NCT04595890

Knee Injections for the Clinical Management of Knee OsteoArthritis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Delaware · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Knee osteoarthritis (OA) is an incurable disease that involves breakdown of the knee joint. This breakdown is often accompanied by knee pain and stiffness, which can limit a person's daily physical activity. Fortunately, there are treatments that may stop or slow the progression of knee OA. Bone marrow aspirate can be extracted and processed into autologous, nucleated cells, then injected back into the knee affected by OA. These cells provide important nutrients that can improve the health of the knee joint and alleviate the symptoms of knee OA. Therefore, the investigators are interested in determining whether an injection of autologous, nucleated cells can improve physical activity, pain and function in people who are diagnosed with knee OA. The investigators will recruit a total of 100 subjects for this study and examine changes in physical activity using a research-grade Actigraph Monitor.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC)	Participants will have bone marrow aspirated from their iliac crest, then processed using the Arthrex Angel System to produce autologous bone marrow concentrate (BMC). Then, BMC will be injected into the participant's knee with knee osteoarthritis (OA).
OTHER	Saline injection	Participants will have bone marrow aspirated from their iliac crest to maintain masking. Then, saline will be injected into the participant's knee with knee osteoarthritis (OA).

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2020-10-22
• Last updated: 2023-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study