Open Treatment for Pain and Inflammation in Knee Osteoarthrosis With Platelet-rich Plasma, Comparative Study With Hyaluronic Acid
Overview
- Phase
- Phase 3
- Intervention
- Platelet Rich Plasma
- Conditions
- Osteoarthritis
- Sponsor
- Karla Andrea Arias Varela
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Changes in pain levels and functionality
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Karla Andrea Arias Varela
Clinical Research
Varela, Karla Andrea Arias, M.D.
Eligibility Criteria
Inclusion Criteria
- Not provided
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. .
Arms & Interventions
Platelet Rich Plasma
Four intra-articular infiltration of autologous PRP every 15 days.
Intervention: Platelet Rich Plasma
Hyaluronic Acid
One intra-articular infiltration of SYNVISC-ONE
Intervention: Hyaluronic Acid
Outcomes
Primary Outcomes
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.