Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
54 participants
INTERVENTIONAL
2008-09-30
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rotator cuff repair plus PRP
Conventional arthroscopic repair of rotator cuff with application of PRP.
Platelet rich plasma
Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
Rotator cuff repair alone
Conventional arthroscopic repair of rotator cuff without application of PRP
Platelet rich plasma
Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Platelet rich plasma
Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Vascular-nerve lesions affecting the upper limb;
* Pregnancy;
* Immature skeleton;
* Comorbidities unmatched clinically;
* Osteoarthritis of the acromioclavicular joint symptomatic requiring surgical intervention;
* 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).
30 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Criogenesis
UNKNOWN
University of Sao Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eduardo Angeli Malavolta
Dr
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eduardo A Malavolta, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo - Orthopedic and Traumatology Department
Arnaldo A Ferreira Neto, PhD
Role: STUDY_DIRECTOR
University of Sao Paulo - Orthopedic and Traumatology Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of São Paulo - Orthopedics and traumatology department
São Paulo, São Paulo, Brazil
University of São Paulo
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0292/08
Identifier Type: -
Identifier Source: org_study_id