Rotator Cuff TearsPhase 3PRPNCT01029574
Platelet Rich Plasma on Rotator Cuff Repair
A Phase 3 study testing Platelet rich plasma in people with Rotator Cuff Tears, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Repair of the rotator cuff has high rates of re-rupture (20-54%), despite good clinical results. Several ways to improve the healing tendon-bone are currently studied, among them the most used is the use of growth factors. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Platelet rich plasma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesBrazil
- Study dates
- Sep 2008to Dec 2013
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain or functional deficit in the shoulder to justify surgical intervention;
- Complete lesion(full thickness) of the supraspinatus tendon resulting from trauma or degenerative confirmed by MRI;
- Patients skeletally mature, regardless of sex;
- Signing the consent form.
Who cannot join
- Psychiatric disorders;
- Vascular-nerve lesions affecting the upper limb;
- Pregnancy;
- Immature skeleton;
- Comorbidities unmatched clinically;
- Osteoarthritis of the acromioclavicular joint symptomatic requiring surgical intervention;
Show all 17Show fewer
- Glenohumeral arthrosis grades 2, 3 and 4 Samilson and Prieto;
- Rotator Cuff Arthropathy grades IB, IIA and IIB of Seebauer;
- Active or recent infection;
- Neuropathic arthropathy;
- Previous surgery on the same shoulder operated;
- Patients with painful pathologies of the cervical spine;
- Patients diagnosed with fibromyalgia;
- Patients who do not understand or do not agree with the consent form;
- Fatty degeneration of the muscles of the MR resonance;
- Retraction of the tendon greater than 3cm (MRI or intraoperative);
- Subscapular or Infraspinatus rupture that needs repair (MRI or intraoperative).
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
University of São Paulo - Orthopedics and traumatology department
São Paulo, São Paulo, 05403-010
University of São Paulo
São Paulo, São Paulo
About this study
Official title: Platelet Rich Plasma on Arthroscopic Repair of the Complete Rotator Cuff Lesions: a Prospective and Randomized Study
Repair of the rotator cuff has high rates of re-rupture (20-54%), despite good clinical results. Several ways to improve the healing tendon-bone are currently studied, among them the most used is the use of growth factors. The platelet-rich plasma is a source of several growth factors, and is already used in various orthopedic procedures. The aim of this study is to evaluate the effectiveness of platelet-rich plasma in improve tendon-bone healing in arthroscopic rotator cuff repairs.
Read the detailed description
Rotator cuff repair(RCR) is a procedure widely performed in the shoulder surgery, given the high prevalence of this type of injury in the population. Regardless of the approach employed, the procedure consists of the rehabilitation of the rotator cuff to his bed. Despite the clinical results are highly satisfactory (success rate around 85%), studies using ultrasound and magnetic resonance imaging (MRI) showed a rate of re-rupture after surgery 20 to 54%. These levels of re-injury suggest a sub-optimal healing in the bone-tendon interface.
Attempts to improve the healing in place of the RMR has been extensively studied in the orthopedic literature. One is the use of growth factors (GF), cytokines play an important role in chemotaxis, cell proliferation and differentiation, as well as the synthesis of extracellular matrix, and that theoretically could have beneficial role in tissue repair.
The Platelet-Rich Plasma (PRP) is one of the most studied sources of GF. It is easy to prepare and non-immunogenic (is done with the patient's own blood), and has the further advantage of the presence of several FC (including PDGF, bFGF, TGF-B, VEGF, EGF, CTGF and IGF). This fact is important because the disease have different effects on different receivers during the various stages of healing.
The use of PRP in bone healing has been evaluated in several studies with conflicting results. There are preclinical studies demonstrating the beneficial effect of PRP on tendon and ligament repair. However, there is no published papers showing the effectiveness of the use of PRP on tendon-bone interface.
The aim of this study is to evaluate the effectiveness of PRP in enhancing the healing tendon-bone repair after injury of RC.
Will be operated patients with complete injury (full thickness) of the rotator cuff, divided into two groups randomly. The use of PRP or not will be decided by sealed envelopes, with 20 individuals in each group. The subjects will be assessed pre and postoperatively according to the criteria for the Constant and UCLA and with the help of MRI, being unknown to the evaluators to which group the patient belongs.
- Conditions
- Rotator Cuff Tears
- Being tested
- Platelet rich plasma
- Keywords
- Rotator cuff lesions, Platelet rich plasma, Arthroscopic repair
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaOther
Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
| Study group | Role | What they receive |
|---|---|---|
| Rotator cuff repair plus PRP | Experimental | Conventional arthroscopic repair of rotator cuff with application of PRP. Receives: Other: Platelet rich plasma |
| Rotator cuff repair alone | Placebo comparator | Conventional arthroscopic repair of rotator cuff without application of PRP Receives: Other: Platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Score
Measured: 12 months
Secondary outcomes (1)
Constant Scores and Re-tear rate (MRI)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Criogenesis
- Responsible party
- Principal investigator, Eduardo Angeli Malavolta, University of Sao Paulo
- Investigators
- Eduardo A Malavolta, MD, Principal investigator, University of Sao Paulo - Orthopedic and Traumatology DepartmentArnaldo A Ferreira Neto, PhD, Study director, University of Sao Paulo - Orthopedic and Traumatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029574
- Sponsor's protocol ID
- 0292/08
- Acronym
- PRP
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2009
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Malavolta EA, Gracitelli MEC, Assuncao JH, Ferreira Neto AA, Bordalo-Rodrigues M, de Camargo OP. Clinical and Structural Evaluations of Rotator Cuff Repair With and Without Added Platelet-Rich Plasma at 5-Year Follow-up: A Prospective Randomized Study. Am J Sports Med. 2018 Nov;46(13):3134-3141. doi: 10.1177/0363546518795895. Epub 2018 Sep 20.
