Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy

Official title

Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial

Overview

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, CD140, 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, CD140 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.

Interventions

• Biological 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.
• Procedure Arthroscopic Debridement Surgery
  Arthroscopic debridement surgery of the knee is performed to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.
• Other 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 measures

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• Need meniscal repair
• Need a concomitant osteotomy or other realignment surgery
• Have used DMARDs within the last three months
• Have a hx of anemia, bleeding disorders, or inflammatory joint disease (rheumatoid arthritis, infectious arthritis, hemophilic arthropathy, Charcot's knee)
• Have a hx of metabolic bone disease (osteoporosis, osteomalacia, rickets, osteitis fibrosa cystica, Paget's disease of bone)
• Patients who are currently pregnant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Hospital for Special Surgery — New York

Identifiers

NCT: NCT06893302 · 2023-2344

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