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Completed

NCT Number: NCT03477630

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

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clínica Bíblica

San José, 1307-100, Costa Rica

About this study

28 participants with grade II-IV knee OA who met all the inclusion criteria and none of the exclusion criteria were recruited and selected. They were randomized into two groups, one received 4 doses of PRP and the other conventional hyalurinic acid treatment. Each patient underwent an evaluation of their baseline condition and physical examination of the affected knee by applying the functional and pain level questionnaires: WOMAC, VAS and LEQUESNE, after which each of the treatments was applied, respectively. The control group received 1 dose of SYNVISC-ONE, placed according to the standard intra-articular infiltration protocol, and group 2 received 4 intra-articular infiltrations of activated autologous PRP placed every 15 days. The patients were assessed at 3, 6 and 12 months by physical examination and the same surveys were applied to determine the progress and efficacy of the treatments using the same surveys. Finally, a statistical analysis was performed to compare the results between the two treatments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).
  • Simultaneous participation in another clinical trial or treatment with another product in the experimental phase in the 30 days prior to inclusion in the study.
  • 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.
  • Participants with an arthroscopy in the last 6 months.
  • Participants with severe osteoarthritis of the knee (Varo or Valgo)

Treatment and study plan

Platelet rich plasma

Biological

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

Other names: PRP

Hyaluronic acid

Drug

intra-articular infiltration of a single dose of HA

Other names: HA

Primary outcomes

  1. Changes in pain levels and functionality

    Time frame: Baseline, 3 months, 6 months and 12 months.

    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.

Sponsors and collaborators

Lead sponsor

Karla Andrea Arias Varela

Indiv

Registry information

Official study title

Open Treatment for Pain and Inflammation in Knee Osteoarthrosis With Platelet-rich Plasma, Comparative Study With Hyaluronic Acid

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2018
Registry last updated
Jun 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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