Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
Recruiting · NCT06893302 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital for Special Surgery, New York
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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
- Ages 18-64
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 it is running
1 location listed across 1 US state.
- Hospital for Special Surgery - New York, New York, United States