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Evaluation of Two Types of PRP in Knee Osteoarthritis

Primary Purpose

Osteoarthrosis

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Platelets Rich Plasma
Leucocyte - Platelets Rich Plasma
Hialuronic Acid
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthrosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hemotherapy and Hematology CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Osteoarthrits G II and III

Osteoarthrits GIV

Arm Description

Group of treatment

Group of treatment

Outcomes

Primary Outcome Measures

Womac

Secondary Outcome Measures

Full Information

First Posted
September 30, 2016
Last Updated
September 30, 2016
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02923310
Brief Title
Evaluation of Two Types of PRP in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osteoarthrits G II and III
Arm Type
Experimental
Arm Description
Group of treatment
Arm Title
Osteoarthrits GIV
Arm Type
Experimental
Arm Description
Group of treatment
Intervention Type
Biological
Intervention Name(s)
Platelets Rich Plasma
Intervention Type
Biological
Intervention Name(s)
Leucocyte - Platelets Rich Plasma
Intervention Type
Drug
Intervention Name(s)
Hialuronic Acid
Primary Outcome Measure Information:
Title
Womac
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Hemotherapy and Hematology Center
City
Campinas
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José F Lana, MD
Phone
+5519999600602
Email
osefabiolana@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Two Types of PRP in Knee Osteoarthritis

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