Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
BMA
Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2025
CompletedFirst Posted
Study publicly available on registry
March 25, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
Study Completion
Last participant's last visit for all outcomes
April 1, 2029
April 27, 2026
March 1, 2026
1.8 years
March 18, 2025
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcomes Score (KOOS) 0-100 score range, with 0 representing extreme knee problems and 100 representing no knee problems.
12 month follow-up
Study Arms (2)
Arthroscopic Debridement Surgery + Saline
ACTIVE COMPARATORArthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study, therefore it serves as an Active Comparator to the experimental arm which is the same procedure but with the addition of bone marrow aspirate (BMA) injection.
Arthroscopic Debridement Surgery + Bone Marrow Aspirate (BMA)
EXPERIMENTALArthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study. The study investigates the effect of combining the standard of care with a bone marrow aspirate (BMA), therefore this serves as the Active Experimental arm.
Interventions
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 of the knee is performed to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anil S Ranawat, MD
Hospital for Special Surgery, New York
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2025
First Posted
March 25, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2029
Last Updated
April 27, 2026
Record last verified: 2026-03