Bone Marrow Aspirate for Knee Injuries
(BMA Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAnil S Ranawat, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hospital for Special Surgery, New York

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will examine whether using bone marrow aspirate (BMA) during knee arthroscopy surgery can improve patient outcomes. The investigators will enroll 50 patients who need knee arthroscopy surgery for meniscus injuries or cartilage damage. Like flipping a coin, patients will be randomly assigned to one of two groups of 25 patients each. One group will receive standard arthroscopic surgery plus an injection of bone marrow aspirate, while the other group will receive standard surgery plus a saline (salt water) injection. During surgery, for patients in the treatment group, approximately 4mL (less than one teaspoon) of bone marrow will be taken from their hip bone using a special needle system. A small amount (1mL) will be sent to the laboratory for testing. Patients will be followed for 12 months after surgery and will complete questionnaires about their pain levels and knee function at several time points: before surgery, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. These questionnaires will ask about pain, daily activities, and overall improvement.

Research Team

Anil S Ranawat, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

This trial is for individuals aged 18-55 with mild knee arthritis or cartilage damage who need primary knee arthroscopy. Candidates should not have had previous knee surgery, metabolic bone diseases, recent OrthoBiologics treatments, ligament deficiencies, severe arthritis, anemia, bleeding disorders or inflammatory joint disease.

Inclusion Criteria

My arthritis is at the earliest stage according to Kellgren-Lawrence grading.

I am between 18 and 55 years old.

Have Outerbridge cartilage grade 2 or lower

See 1 more

Exclusion Criteria

I have had surgery on the same knee before.

I have a history of bone disease such as osteoporosis or Paget's disease.

I have not used any OrthoBiologics within 6 months before surgery.

See 8 more

Treatment Details

Interventions

Bone Marrow Aspirate (BMA) (Stem Cell Therapy)

Trial OverviewThe study tests if injecting Bone Marrow Aspirate (BMA) during knee arthroscopy improves outcomes compared to a saline injection. Participants are randomly divided into two groups: one receives BMA and the other saline alongside standard surgery. They're monitored for a year post-surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arthroscopic Debridement Surgery + Bone Marrow Aspirate (BMA)Experimental Treatment2 Interventions

Arthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study. The study investigates the effect of combining the standard of care with a bone marrow aspirate (BMA), therefore this serves as the Active Experimental arm.

Group II: Arthroscopic Debridement Surgery + SalineActive Control2 Interventions

Arthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study, therefore it serves as an Active Comparator to the experimental arm which is the same procedure but with the addition of bone marrow aspirate (BMA) injection.