Treatment of Osteoarthrosis of the Knee With Platelet Rich Plasma, Comparative Study With Hyaluronic Acid

NCT03477630 | Completed Phase 3 DMC

• 1 other identifier: PRP 3.5 - 01 version 1.3
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To compare changes in functionality and pain level using questionnaires EVA, Lequesne and WOMAC in patients treated with 4 doses of 8 ml of autologous Platelet Rich Plasma every 15 days applied through intra-articular infiltration and patients treated with an intra-articular infiltration of 1 dose of SYNVISC-ONE ® 6 ml pre-filled syringe, placed according to standard protocol, in patients with OA grade II-IV.

Conditions

Osteoarthritis

Keywords

gonarthrosis

Outcome Measures

Primary Outcomes (1)

• Changes in pain levels and functionality

  Eva scale for the intensity of pain associated with activities of daily living and if sports activities are practiced. Lequesne index for knee osteoarthritis and physical function, pain and stiffness measured by Womac index.Each of the 3 questionnaires was evaluated at four different times: baseline, 3 months, 6 months and 12 months after treatment.

  Baseline, 3 months, 6 months and 12 months.

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

Four intra-articular infiltration of autologous PRP every 15 days.

Biological: Platelet Rich Plasma

Hyaluronic Acid

ACTIVE COMPARATOR

One intra-articular infiltration of SYNVISC-ONE

Drug: Hyaluronic Acid

Interventions

Platelet Rich Plasma BIOLOGICAL

intra-articular infiltration of 8 ml of autologous PRP every 15 days.

Also known as: PRP

Platelet Rich Plasma

Hyaluronic Acid DRUG

intra-articular infiltration of a single dose of HA

Also known as: HA

Hyaluronic Acid

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthrosis grade II, III and IV of Kellgren and Lawrence
• Chronic painful knee of mechanical characteristics.
• Absence of local or systemic septic process.
• Hematological and biochemical blood analysis without alterations that contraindicate the treatment.
• Informed consent in writing from the patient.
• Patient able to understand the nature of the study

You may not qualify if:

• Allergic to egg
• Alteration in blood tests for platelets count in whole blood (hemogram)
• Patients presenting positive serology for HIV 1 and 2, Hepatitis B \[HBsAg, Anti-HBV-Ab\], Hepatitis C \[Anti-HCV-Ab\] and VDRL ).
• Participant who presents platelets in the peripheral blood outside the range of normality (150.00 to 450,000).
• Patients with positive serology for HIV 1, and 2, VDRL, Hepatitis B \[HBsAg, Anti HBs\] Hepatitis C (HCV).
• Neoplastic disease
• Immunosuppressive states.
• Other pathologies or circumstances that compromise participation in the study according to medical criteria.
• The participant who has received intra-articular injection in knee with steroid deposit in the last 3 months. .
• Participant with religious or cultural conflicts due to the use of Platelet Rich Plasma.
• Participant with an activev infectious diseases in blood.
• Patients with anticoagulant treatment (warfarin, heparin) in the last 6 months.
• Participant with a history of skin, muscle or bone cancer in the lower limbs.
• Participant with psychological, emotional, social problems or any other situation that may interfere with the requirements of the study.
• Participant hospitalized for medical or surgical reasons.

Sponsors & Collaborators

• Karla Andrea Arias Varela: lead

Study Sites (1)

Hospital Clínica Bíblica

San José, 1307-100, Costa Rica

Location

Related Publications (4)

• Riboh JC, Saltzman BM, Yanke AB, Fortier L, Cole BJ. Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. Am J Sports Med. 2016 Mar;44(3):792-800. doi: 10.1177/0363546515580787. Epub 2015 Apr 29.

  PMID: 25925602 BACKGROUND

• Carrillo-Mora P, Gonzalez-Villalva A, Macias-Hernandez SI, Villasenor CP. [Platelets-rich plasma: a versatile tool for regenerative medicine?]. Cir Cir. 2013 Jan-Feb;81(1):74-82. Spanish.

  PMID: 23461926 BACKGROUND

• Shahid M, Kundra R. Platelet-rich plasma (PRP) for knee disorders. EFORT Open Rev. 2017 Mar 13;2(1):28-34. doi: 10.1302/2058-5241.2.160004. eCollection 2017 Jan.

  PMID: 28607768 BACKGROUND

• Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015.

  PMID: 25624776 RESULT

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Carlos Palavicini

  FIFA MD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research

Model Details: Open, cohort, prospective controlled, randomized study with one year of follow-up.

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 26, 2018
• Study Start: February 14, 2019
• Primary Completion: July 25, 2020
• Study Completion: September 16, 2020
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)