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Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

PRP

Plasma

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women aged from 45 to 80 years
Fulfill criteria for knee osteoarthritis of the ACR - American College of Rheumatology (Altman et al., 1986)
Radiographic classification 2 or 3 by Kellgren and Lawrence score
Relate pain in the last week of 3 to 8 points on the Visual Analogue Scale - EVA (Bellamy et al., 1988)

Exclusion Criteria:

Use of analgesics, NSAIDs and myorelaxants less than a week before the start of the study.
Use of slow-acting drugs in osteoarthritis started less than 8 weeks before the start of the study. For cases that they have been in use for more than 8 weeks, they should be maintained until the end of the week.
Infiltration of corticosteroid or infiltration with hyaluronic acid in the six months prior to the start of the study.
Intra-articular infiltration with any medication in any other joint less than 1 month after inclusion;
Introduction of any medical or physiotherapeutic intervention in the last 3 months (rehabilitation, acupuncture, cane, orthotics, etc.) for locomotor system;
Body Mass Index (BMI) greater than 35.
Presence of other types of arthropathies such as rheumatoid arthritis, diffuse connective tissue diseases, microcrystalline arthropathies, spondyloarthropathies and infectious arthropathies.
Symptomatic osteoarthritis of hip and feet
Presence of known meniscal or symptomatic ligament damage in the studied knee;
Previous surgery in the studied knee.
Difference in length in lower limbs greater than 1 cm.
Presence of cutaneous lesion on the surface of the joint studied;
Important scoliosis.
Blood dyscrasia or use of anticoagulant;
Presence of other diseases: severe depression, diabetes, coagulopathies, decompensated cardiovascular disease, infection, immunosuppression (allowed MTX up to 10 mg), systemic infectious disease, symptomatic lower limb vascular disease, neurological diseases, neoplasia or any other conditions that may compromise the procedure in doctor evaluation;
To be receiving pension benefit due to osteoarthritis of the knees.

Sites / Locations

University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

PRP

Plasma

Placebo

Arm Description

Goup 1: knee injection of Platelet Rich Plasma (PRP)

Group 2: knee injection of Plasma

Group 3: knee injection of placebo (saline solution)

Outcomes

Primary Outcome Measures

Knee pain score measured by Visual Analogue Scale (VAS)

Secondary Outcome Measures

Full Information

NCT ID

NCT03138317

First Posted

April 16, 2017

Last Updated

May 10, 2017

Sponsor

University of Sao Paulo

Collaborators

RDO Laboratory

1. Study Identification

Unique Protocol Identification Number

NCT03138317

Brief Title

Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis

Official Title

Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2, 2017 (Actual)

Primary Completion Date

May 30, 2018 (Anticipated)

Study Completion Date

May 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

Collaborators

RDO Laboratory

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Study was designed to evaluate efficacy of autologous platelet rich plasma (PRP) injections guided by ultrasound for treatment of knee osteoarthritis.

Detailed Description

Osteoarthritis (OA) is the most prevalent rheumatic disease in the world and its treatment is still relatively limited. The efficacy of platelet rich plasma (PRP) for treatment of osteoarthritis of knees has been demonstrated both in vitro and in vivo. Numerous studies published in literature show a good potential of PRP in treatment of osteoarthritis. However, results are not yet consistent due to methodological gaps such as lack of control, inadequate controls, inadequate assessment tools, inadequate matching for interventions, insufficient description of design and way of obtaining PRP. The aim of the study is to evaluate efficacy of autologous PRP injections guided by ultrasound for treatment of knee osteoarthritis. Patients will be randomized into three groups for ultrasound guided knee infiltrations: the first group will receive PRP, the second group will receive plasma and the third group will receive a placebo of physiological solution. All patients will be assessed using Visual Analog Pain Scale, WOMAC (Western Ontario McMasters University Osteoarthritis Index), Knee Injury and Osteoarthritis Outcome Score, conventional radiography, ultrasonography, and follow the standardization of results for clinical trials in Osteoarthritis (OMERACT-OARSI). Patients will be evaluated during clinical follow-up after 1, 4, 12 and 24 weeks.

6. Conditions and Keywords

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

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRP

Arm Type

Experimental

Arm Description

Goup 1: knee injection of Platelet Rich Plasma (PRP)

Arm Title

Plasma

Arm Type

Experimental

Arm Description

Group 2: knee injection of Plasma

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Group 3: knee injection of placebo (saline solution)

Intervention Type

Biological

Intervention Name(s)

PRP

Intervention Description

This group will receive a knee injection with 6 ml of platelet rich plasma (PRP)

Intervention Type

Biological

Intervention Name(s)

Plasma

Intervention Description

This group will receive a knee injection with 6 ml of plasma.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

This group will receive a knee injection with 6 ml saline solution.

Primary Outcome Measure Information:

Title

Knee pain score measured by Visual Analogue Scale (VAS)

Description

Knee pain score measured by Visual Analogue Scale (VAS)

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged from 45 to 80 years Fulfill criteria for knee osteoarthritis of the ACR - American College of Rheumatology (Altman et al., 1986) Radiographic classification 2 or 3 by Kellgren and Lawrence score Relate pain in the last week of 3 to 8 points on the Visual Analogue Scale - EVA (Bellamy et al., 1988) Exclusion Criteria: Use of analgesics, NSAIDs and myorelaxants less than a week before the start of the study. Use of slow-acting drugs in osteoarthritis started less than 8 weeks before the start of the study. For cases that they have been in use for more than 8 weeks, they should be maintained until the end of the week. Infiltration of corticosteroid or infiltration with hyaluronic acid in the six months prior to the start of the study. Intra-articular infiltration with any medication in any other joint less than 1 month after inclusion; Introduction of any medical or physiotherapeutic intervention in the last 3 months (rehabilitation, acupuncture, cane, orthotics, etc.) for locomotor system; Body Mass Index (BMI) greater than 35. Presence of other types of arthropathies such as rheumatoid arthritis, diffuse connective tissue diseases, microcrystalline arthropathies, spondyloarthropathies and infectious arthropathies. Symptomatic osteoarthritis of hip and feet Presence of known meniscal or symptomatic ligament damage in the studied knee; Previous surgery in the studied knee. Difference in length in lower limbs greater than 1 cm. Presence of cutaneous lesion on the surface of the joint studied; Important scoliosis. Blood dyscrasia or use of anticoagulant; Presence of other diseases: severe depression, diabetes, coagulopathies, decompensated cardiovascular disease, infection, immunosuppression (allowed MTX up to 10 mg), systemic infectious disease, symptomatic lower limb vascular disease, neurological diseases, neoplasia or any other conditions that may compromise the procedure in doctor evaluation; To be receiving pension benefit due to osteoarthritis of the knees.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ricardo Fuller, PhD

Phone

+55 (11) 26616105.

fuller@uol.com.br

Facility Information:

Facility Name

University of São Paulo

City

Sao Paulo

State/Province

ZIP/Postal Code

05403000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ricardo Fuller, PhD

Phone

+ 55 (11) 26616105.

fuller@uol.com.br

12. IPD Sharing Statement

Citations:

PubMed Identifier

34560869

Citation

Dorio M, Pereira RMR, Luz AGB, Deveza LA, de Oliveira RM, Fuller R. Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. BMC Musculoskelet Disord. 2021 Sep 24;22(1):822. doi: 10.1186/s12891-021-04706-7.

Results Reference

derived

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Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis

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