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Use of PRP does not require a registered clinical trial
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The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.
Patients who have rotator cuff pathology as established by clinical exam and confirmed with MRI and have failed activity modification, will be enrolled in this study. They will receive dual platelet rich plasma (PRP) injections, one into the rotator cuff insertion and one into the area of the tendon proximal to the insertion, in one treatment session. PRP will be prepared through a double spin technique to create two 4 cc doses for injection. Patients will evaluated at 6 months, 1 year and two years for improvement in symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Dual injections of PRP - 4 ml injected into each location. The first injection was into the supraspinatus tendon insertion critical zone and bursal area with the patient seated. The second injection was performed with the patient prone into the glenohumeral intra-articular space under the supraspinatus tendon at, or just proximal to, the superior equator of the humeral head. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma (PRP) | Biological | Platelet Rich Plasma (PRP) prepared from patient blood, spun twice to concentrate platelets. 45 cc of initial blood resulting in 4cc of injectable PRP. |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH) | Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes. | change from baseline to 6 months |
| Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH) | Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes. | change from baseline to 12 months |
| Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH) | Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes. | change from baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for pain | The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain. | change from baseline to 6 months |
| Visual Analog Scale (VAS) for pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chadwick Prodromos, MD | Illinois Sportsmedicine and Orthopaedic Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois Sportsmedicine and Orthopaedic Centers | Glenview | Illinois | 60025 | United States |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain. |
| change from baseline to 12 months |
| Visual Analog Scale (VAS) for pain | The Visual Analog Scale is a single question about current pain level. Scoring ranges from 0 which is no pain to 100 which is worst possible pain. | change from baseline to 24 months |
| Global Improvement | Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved. | change from baseline to 6 months |
| Global Improvement | Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved. | change from baseline to 12 months |
| Global Improvement | Global improvement is a single question about percent improved compared to before treatment where 0 is not improved and 100 is completely improved. | change from baseline to 24 months |