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

• Status: Active, not recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is using Plasma Rich Platelets to improve the negative symptoms of adult patients with osteoarthrosis of the knee. Half of the patients receive Plasma Rich Platelets. The other half receives hyaluronic acid.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karla Andrea Arias Varela
• Treatments: Hyaluronic Acid

Criteria

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 alterations that contraindicate the treatment.

5. Informed consent in writing from the patient.

6. The patient is able to understand the nature of the study

Exclusion Criteria:

1. Allergic to the egg

2. Alteration in blood tests for platelet 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 Lúes ).

4. Participant who presents normal paper 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 who presents before the procedure a platelet count in whole blood outside the range of normality (150.00 to 450,000).

13. Participant with infectious diseases active in blood. 14. Patients with anticoagulant treatment (warfarin, heparin) in the last 6 months.

15. Participant with a history of skin, muscle or bone cancer in the lower limbs.

16. Participant with psychological, emotional, social problems or any other situation that may interfere with the requirements of the study.

17. Participant hospitalized for medical or surgical reasons.18. Participants with an arthroscopy in the last 6 months.

19. Participants with severe osteoarthritis of the knee (Varo or Valgo)