- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01029574
Platelet Rich Plasma on Rotator Cuff Repair (PRP)
Platelet Rich Plasma on Arthroscopic Repair of the Complete Rotator Cuff Lesions: a Prospective and Randomized Study
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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São Paulo, Brazil
- University of Sao Paulo
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São Paulo, Brazil, 05403-010
- University of São Paulo - Orthopedics and traumatology department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Psychiatric disorders;
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rotator cuff repair plus PRP
Conventional arthroscopic repair of rotator cuff with application of PRP.
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Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
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Placebo Comparator: Rotator cuff repair alone
Conventional arthroscopic repair of rotator cuff without application of PRP
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Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
UCLA Score
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Constant Scores and Re-tear rate (MRI)
Time Frame: 12 months
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12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eduardo A Malavolta, MD, University of Sao Paulo - Orthopedic and Traumatology Department
- Study Director: Arnaldo A Ferreira Neto, PhD, University of Sao Paulo - Orthopedic and Traumatology Department
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0292/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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