Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorHospital for Special Surgery, New York

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Bone Marrow Aspirate (BMA)

    Biological/Vaccine

    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

    Procedure/Surgery

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

  • Saline

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arthroscopic Debridement Surgery + SalineActive comparator 2 interventions
Group B: Arthroscopic Debridement Surgery + Bone Marrow Aspirate (BMA)Experimental treatment 2 interventions

Trial outcomes

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.

Time frame
12 month follow-up

Secondary outcomes

Other outcomes

Sponsors and contacts

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