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RECRUITING Not applicable ClinicalTrials.gov

Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy

Sponsor: Hospital for Special Surgery, New York • ClinicalTrials.gov ID: NCT06893302

Registry updated: 2026-09-02
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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

  • Bone Marrow Aspirate (BMA) (Biological)
    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.
  • Arthroscopic Debridement Surgery (Procedure)
    Arthroscopic debridement surgery of the knee is performed to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.
  • Saline (Other)
    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.

Eligibility 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

Conditions

Chondral Lesion of the Knee Meniscal Injuries Cartilage Defects of the Knee Osteoarthritis (OA) of the Knee

Locations

  • Hospital for Special Surgery — New York, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record