Clinical trial NCT06893302: Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
Official title: Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chondral Lesion of the Knee
Meniscal Injuries
Cartilage Defects of the Knee
Osteoarthritis (OA) of the Knee
Keywords: knee arthroscopy
meniscal injury
knee debridement
meniscectomy
osteoarthritis
cartilage defect
chondral lesion
bone marrow aspirate
BMA
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to receive arthroscopic debridement surgery with saline injection or arthroscopic debridement surgery supplemented with bone marrow aspirate (BMA) injection.
Primary purpose: TREATMENT

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.

Detailed 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, CD40, 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 outcomes from knee arthroscopy. If this is true, this study could expand the reach of Cervos' BMA, improving the field of knee arthroscopy surgery and helping push orthopedics forward. Additionally, it could save surgeons and lab technicians time, and hospital's money, by removing the centrifugation step required in bone marrow concentrate products. Alternatively, no effect could help save patients money and help surgeons avoid this unnecessary treatment.

A total of 50 patients with osteoarthritis of the knee will be randomly assigned to receive arthroscopic debridement surgery or arthroscopic debridement surgery supplemented with bone marrow aspirate (BMA). Approximately 4mL of BMA will be obtained from different areas of the ilium using the Marrow Cellution™ aspiration system (Ranfac Corp., Avon, MA) following the manufacturer's instructions (Ranfac Technique Guide) intraoperatively for the patients in the treatment group. 1 mL of this will be set aside and sent to the lab for CBC, CD40 and CFU counts for comparison with other bone marrow aspirate products. Patients were randomized in equal numbers into either the treatment or control group (25 in each group). Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 12-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. The following measures will be included: IKDC, VAS, WOMAC, MARX, and PGIC will be collected at time points of baseline, 2 weeks, 6 weeks, and 3 months, 6 months, and 12 months.

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 18-55

Exclusion Criteria:

1. Have previously undergone ipsilateral knee surgery
2. Have Kellegren-Lawrence grade 3 or greater
3. Have received other OrthoBiologics within 6 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. Have had a prior steroid injection
11. Patients who are currently pregnant

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Anil S Ranawat, MD
role: PRINCIPAL_INVESTIGATOR
References: