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HYPOTHESIS:
The application of plasma rich in growth factors (PRGF) will improve the quality of life and functional capacity of patients diagnosed with knee osteoarthritis, providing better functional results than conventional treatment with viscosupplementation.
OPERATING ASSUMPTIONS
Following the initial administration of three doses of PRGF interspersed every 15 days, applied via intraarticular, patients will present an improvement in functional test (WOMAC and Lequesne scales) of 15% or more after 6 and 12 months compared to the control group with patients treated with hyaluronic acid.
Full description
OBJECTIVES
The overall objective of the study is to assess the effectiveness of the treatment with PRGF in the osteoarthritis of the knee.
Main objective:
Secondary objectives:
METHODOLOGY.STUDY DESIGN:
First Phase:
A randomized, single-blind, clinical trial will be performed to compare the effectiveness of 2 different treatment strategies (PRGF and hyaluronic acid) in patients with knee osteoarthritis.
Patients will be divided into two homogeneous groups using a randomization procedure by permuted blocks system.
The first group (experimental) will receive the treatment with PRGF; one cycle of three intraarticular doses every 15 days.
The control group, will receive viscosupplementation wih hyaluronic acid of high molecular weight (Durolane®). Its administration is performed in a one cycle of a single intraarticular dose.
Second phase :
An interim analysis of the main objective in the first phase at 6 months will be performed. If the clinical data indicate that the PRGF is more effective than hyaluronic acid and no serious adverse events were described, the investigators will carry out a second phase of extension, exploratory, open label, non randomized, starting-up after 12 months of the finish of the first phase (in order to wash out the effects of the treatment in the first phase). Patients who were treated with hyaluronic acid in the first phase will be offered to be treated with PRGF in two cycles of administration (the first one at the begining and the second one after 6 months) in order to know whether a two-cycles-based-treatment improves the results of a single-cycle-based-treatment.
STUDY VARIABLES
Within the study the investigators will analyze different variables:
Predicting Variables:
Outcome Variables :
The investigators will use specific tests to evaluate Osteoarthritis of the knee:
The results of the study questionnaires will be measured after 3, 6 and 12 months in both phases.
The WOMAC questionnaire assesses pain intensity in 5 different situations, the joint stiffness in 2 different situations and the functional capacity in 17 everyday situations. Each item is scored from 0 ( "no pain, or without stiffness or no difficulty" ) to 4 ( " Very much " ) . The total score ranges as follows : Pain 0-20 , stiffness 0-8 and Functional Capacity 0-68 .
The severity index of Lequesne for knee osteoarthritis quantifies the severity of disability or severity of osteoarthritis. The pain is measured in 3 items, the maximum distance walked and activities of daily living are measured in 4 situations. Scores ranges from 1-4 (mild inability) to >14 (where the failure is extremely serious).
The SF -36 is a health questionnaire . It is used in medical research. It provides an overview of the state of health of the person. Contains 36 questions addressing different aspects of the daily life of the person.
COLLECTION AND ANALYSIS .
At baseline patients before receiving the first infiltration, regardless of the study group, must complete the tests described earlier. Then, at 3, 6 and 12 months the patients will perform the same tests.
Analysis:
ETHICS
All patients must sign the informed consent before their inclusion. The study was approved by the ethics committee of the Principe de Asturias University Hospital.
The investigators are responsible to ensure the confidentiality of patient's data, and to act according to the Spanish Law of Protection of Personal Data (LO 15/ 1999).
STUDY LIMITATIONS .
Limitations of the study include the lack of control group treated with placebo. In this study a placebo-controlled group is not ethically acceptable, because the patient must undergo invasive procedures with associated risks and discomfort involved. Therefore, in our case we will use as a control group the patients treated with hyaluronic acid, considered as an alternative to surgical treatment of osteoarthritis of the knee .
Another bias that may occur is the loss of patients by different reasons. To prevent this problem, we will contact every month with patients by telephone to remind them the appointments at 3,6 and 12 months.
In the second phase all patients that had completed the first phase in the control group will have the possibility of treatment with two cycles with PRGF. Because it is considered to be very unlikely to remain a residual effect of hyaluronic acid after 12 months of receiving the first infiltration, homogeneity achieved by the randomization in the first phase is expected to be maintained in the second phase. It is considered that 12 months is a relatively short time interval in a longstanding chronic disease such as osteoarthritis of the knee. Just in case, a comparative analysis of the baseline characteristics will be performed and adjusted for differences that may be found. Finally, due to the sample size was estimated to detect a difference between a one cycle treatment with PRGF and hyaluronic acid in the first phase, it is possible that it could be insufficient for comparison in the second phase. Thus, the second phase is considered as exploratory.
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96 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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