Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03138317
• Other study ID #: 2
• Status: Recruiting
• Phase: Phase 2
• First received: April 16, 2017
• Last updated: May 10, 2017
• Start date: January 2, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: April 2017
• Source: University of Sao Paulo
• Contact: Ricardo Fuller, PhD
• Phone: +55 (11) 26616105.
• Email: fuller[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Men and women aged from 45 to 80 years

2. Fulfill criteria for knee osteoarthritis of the ACR - American College of Rheumatology (Altman et al., 1986)

3. Radiographic classification 2 or 3 by Kellgren and Lawrence score

4. Relate pain in the last week of 3 to 8 points on the Visual Analogue Scale - EVA (Bellamy et al., 1988)

Exclusion Criteria:

1. Use of analgesics, NSAIDs and myorelaxants less than a week before the start of the study.

2. 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.

3. Infiltration of corticosteroid or infiltration with hyaluronic acid in the six months prior to the start of the study.

4. Intra-articular infiltration with any medication in any other joint less than 1 month after inclusion;

5. Introduction of any medical or physiotherapeutic intervention in the last 3 months (rehabilitation, acupuncture, cane, orthotics, etc.) for locomotor system;

6. Body Mass Index (BMI) greater than 35.

7. Presence of other types of arthropathies such as rheumatoid arthritis, diffuse connective tissue diseases, microcrystalline arthropathies, spondyloarthropathies and infectious arthropathies.

8. Symptomatic osteoarthritis of hip and feet

9. Presence of known meniscal or symptomatic ligament damage in the studied knee;

10. Previous surgery in the studied knee.

11. Difference in length in lower limbs greater than 1 cm.

12. Presence of cutaneous lesion on the surface of the joint studied;

13. Important scoliosis.

14. Blood dyscrasia or use of anticoagulant;

15. 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;

16. To be receiving pension benefit due to osteoarthritis of the knees.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• PRP
This group will receive a knee injection with 6 ml of platelet rich plasma (PRP)
• Plasma
This group will receive a knee injection with 6 ml of plasma.
• Placebo
This group will receive a knee injection with 6 ml saline solution.

Locations

Country	Name	City	State
Brazil	University of São Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	RDO Laboratory

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee pain score measured by Visual Analogue Scale (VAS)	Knee pain score measured by Visual Analogue Scale (VAS)	24 weeks