Status:
COMPLETED
Treatment of Osteoarthrosis of the Knee With Platelet Rich Plasma, Comparative Study With Hyaluronic Acid
Lead Sponsor:
Karla Andrea Arias Varela
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
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 throug...
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 o...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03477630
Start Date
February 14 2019
End Date
September 16 2020
Last Update
June 16 2022
Active Locations (1)
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1
Hospital Clínica Bíblica
San José, Costa Rica, 1307-100