PubMed 30234999
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma on Arthroscopic Repair of the Complete Rotator Cuff Lesions: a Prospective and Randomized Study
- ClinicalTrials.gov ID
- NCT01029574
- Acronym / sponsor ID
- PRP / 0292/08
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator cuff lesions, Platelet rich plasma, Arthroscopic repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Criogenesis
- Study start
- Sep 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Dec 2009 (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.
Repair of the rotator cuff has high rates of re-rupture (20-54%), despite good clinical results. Several ways to improve the healing tendon-bone are currently studied, among them the most used is the use of growth factors. The platelet-rich plasma is a source of several growth factors, and is already used in various orthopedic procedures. The aim of this study is to evaluate the effectiveness of platelet-rich plasma in improve tendon-bone healing in arthroscopic rotator cuff repairs.
Detailed description
Rotator cuff repair(RCR) is a procedure widely performed in the shoulder surgery, given the high prevalence of this type of injury in the population. Regardless of the approach employed, the procedure consists of the rehabilitation of the rotator cuff to his bed. Despite the clinical results are highly satisfactory (success rate around 85%), studies using ultrasound and magnetic resonance imaging (MRI) showed a rate of re-rupture after surgery 20 to 54%. These levels of re-injury suggest a sub-optimal healing in the bone-tendon interface.
Attempts to improve the healing in place of the RMR has been extensively studied in the orthopedic literature. One is the use of growth factors (GF), cytokines play an important role in chemotaxis, cell proliferation and differentiation, as well as the synthesis of extracellular matrix, and that theoretically could have beneficial role in tissue repair.
The Platelet-Rich Plasma (PRP) is one of the most studied sources of GF. It is easy to prepare and non-immunogenic (is done with the patient's own blood), and has the further advantage of the presence of several FC (including PDGF, bFGF, TGF-B, VEGF, EGF, CTGF and IGF). This fact is important because the disease have different effects on different receivers during the various stages of healing.
The use of PRP in bone healing has been evaluated in several studies with conflicting results. There are preclinical studies demonstrating the beneficial effect of PRP on tendon and ligament repair. However, there is no published papers showing the effectiveness of the use of PRP on tendon-bone interface.
The aim of this study is to evaluate the effectiveness of PRP in enhancing the healing tendon-bone repair after injury of RC.
Will be operated patients with complete injury (full thickness) of the rotator cuff, divided into two groups randomly. The use of PRP or not will be decided by sealed envelopes, with 20 individuals in each group. The subjects will be assessed pre and postoperatively according to the criteria for the Constant and UCLA and with the help of MRI, being unknown to the evaluators to which group the patient belongs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff repair plus PRP | Experimental | Other: Platelet rich plasmaConventional arthroscopic repair of rotator cuff with application of PRP. |
| Rotator cuff repair alone | Placebo comparator | Other: Platelet rich plasmaConventional arthroscopic repair of rotator cuff without application of PRP |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pain or functional deficit in the shoulder to justify surgical intervention;
- Complete lesion(full thickness) of the supraspinatus tendon resulting from trauma or degenerative confirmed by MRI;
- Patients skeletally mature, regardless of sex;
- Signing the consent form.
Key exclusion criteria (17 listed)
- Psychiatric disorders;
- Vascular-nerve lesions affecting the upper limb;
- Pregnancy;
- Immature skeleton;
- Comorbidities unmatched clinically;
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 |
|---|---|---|
| Platelet rich plasmaUltra-centrifuged PRP, 40ml, in the liquid way, after portal closure. | Other | Rotator cuff repair alone, Rotator cuff repair plus PRP |
Primary outcome
UCLA Score
Time frame: 12 months
1 secondary outcome
Constant Scores and Re-tear rate (MRI)
Time frame: 12 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 3 Dec 2014.
- Derived from this study: PubMed 30234999Malavolta EA, Gracitelli MEC, Assuncao JH, Ferreira Neto AA, Bordalo-Rodrigues M, de Camargo OP. Clinical and Structural Evaluations of Rotator Cuff Repair With and Without Added Platelet-Rich Plasma at 5-Year Follow-up: A Prospective Randomized Study. Am J Sports Med. 2018 Nov;46(13):3134-3141. doi: 10.1177/0363546518795895. Epub 2018 Sep 20.
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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.
Eduardo A Malavolta, MD principal investigator
University of Sao Paulo - Orthopedic and Traumatology Department
Arnaldo A Ferreira Neto, PhD study director
University of Sao Paulo - Orthopedic and Traumatology Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet rich plasma in people with Rotator Cuff Tears, run by University of Sao Paulo at 2 sites in Brazil.
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 4 inclusion and 17 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. Some participants in this study may receive a placebo. 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?
UCLA Score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029574, which also lists 1 linked publication.
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 3 Dec 2014.