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This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm A | Other | Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space |
|
| Control Arm B | Other | Subjects will receive one injection of Corticosteroid in the lateral epicondyle space |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Human Platelet Lysate | Biological | Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Score (VAS) | Day 0, Month 1, Month 2, End of Study - Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3 | Day 0, End of study - Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient rated tennis elbow evaluation (PRTEE Score) | Day 0, Month 1, Month 2, End of study-Month 3 | |
| The American Shoulder and Elbow Society score | Dya 0, Month 1, Month 2, End of study-Month 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaushal Shah, Phd | Contact | +91-22-41173472 | kaushal.shah@kasiakresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Anant Joshi, Dr. | ASMI | Principal Investigator |
| Nicolas Antao, Dr. | Hillway Clinic | Principal Investigator |
| Gauresh Palekar, Dr. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasiak Research Pvt Ltd | Recruiting | Thane | Maharashtra | 400610 | India |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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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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| Corticosteroid | Drug | Subjects will receive one injection of Corticosteroid in the lateral epicondyle space |
|
| Surya Orthopedic Clinic |
| Principal Investigator |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |