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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for individuals requiring surgery for an anterior cruciate ligament (ACL) injury. One group will receive an autologous bone graft, using the patient's own bone, while the other group will receive treatment with demineralized bone matrix (DBM) putty. Researchers will assess pain levels, range of motion, and healing outcomes. The trial is open to individuals aged 18 to 40 who are candidates for ACL surgery and can adhere to post-surgery instructions. As an unphased trial, this study offers an opportunity to contribute to medical knowledge and potentially benefit from innovative treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a patient's own bone for ACL (anterior cruciate ligament) surgery can lead to varying results. Some individuals experience good to excellent outcomes, but there is a risk of knee pain after surgery. This pain can range from mild to more noticeable, particularly when kneeling.

Studies indicate that demineralized bone matrix (DBM) putty aids in bone healing during ACL surgeries, with no major issues reported. Made from processed bone tissue, DBM putty contains essential proteins and growth factors that support healing.

Both treatments have been applied in various situations. While reports of pain exist with using one's own bone, DBM putty is generally considered safe. However, results can vary among individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for anterior cruciate ligament (ACL) injuries because they offer innovative approaches to bone grafting. Unlike traditional methods that often use synthetic materials or bone from donors, the autologous bone graft involves using the patient's own bone, potentially reducing the risk of rejection and infection. Meanwhile, the Demineralized Bone Matrix (DBM) putty is unique as it retains essential proteins and growth factors from bone tissue, which might enhance healing and integration. These treatments are paving the way for more personalized and biologically integrated solutions for ACL reconstruction.

What evidence suggests that this trial's treatments could be effective for ACL injury?

This trial will compare two treatments for ACL reconstruction: autologous bone grafts and demineralized bone matrix (DBM). Studies have shown that autologous bone grafts can lead to good to excellent results for many patients, with satisfactory outcomes in up to 85% of cases, helping restore knee stability and function after an ACL injury. Meanwhile, DBM has been found to improve bone healing in ACL surgery, which is crucial for recovery. Initial findings suggest it supports bone regrowth where the ligament attaches. Both treatments have their strengths, and current research supports their use in improving outcomes for those undergoing ACL reconstruction. ^{1 2 4 6 7}

Who Is on the Research Team?

Anup Shah, MD

Principal Investigator

College of Medicine - Phoenix

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3438864/

Clinical Outcomes After Anterior Cruciate Ligament ... Clinical outcomes of autograft and allograft anterior cruciate ligament (ACL) reconstructions are mixed, with some reports of excellent to good outcomes.

2. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/143767

What are the Graft Options for Anterior Cruciate Ligament ... While older studies have reported satisfactory outcomes in up to 85*%* of cases, these findings are based on a small cohort, and there is a ...

3. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2024.1444465/full

A comparative analysis of autograft choices of anterior ... Results: Significant differences in QPT and HPT recovery between the healthy and injured legs were found in all graft groups (P < 0.001). The ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X20300493

Comparative Efficacy of Graft Options in Anterior Cruciate ... Conclusion. This study suggests that PT-AU may be the most appropriate graft for ACL reconstruction according to IKDC and Lachman test results.

5. journals.lww.com journals.lww.com/md-journal/fulltext/2020/10230/comparison_of_the_effectiveness_of_autologous.86.aspx

Comparison of the effectiveness of autologous grafts for... This study evaluated the published systematic reviews on the efficacy of different autologous ligament grafts in ACLR, and based on this, conducted a network ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X24000208

Systematic Review Following Anterior Cruciate Ligament ... The incidences of anterior knee pain and kneeling pain following ACLR with BPTB autograft range from 5.4% to 48.4% and 4.0% to 75.6%, respectively.

7. sportsmed.org sportsmed.org/membership/sports-medicine-update/spring-2024/evolving-concepts-in-acl-surgery

Evolving Concepts in Anterior Cruciate Ligament Surgery Furthermore, QT autografts have demonstrated comparable patient-reported outcomes including International Knee Documentation Committee (IKDC) and Knee Injury ...