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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477630
• Other study ID #: PRP 3.5 - 01 version 1.3
• Status: Completed
• Phase: Phase 3
• Start date: February 14, 2019
• Est. completion date: September 16, 2020

Study information

• Verified date: June 2022
• Source: Varela, Karla Andrea Arias, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 16, 2020
• Est. primary completion date: July 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria

1. Osteoarthrosis grade II, III and IV of Kellgren and Lawrence

2. Chronic painful knee of mechanical characteristics.

3. Absence of local or systemic septic process.

4. Hematological and biochemical blood analysis without alterations that contraindicate the treatment.

5. Informed consent in writing from the patient.

6. Patient able to understand the nature of the study

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)

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Biological:
• Platelet Rich Plasma
intra-articular infiltration of 8 ml of autologous PRP every 15 days.

Drug:
• Hyaluronic Acid
intra-articular infiltration of a single dose of HA

Locations

Country	Name	City	State
Costa Rica	Hospital Clínica Bíblica	San José

Sponsors (1)

Lead Sponsor	Collaborator
Karla Andrea Arias Varela

Country where clinical trial is conducted

Costa Rica, 

References & Publications (4)

Carrillo-Mora P, González-Villalva A, Macías-Hernández SI, Villaseñor CP. [Platelets-rich plasma: a versatile tool for regenerative medicine?]. Cir Cir. 2013 Jan-Feb;81(1):74-82. Review. Spanish. — View Citation

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 D — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.