Rotator Cuff TendinopathyPhase 3NCT01915979
Effect of Plasma Rich in Growth Factors in Rotator Cuff Tendinopathy
A Phase 3 study testing Plasma rich in growth factors (PRGF) and Celestone cronodose (Bethametasone) in people with Rotator Cuff Tendinopathy, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- Plasma rich in growth factors (PRGF) and Celestone cronodose (Bethametasone)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to 31 Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
About this study
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
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.
Read the 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).
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- Plasma rich in growth factors (PRGF), Celestone cronodose (Bethametasone)
- Keywords
- plasma rich in growth factors, tendinopathy, traumatology, ,rotator cuff, effectiveness, plasma rich in platelets
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma rich in growth factors (PRGF)Biological
Celestone cronodose (Bethametasone)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Plasma rich in growth factors (PRGF) |
| Celestone cronodose (bethametasone) | Active comparator | This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks. Receives: Drug: Celestone cronodose (Bethametasone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
15% of change in the score of the UCLA scale
Measured: Baseline and 6 months
15% of change in the score of the QuickDash scale
Measured: Baseline and 6 months
Secondary outcomes (2)
changes in the UCLA, Quickdash and Constant scales
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor Vaquerizo, MD, PhD, Principal investigator, Hospital Universitario Principe de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915979
- Sponsor's protocol ID
- HUPA-EC-02-2012
- Other IDs
- 2012-001056-19
- Status last verified
- Dec 2018
- First submitted
- 18 Jul 2013
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01915979
- Acronym / sponsor ID
- HUPA-EC-02-2012
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- plasma rich in growth factors, tendinopathy, traumatology, ,rotator cuff, effectiveness, plasma rich in platelets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de AsturiasUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma rich in growth factors (PRGF) | Experimental | Biological: Plasma rich in growth factors (PRGF)This group will receive a total of three intraarticular injections of 6-8 ml. One injection every two weeks. |
| Celestone cronodose (bethametasone) | Active comparator | Drug: Celestone cronodose (Bethametasone)This group will receive a total of three intraarticular injections of 2ml. One injection every two weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma rich in growth factors (PRGF) | Biological | Plasma rich in growth factors (PRGF) |
| Celestone cronodose (Bethametasone) | Drug | Celestone cronodose (bethametasone) |
Primary outcome
15% of change in the score of the UCLA scale
Time frame: Baseline and 6 months
15% of change in the score of the QuickDash scale
Time frame: Baseline and 6 months
2 secondary outcomes
changes in the UCLA, Quickdash and Constant scales
Time frame: 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.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Vaquerizo, MD, PhD principal investigator
Hospital Universitario Principe de Asturias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plasma rich in growth factors (PRGF) and Celestone cronodose (Bethametasone) in people with Rotator Cuff Tendinopathy, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
15% of change in the score of the UCLA scale (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.