About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Bone Marrow Aspirate (BMA)
Biological/VaccineBone 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
Procedure/SurgeryArthroscopic debridement surgery of the knee is performed to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.
Saline
Other interventionPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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