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Search / Trial NCT06893302

Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Mar 18, 2025

Trial Information

Current as of April 22, 2025

Not yet recruiting

Keywords

Knee Arthroscopy Meniscal Injury Knee Debridement Meniscectomy Osteoarthritis Cartilage Defect Chondral Lesion Bone Marrow Aspirate Bma

ClinConnect Summary

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 reporte...

Gender

ALL

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

Trial Officials

Anil S Ranawat, MD

Principal Investigator

Hospital for Special Surgery, New York

About Hospital For Special Surgery, New York

The Hospital for Special Surgery (HSS) in New York is a world-renowned institution specializing in orthopedic surgery, rheumatology, and rehabilitation. Recognized for its commitment to advancing medical research and improving patient outcomes, HSS serves as a leading clinical trial sponsor, facilitating innovative studies that explore cutting-edge treatments and therapies. With a team of expert clinicians and researchers, HSS aims to enhance clinical practices through rigorous scientific inquiry, ultimately contributing to the advancement of musculoskeletal health and patient care on a global scale.

Locations

New York, New York, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported