Clinical trial NCT03477630: Treatment of Osteoarthrosis of the Knee With Platelet Rich Plasma, Comparative Study With Hyaluronic Acid
Official title: Open Treatment for Pain and Inflammation in Knee Osteoarthrosis With Platelet-rich Plasma, Comparative Study With Hyaluronic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: gonarthrosis
Lead sponsor: Varela, Karla Andrea Arias, M.D.
Sponsor class: INDIV
First posted: 2018-03-26
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, cohort, prospective controlled, randomized study with one year of follow-up.
Primary purpose: TREATMENT

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.

Eligibility 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 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)

Primary outcomes:
measure: Changes in pain levels and functionality
timeFrame: Baseline, 3 months, 6 months and 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Hospital Clínica Bíblica
Study officials:
affiliation: FIFA MD
name: Carlos Palavicini
role: STUDY_DIRECTOR
References:
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.
citation: Carrillo-Mora P, Gonzalez-Villalva A, Macias-Hernandez SI, Villasenor CP. [Platelets-rich plasma: a versatile tool for regenerative medicine?]. Cir Cir. 2013 Jan-Feb;81(1):74-82. Spanish.
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.
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 Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015.