NCT06893302 · Hospital for Special Surgery, New York
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
(BMA)
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
Bone Marrow Aspirate (BMA)
Bone marrow aspirate (BMA) is being investigated as an augmentation to arthroscopic debridement surgery of the knee to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.
PROCEDURE
Arthroscopic Debridement Surgery
Arthroscopic debridement surgery of the knee is performed to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.
OTHER
Saline
Patients in the control arm of the study will receive arthroscopic debridement surgery along with a saline injection. This will be compared to the experimental arm, in which patients will receive arthroscopic debridement surgery along with a bone marrow aspirate injection.
Primary outcome measures
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 month follow-up
Knee Injury and Osteoarthritis Outcomes Score (KOOS) 0-100 score range, with 0 representing extreme knee problems and 100 representing no knee problems.
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
- Require a primary knee arthroscopy for a meniscal injury or focal chondral defect (knee debridement or meniscectomy)
- Have Kellgren-Lawrence grade 0 arthritis
- Have Outerbridge cartilage grade 2 or lower
Exclusion criteria
- Have previously undergone ipsilateral knee surgery
- Have Kellegren-Lawrence grade 3 or greater
- Have received other OrthoBiologics within 3 mo of surgery
- Have ligament deficiencies
- Need meniscal repair
- Need a concomitant osteotomy or other realignment surgery
- Have used DMARDs within the last three months
- Have a hx of anemia, bleeding disorders, or inflammatory joint disease (rheumatoid arthritis, infectious arthritis, hemophilic arthropathy, Charcot's knee)
- Have a hx of metabolic bone disease (osteoporosis, osteomalacia, rickets, osteitis fibrosa cystica, Paget's disease of bone)
- Patients who are currently pregnant
Where
- New York, New York
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 Apr 27, 2026 · Source of record for eligibility and locations