Back to results

Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

Primary Purpose

Rotator Cuff Tendinopathy

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Plasma rich in growth factors (PRGF)

Celestone cronodose (Bethametasone)

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinopathy focused on measuring plasma rich in growth factors, tendinopathy, traumatology, ,rotator cuff, effectiveness, plasma rich in platelets

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients within 40 -70 years old.
Both sex
Moderate to severe symptoms according to the QuickDASH scale during the last 3 months.
Patients with tendinitis, inflammatory or calcium, tendinosis or partial tears of the rotator cuff, diagnosed by ultrasound or MRI, evaluated by an expert radiologist and independent of research team.
Patients resistant to conservative treatment.

Exclusion Criteria:

Patients with complete tear of the rotator cuff diagnosed by ultrasound or MRI.
Patients who have previously received treatment with infiltrations in the last 6 months.
Patients with poorly controlled arterial Hypertension (AHT) and Diabetes mellitus.
Allergic to some of the components of Celestone Cronodose ®, either the drug or some of the excipients.
Patients on anticoagulants or antiplatelet therapy which cannot be reversed temporarily for the infiltrations.
Positive serology for sifilis, hepatitis B, hepatitis C or IHV I/II.
Uncapable to understand health questionnaires and / or complete them properly.
Women who might be pregnant and don't have a negative pregnancy test at the start of the study.
Breastfeeding women.

Sites / Locations

Hospital Universitario Príncipe de Asturias

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plasma rich in growth factors (PRGF)

Celestone cronodose (bethametasone)

Arm Description

This group will receive a total of three intraarticular injections of 6-8 ml. One injection every two weeks.

This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks.

Outcomes

Primary Outcome Measures

15% of change in the score of the UCLA scale

15% of change in the score of the QuickDash scale

Secondary Outcome Measures

changes in the UCLA, Quickdash and Constant scales

Concentration of the platelet levels in the plasma administered and its relationship with the clinical effect measured with the UCLA and QuickDash scales.

Full Information

NCT ID

NCT01915979

First Posted

July 18, 2013

Last Updated

December 18, 2018

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

1. Study Identification

Unique Protocol Identification Number

NCT01915979

Brief Title

Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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: 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.

Detailed Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tendinopathy

Keywords

plasma rich in growth factors, tendinopathy, traumatology, ,rotator cuff, effectiveness, plasma rich in platelets

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plasma rich in growth factors (PRGF)

Arm Type

Experimental

Arm Description

This group will receive a total of three intraarticular injections of 6-8 ml. One injection every two weeks.

Arm Title

Celestone cronodose (bethametasone)

Arm Type

Active Comparator

Arm Description

This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks.

Intervention Type

Biological

Intervention Name(s)

Plasma rich in growth factors (PRGF)

Intervention Type

Drug

Intervention Name(s)

Celestone cronodose (Bethametasone)

Primary Outcome Measure Information:

Title

15% of change in the score of the UCLA scale

Time Frame

Baseline and 6 months

Title

15% of change in the score of the QuickDash scale

Time Frame

Baseline and 6 months

Secondary Outcome Measure Information:

Title

changes in the UCLA, Quickdash and Constant scales

Time Frame

12 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients within 40 -70 years old. Both sex Moderate to severe symptoms according to the QuickDASH scale during the last 3 months. Patients with tendinitis, inflammatory or calcium, tendinosis or partial tears of the rotator cuff, diagnosed by ultrasound or MRI, evaluated by an expert radiologist and independent of research team. Patients resistant to conservative treatment. Exclusion Criteria: Patients with complete tear of the rotator cuff diagnosed by ultrasound or MRI. Patients who have previously received treatment with infiltrations in the last 6 months. Patients with poorly controlled arterial Hypertension (AHT) and Diabetes mellitus. Allergic to some of the components of Celestone Cronodose ®, either the drug or some of the excipients. Patients on anticoagulants or antiplatelet therapy which cannot be reversed temporarily for the infiltrations. Positive serology for sifilis, hepatitis B, hepatitis C or IHV I/II. Uncapable to understand health questionnaires and / or complete them properly. Women who might be pregnant and don't have a negative pregnancy test at the start of the study. Breastfeeding women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victor Vaquerizo, MD, PhD

Organizational Affiliation

Hospital Universitario Principe de Asturias

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Príncipe de Asturias

City

Alcalá de Henares

State/Province

Madrid

ZIP/Postal Code

28805

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy

We'll reach out to this number within 24 hrs