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FDA upregulation of dCPC.
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To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.
To compare the functional outcomes in patients undergoing treatment of knee osteoarthritis using cortisone steroid injections (CSI) or a dehydrated cell and protein concentrate (dCPC) product, Ascent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascent Intervention Treatment | Experimental | Interventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection |
|
| Standard Treatment | Active Comparator | Standard treatment arm will receive a standard Corticosteroid injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascent | Procedure | Dehydrated Cell and Protein Concentrate injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring changes in quality of life due to treatment, as assessed by patient reported survey. | The Quality of Life Survey is a patient-reported outcome measure divided into two parts. The first part of the Quality of Life questionnaire/survey will include 4 questions in which patients will be asked to evaluate their individual levels of knee problems (knee difficulty, knee confidence, and lifestyle modifications). Answers will be reported on a 5 point likert scale, in which higher scores indicate more severity, and lower scores indicate less severity. The second part of the questionnaire will include 6 categories (discomfort, mobility, self-care, anxiety, performance of activities, and sleeping). There will be 3 statements per category in which the patient is asked to indicate which statement best describes their current health. The questionnaire is scored by adding up the scores of each item to compute a total score. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measured change in pain: VAS | The Visual Analog scale is a patient-reported outcome measure. It will be presented numerically as an 11 point scale that will ask the patient to rate the severity of their pain on a scale form 0 to 10, which 10 being the most pain imaginable and 0 being the least (no pain). The numerical value will be reported based on the patient's response. The mean pain scores of each intervention group will be calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oluseun Olufade, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Sports Medicine Complex | Brookhaven | Georgia | 30329 | United States | ||
| Emory At Dunwoody |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35586982 | Derived | Olufade O, Negron G, Berrigan W, Sirutis B, Whitley J, Easley K, Chen Y, Mautner K. Amniotic dehydrated cell and protein concentrate versus corticosteroid in knee osteoarthritis: preliminary findings. Regen Med. 2022 Jul;17(7):431-443. doi: 10.2217/rme-2022-0005. Epub 2022 May 19. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Standard |
| Procedure |
Standard corticosteroid injection |
|
| 12 months |
| Dunwoody |
| Georgia |
| 30338 |
| United States |
| Emory Orthopaedics and Spine Center | Johns Creek | Georgia | 30097 | United States |
| Emory at Smyrna | Smyrna | Georgia | 30080 | United States |
| D012216 |
| Rheumatic Diseases |