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Lack of enrollment and funding for study.
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Researchers want to find out more about the side effects of Bone Marrow Aspirate Concentrate (BMAC) and what doses of BMAC are safe for people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Osteoarthritis of the shoulders | Experimental | Subjects diagnosed with Osteoarthritis of the shoulders will be injected with concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. | Biological | Bone marrow aspirate concentrate contains a median nucleated cell count of 121,700/uL, and platelets of 384,000/uL. This leads to a cellular dose of approximately 400 million cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Reactions | Occurrence of adverse reactions to BMAC when delivered after shoulder CAM procedure | 1-3 Weeks Post-Procedure |
| Morbidity related to bone marrow aspirations from iliac crests | Occurrence of adverse reactions to bone marrow aspirations from iliac crests | 1-3 Weeks Post-Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale (VAS) | Measured using the VAS questionnaire: a validated, subjective measure for pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10). | Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Schoch, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Change in American Shoulder and Elbow Surgeons Shoulder Score (ASES) | Measured using the self-reported ASES questionnaire that combines pain and activities of daily living (ADL) scores for a total score out of 100, where a higher score indicates a better outcome. | Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery. |
| Change in Subjective Shoulder Value | Subjective Shoulder Value (SSV) is a single-item self-completed measure in which patients are asked to grade their shoulder as a percentage of an entirely normal shoulder, which would score 100%. | Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery |
| Change in range of motion | Measured in degrees | Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery |
| To collect and explore pre and post injection measures of cartilage status in the affected shoulder. | Assessment of structural changes of the shoulder on conventional radiographs including measurement of inferior humeral osteophyte and joint space width | 12 Months |