RecruitingNot ApplicableNCT06893302

Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy

Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial

Sponsor

Hospital for Special Surgery, New York

Enrollment

50 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria4

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 Criteria10

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

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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.