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This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.
This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the shoulder. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room.
To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of the shoulder (glenohumeral joint). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MFAT (Micro Fragmented Adipose Tissue) | Experimental | Intra-articular shoulder injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's shoulder. |
|
| Conventional Therapy | Active Comparator | Intra-articular injection of corticosteroid (Triamcinolone 40mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micro Fragmented Adipose Tissue | Biological | Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| ASES Shoulder Score | Patient reported outcome measure that reports shoulder pain and shoulder functionality | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| DASH Outcome Measure | Patient reported questionnaire that measures physical function and symptoms | 24 Months |
| Veterans RAND 12 (VR-12) score | Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
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| Corticosteroid injection | Biological | Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid. |
|
| 24 Months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |