Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy
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).
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.
- To assess the efficacy of the treatment after 12 months.
- Quantification of platelet levels in patients treated with plasma rich in growth factors and its correlation with the clinical effect.
Rotator Cuff Tendinopathy
Biological: Plasma rich in growth factors (PRGF)
Drug: Celestone cronodose (Bethametasone)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Role of Biological Therapy in Rotator Cuff Tendinopathy. Effectiveness of Plasma Rich in Growth Factors Regarding Functional Capacity and Pain Compared With the Conventional Treatment Using Steroids|
- 15% of change in the score of the UCLA scale [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
- 15% of change in the score of the QuickDash scale [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
- changes in the UCLA, Quickdash and Constant scales [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Concentration of the platelet levels in the plasma administered and its relationship with the clinical effect measured with the UCLA and QuickDash scales. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Plasma rich in growth factors
This group will receive a total of three intraarticular injections of 6-8 ml. One injection every two weeks.
|Biological: Plasma rich in growth factors (PRGF)|
Active Comparator: Celestone cronodose (bethametasone)
This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks.
|Drug: Celestone cronodose (Bethametasone)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915979
|Contact: Victor Vaquerizo, MD, PhD||+34 91 887 81 00 ext email@example.com|
|Contact: Miguel Angel Plasencia Arriba, MD, PhD||+34 91 887 81 00 ext 2454|
|Hospital Universitario Príncipe de Asturias||Recruiting|
|Alcalá de Henares, Madrid, Spain, 28805|
|Contact: Víctor Vaquerizo, Doctor +34 91 887 81 00 ext 2454 firstname.lastname@example.org|
|Principal Investigator: Víctor Vaquerizo, MD, PhD|
|Sub-Investigator: Miguel Angel Plasencia Arriba, MD, PhD|
|Sub-Investigator: Eulogio Benito Martin, MD|
|Sub-Investigator: Marta Garcia Lopez, MD|
|Sub-Investigator: Jose A Pareja Esteban, MD, PhD|
|Sub-Investigator: Alfredo Madruga, MD|
|Sub-Investigator: Elena Sanchez Villanueva, MD|
|Sub-Investigator: Miriam Gamo, MD|
|Sub-Investigator: Jesus A Jimenez del Rio, MD|
|Principal Investigator:||Victor Vaquerizo, MD, PhD||Hospital Universitario Principe de Asturias|