Knee Injections for the Clinical Management of Knee OsteoArthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- University of Delaware
- Locations
- 1
- Primary Endpoint
- Physical Activity
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults 40-79 years of age
- •Doctor-diagnosed knee OA
Exclusion Criteria
- •Related to knee OA diagnosis:
- •Seeking treatment for end-stage knee OA (Kellgren-Lawrence Grade 4 on X-ray)
- •Seeking advanced treatment options for knee OA (e.g., knee replacement) within 6 months
- •Seeking treatment for bilateral symptomatic knee OA
- •Related to current health status or medical history:
- •Findings on clinical examination that preclude safe participation in the study, including (but not limited to):
- •3+ effusion of the target knee
- •Significant varus or valgus alignment deformity
- •Non-ambulatory (e.g., use a manual or power wheelchair)
- •Diagnosis of rheumatoid arthritis, inflammatory arthritis, or gout
Outcomes
Primary Outcomes
Physical Activity
Time Frame: Change in physical activity from baseline to 3 months.
The investigators will use the Actigraph GT3X (Actigraph LLC, Pensacola, FL) to objectively measure physical activity. The Actigraph GT3X is a hip-worn accelerometer that measures the intensity of physical activity on a minute-by-minute basis. The Actigraph GT3X is valid and reliable in community-dwelling older adults with knee OA.
Secondary Outcomes
- Pain of Target Knee(Change in pain of target knee from baseline to 3 weeks, and change in pain of target knee from baseline to 3 months.)
- Function of Target Knee(Change in function of target knee from baseline to 3 weeks, and change in function of target knee from baseline to 3 months.)