Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial
Hospital for Special Surgery, New York
Summary
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.
Description
There is a paucity of high-quality literature surrounding the efficacy of BMA in knee arthroscopy, and this study will help to fill this gap. The investigators can obtain preliminary data that indicates the effect of BMA on patient reported outcomes and also help identify evaluation end points for future BMA randomized trials. Additionally, this study will allow us to see how CFU, CD140, and CBC counts compare between BMA and BMAC. Our study will not be evaluating BMAC, just comparing the BMA numbers to previously reported BMAC counts. Cervos' BMA product could offer improved patient reported…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalBone 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.
- ProcedureArthroscopic Debridement Surgery
Arthroscopic debridement surgery of the knee is performed to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.
- OtherSaline
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.
Location
- Hospital for Special SurgeryNew York, New York