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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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.
Mayo Clinic in Florida
Jacksonville, Florida, United States
Adverse Reactions
Occurrence of adverse reactions to BMAC when delivered after shoulder CAM procedure
Time frame: 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
Time frame: 1-3 Weeks Post-Procedure
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).
Time frame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
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.
Time frame: 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%.
Time frame: 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
Time frame: Screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 12 Months