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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: Platelet Rich Plasma; Drug: Hyaluronic Acid

• Registration Number: NCT03477630
• Lead Sponsor: Karla Andrea Arias Varela

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Study Start: 2019-02-14
• Primary Completion: 2020-07-25
• Study Completion: 2020-09-16
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma	Platelet Rich Plasma	Four intra-articular infiltration of autologous PRP every 15 days.
Hyaluronic Acid	Hyaluronic Acid	One intra-articular infiltration of SYNVISC-ONE

Primary Outcome Measures

Name	Time	Method
Changes in pain levels and functionality	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.

Trial Locations

Locations (1)

Hospital Clínica Bíblica; 🇨🇷 San José, Costa Rica