Not provided
Not provided
Not provided
Not provided
Discontinued funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Injection of Bone Marrow Concentrate (BMC) |
|
| Control Group | Placebo Comparator | Injection of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | 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. | Change in physical activity from baseline to 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain of Target Knee | The investigators will ask participants to complete the Visual Analog Scale (VAS), a single-item instrument in which the participant makes a mark on a 100 mm line to indicate their pain score in each knee from 0-100. A higher score indicates greater pain intensity of the target knee. The instrument takes <1 minute to complete. | Change in pain of target knee from baseline to 3 weeks, and change in pain of target knee from baseline to 3 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Related to knee OA diagnosis:
Related to current health status or medical history:
Findings on clinical examination that preclude safe participation in the study, including (but not limited to):
Non-ambulatory (e.g., use a manual or power wheelchair)
Diagnosis of rheumatoid arthritis, inflammatory arthritis, or gout
Uncontrolled diabetes (e.g., glycosylated hemoglobin level >7.0)
Known contraindications to MRI, including: heart pacemaker, artificial heart valves, metal implants such as metal ear implants, bullet pieces, chemotherapy or insulin pumps, metal clips or rings
Body mass index > 40 kg/m 2
Increased risk for postsurgical bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin)
Increased risk for postsurgical infection (e.g., taking immunosuppressants, having a severe infection, or a having a history of serious infection)
Known allergy to lidocaine or other anesthetics
History of anemia
Recent infection of target knee (within last month) requiring antibiotics
History of bone marrow harvest or biopsy at any time
Active malignancy or history of bone marrow malignancy
Related to previous OA management:
Related to other personal factors:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel K White, PT, ScD, MSc | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19713 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Saline injection | Other | 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). |
|
| Function of Target Knee | The investigators will ask participants to complete the Knee Injury and Osteoarthritis Outcome Score (KOOS), a 42-item instrument that assesses the following five domains: pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The score is a percentage score from 0 to 100, 0 representing extreme problems of the target knee and 100 representing no problems of the target knee. The instrument takes approximately 10 minutes to complete. | Change in function of target knee from baseline to 3 weeks, and change in function of target knee from baseline to 3 months. |
| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |
| D017670 |
| Sodium Compounds |