Recruiting

Bone Marrow Aspirate

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT06893302

Conditions

Chondral Lesion of the Knee

Meniscal Injuries

Cartilage Defects of the Knee

Osteoarthritis (OA) of the Knee

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Bone Marrow Aspirate (BMA)

Arthroscopic Debridement Surgery

Saline

Study Details

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.

Conditions

Chondral Lesion of the Knee

Meniscal Injuries

Cartilage Defects of the Knee

Osteoarthritis (OA) of the Knee

Study ID

NCT06893302

Start date

Feb 3, 2026

Status verified date

Mar, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arthroscopic Debridement Surgery + Saline

Arthroscopic 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.

experimental: Arthroscopic Debridement Surgery + Bone Marrow Aspirate (BMA)

Arthroscopic 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)

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

Arthroscopic debridement surgery of the knee is performed to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.

Saline

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.

Primary outcome measure

  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 12 month follow-up ]

Central Contacts and Locations

Central contacts

Akshay K Raghuram

(646) 714-6067raghurama@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Sep 2, 2026

Last verified

Mar, 2026

Keywords

  • knee arthroscopy
  • meniscal injury
  • knee debridement
  • meniscectomy
  • osteoarthritis
  • cartilage defect
  • chondral lesion
  • bone marrow aspirate
  • BMA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-09-02.