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Evaluation of Two Types of PRP in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02923310
Recruitment Status : Unknown
Verified September 2016 by Joyce Maria Annichino Bizzacchi, University of Campinas, Brazil.
Recruitment status was:  Recruiting
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Joyce Maria Annichino Bizzacchi, University of Campinas, Brazil

Brief Summary:
OOsteoarthritis (OA) is a chronic joint disease characterized by progressive degeneration of cartilage and bone tissue, leading to the appearance of subchondral cysts, osteophyte formation and synovial inflammation. Although the causes of OA are still poorly understood, biomechanical stresses able to reach the articular cartilage and subchondral bone, biochemical changes in cartilage and synovial membrane, as well as genetic factors are important items in its pathogenesis. Although there is no cure for OA, treatment is directed to each individual patient, seeking to minimize pain, maintain or improve joint range of motion and limit disability. New therapies able to accelerate regeneration and tissue repair process are being discussed. The viscosupplementation with hyaluronic acid (HA) have been shown to be an effective and safe treatment alternative in the fight against knee OA, in addition to HA, worth highlighting the therapeutic effects of growth factors derived from autologous platelets. The platelet-rich plasma (PRP) appears as an autologous therapy, non-immunogenic, able to induce healing and repair of bone soft tissue. This study aims to evaluate the clinical efficacy, comparing treatment with PRP and the combination of HA and PRP in the treatment of knee OA. To this, 120 will be selected OA patients with mild, moderate and severe (Grade II, III and IV). Selected patients will be scheduled for the procedures and randomly assigned randomly. In PRP be determined concentrations of the growth factor PDGF, TGFb 1, VEGF, EGF, by the method Bio Plex®.\. Functional evaluations will be conducted through questionnaires (WOMAC and SF-36) as measures of function and quality of self-reported life. The walking and strength test will be performed before and during periods of 90.180 and 360 days after the first application. The main motivation for the development of this study is the lack of randomized, double-blind clinical studies in the literature, and also based on the favorable results researchers have obtained, both with the use of HA, as the use of PRP in accelerating the process scar, preventing the development of arthrosis above. Therefore, we believe that the PRP, with its growth factors associated with synthetic HA play a synergistic action that should be studied in detail, in order to establish an effective therapeutic approach in the treatment of patients with knee OA.

Condition or disease Intervention/treatment Phase
Osteoarthrosis Biological: Platelets Rich Plasma Biological: Leucocyte - Platelets Rich Plasma Drug: Hialuronic Acid Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2013
Actual Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Osteoarthrits G II and III
Group of treatment
Biological: Platelets Rich Plasma
Biological: Leucocyte - Platelets Rich Plasma
Drug: Hialuronic Acid
Experimental: Osteoarthrits GIV
Group of treatment
Biological: Platelets Rich Plasma
Biological: Leucocyte - Platelets Rich Plasma
Drug: Hialuronic Acid



Primary Outcome Measures :
  1. Womac [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients with Osteoarthrits

Exclusion Criteria:

  • diabetes, rheumatoid arthritis, axial deviation (varus> 10 degrees valgus> 10 degrees), blood disorders (coagulopathy and platelet changes), cardiovascular diseases, infections, immunosuppression, patients on anticoagulant therapy or antiplatelet use of nonsteroidal anti-inflammatory 5 days before blood collection, patients with hemoglobin concentrations <11 and platelet count <150,000 mm³.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923310


Locations
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Brazil
Hemotherapy and Hematology Center Recruiting
Campinas, São Paulo, Brazil
Contact: José F Lana, MD    +5519999600602    osefabiolana@gmail.com   
Sponsors and Collaborators
University of Campinas, Brazil

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Responsible Party: Joyce Maria Annichino Bizzacchi, Professor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02923310     History of Changes
Other Study ID Numbers: 19466713.6.0000.5404
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases