Adding bone marrow aspirate to knee arthroscopy for meniscus and cartilage injuries
Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial
This trial will test whether giving a small bone marrow aspirate injection during knee arthroscopy helps adults (18–64) with meniscal tears or focal cartilage damage have less pain and better knee function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06893302 on ClinicalTrials.gov |
What this trial studies
Fifty adults undergoing primary knee arthroscopy for meniscal injury or focal cartilage defects will be randomly assigned 1:1 to receive either standard arthroscopic debridement plus an intraoperative bone marrow aspirate (approximately 4 mL obtained from the ilium with the Marrow Cellution system) or standard surgery plus a saline injection. One milliliter of aspirate will be sent for laboratory testing, and surgery recipients and outcomes will be followed for 12 months. Patient-reported pain and knee function questionnaires will be completed before surgery and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. The trial compares clinical outcomes and reports BMA cell counts against previously published bone marrow concentrate (BMAC) values, but does not process or evaluate BMAC.
Who should consider this trial
Good fit: Adults aged 18–64 who need primary knee arthroscopy for a meniscal tear or focal chondral defect, with Kellgren-Lawrence grade 0 and Outerbridge cartilage grade 2 or lower, who have not had prior ipsilateral knee surgery and meet other listed medical criteria are ideal candidates.
Not a fit: Patients with advanced osteoarthritis (Kellgren-Lawrence ≥3), inflammatory or metabolic bone disease, prior ipsilateral knee surgery, ligament deficiencies, those needing meniscal repair or realignment procedures, or pregnant patients are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, adding BMA could reduce pain and improve knee function after arthroscopy while potentially saving time and cost by avoiding centrifugation steps used for concentrated products.
How similar studies have performed: There is a paucity of high-quality randomized evidence for BMA in knee arthroscopy, with only preliminary and small studies suggesting potential benefit, so this approach remains largely untested in rigorous trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Require a primary knee arthroscopy for a meniscal injury or focal chondral defect (knee debridement or meniscectomy) 2. Have Kellgren-Lawrence grade 0 arthritis 3. Have Outerbridge cartilage grade 2 or lower 4. Ages 18-64 Exclusion Criteria: 1. Have previously undergone ipsilateral knee surgery 2. Have Kellegren-Lawrence grade 3 or greater 3. Have received other OrthoBiologics within 3 mo of surgery 4. Have ligament deficiencies 5. Need meniscal repair 6. Need a concomitant osteotomy or other realignment surgery 7. Have used DMARDs within the last three months 8. Have a hx of anemia, bleeding disorders, or inflammatory joint disease (rheumatoid arthritis, infectious arthritis, hemophilic arthropathy, Charcot's knee) 9. Have a hx of metabolic bone disease (osteoporosis, osteomalacia, rickets, osteitis fibrosa cystica, Paget's disease of bone) 10. Patients who are currently pregnant
Where this trial is running
New York, New York
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Anil S Ranawat, MD — Hospital for Special Surgery, New York
- Study coordinator: Akshay K Raghuram
- Email: raghurama@hss.edu
- Phone: (646) 714-6067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.