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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-14

Study Completion Date

2020-09-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open, cohort, prospective controlled, randomized study with one year of follow-up.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Platelet Rich Plasma

Four intra-articular infiltration of autologous PRP every 15 days.

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type BIOLOGICAL

intra-articular infiltration of 8 ml of autologous PRP every 15 days.

Hyaluronic Acid

One intra-articular infiltration of SYNVISC-ONE

Group Type ACTIVE_COMPARATOR

Hyaluronic Acid

Intervention Type DRUG

intra-articular infiltration of a single dose of HA

Interventions

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Platelet Rich Plasma

intra-articular infiltration of 8 ml of autologous PRP every 15 days.

Intervention Type BIOLOGICAL

Hyaluronic Acid

intra-articular infiltration of a single dose of HA

Intervention Type DRUG

Other Intervention Names

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PRP HA

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No