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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001056-19 | EudraCT Number |
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The overall objective of the study is to assess the effectiveness of the treatment of degenerative rotator cuff tendinopathy using the application of plasma rich in growth factors (PRGF).
Main objective:
To show more effectiveness after 6 months of treatment with PRGF, with an improvement in the reference test of more than 15% compared to the treatment with corticosteroids.
Secondary objective:
Study Group. PRGF
Blood extraction was performed in the pre-surgical area using a vacuum system. A total of 20 ml of blood (4 samples of 5 ml) per patient was collected in sterile sodium citrate tubes. PRGF was obtained following Anitua's technique. The tubes with citrated blood were centrifuged at 1,800 rpm for 8 min to obtain a concentrate of platelets suspended in plasma, which was separated into three fractions. Pipetting was carried out with extreme care in all steps, particularly in the last fraction where, in order to avoid inflammation, leukocytes present in the lowermost portion of the centrifuged plasma were not aspirated. PRGF was activated by adding calcium chloride 10%,immediately before infiltration. The proportion required for PRGF activation is 50 ml of activator per 1,000 ml of PRGF. Separation of plasma into three fractions and subsequent activation of the fractions for injection was performed in a laminar flow chamber.
Between the collection of blood and its subacromial administration must not exceed 90 minutes to avoid contamination.
Control group: Celestone Cronodose® (bethametasone).
They were given 3 infiltrations of 2 cc of Celestone cronodose® (bethametasone) every 21 days (If necessary, it could be administered after an application of a small quantity of a local anaesthetic).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma rich in growth factors (PRGF) | Experimental | This group will receive a total of three intraarticular injections of 6-8 ml. One injection every two weeks. |
|
| Celestone cronodose (bethametasone) | Active Comparator | This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma rich in growth factors (PRGF) | Biological |
| ||
| Celestone cronodose (Bethametasone) |
| Measure | Description | Time Frame |
|---|---|---|
| 15% of change in the score of the UCLA scale | Baseline and 6 months | |
| 15% of change in the score of the QuickDash scale | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the UCLA, Quickdash and Constant scales | 12 months | |
| Concentration of the platelet levels in the plasma administered and its relationship with the clinical effect measured with the UCLA and QuickDash scales. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Vaquerizo, MD, PhD | Hospital Universitario Principe de Asturias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario PrÃncipe de Asturias | Alcalá de Henares | Madrid | 28805 | Spain |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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