Bone Marrow Aspirate for ACL Injuries

Phase 4

Recruiting

Led By Miguel Otero, Ph.D.

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 6 months, 12 months and 24 months post-operative

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to study the effectiveness of concentrated bone marrow aspirate (cBMA) in reducing symptoms of post traumatic osteoarthritis (PTOA) in patients having revision anterior cruciate lig

Who is the study for?

This trial is for individuals who have had a previous ACL (Anterior Cruciate Ligament) reconstruction and are now in need of a revision surgery. They should be experiencing symptoms related to post-traumatic osteoarthritis. Specific eligibility criteria details were not provided.

What is being tested?

The study is testing the effectiveness of concentrated bone marrow aspirate (cBMA) injections during revision ACL surgery, compared to standard care with sham incision. It aims to see if cBMA can reduce pain and inflammation markers after surgery.

What are the potential side effects?

Potential side effects were not detailed, but may include typical risks associated with surgical procedures such as infection, bleeding, or reactions at the injection site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 6 months, 12 months and 24 months post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 6 months, 12 months and 24 months post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 6 months, 12 months and 24 months post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in patient reported knee pain

Secondary study objectives

Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization

Change from baseline in cartilage morphology

Concentration of circulating inflammatory biomarkers

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Investigational ArmExperimental Treatment2 Interventions

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).

Group II: Control ArmPlacebo Group2 Interventions

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting.

Do I qualify?Apply below to find out