, Non-compliance, Nicotine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate post-operative period

75 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anup Shah, MD

Principal Investigator

College of Medicine - Phoenix

Eligibility Criteria

This trial is for individuals with an Anterior Cruciate Ligament (ACL) injury who are undergoing reconstruction and can provide informed consent. Specific eligibility criteria are not provided, but typically participants must be in good health aside from their ACL injury.

Inclusion Criteria

Compliant post-operative course

All races not including vulnerable/special consideration populations

I identify as male, female, or gender neutral.

Exclusion Criteria

Nicotine dependence

Non-compliance post-operatively

I had ACL reconstruction using a bone-patellar tendon-bone graft.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACL reconstruction surgery with either autologous bone graft or DBM putty

Surgery and immediate post-operative period

Follow-up

Participants are monitored for clinical outcomes, including pain, range of motion, and radiographic changes

1 year

Treatment Details

Interventions

• Autologous Bone Graft
• Demineralized Bone Matrix (DBM)

Trial Overview The study compares two methods of filling the patellar defect after ACL surgery: one uses the patient's own bone graft, while the other uses a DBM putty. Patients at Banner University will be randomly assigned to either group and won't know which treatment they received until after the study ends.

Participant Groups

Group I: autologous bone graft Experimental Treatment 1 Intervention

One group will be treated with autologous bone graft for BTB ACLR

Group II: Demineralized bone matrix (DBM) putty Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+