Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis

NCT03138317 | Unknown Phase 2

• 1 other identifier: 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Knee pain score measured by Visual Analogue Scale (VAS)

  Knee pain score measured by Visual Analogue Scale (VAS)

  24 weeks

Study Arms (3)

PRP

EXPERIMENTAL

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

Biological: PRP

Plasma

EXPERIMENTAL

Group 2: knee injection of Plasma

Biological: Plasma

Placebo

PLACEBO COMPARATOR

Group 3: knee injection of placebo (saline solution)

Biological: Placebo

Interventions

PRP BIOLOGICAL

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

PRP

Plasma BIOLOGICAL

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

Plasma

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• RDO Laboratory: collaborator

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 34560869 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Ricardo Fuller, PhD

CONTACT

+55 (11) 26616105.; fuller@uol.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant of Osteoarthritis ambulatory; PhD researcher.

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: May 3, 2017
• Study Start: January 2, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: May 11, 2017

Record last verified: 2017-04

Locations

BR (1)