The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.
204 patients affected by knee osteoarthritis will be included in a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
Patients will be treated with a single injection of Homologous PRP (5 ml) in the knee joint affected by osteoarthritis.
Patients will be treated with a single injections of saline solution (5 ml) in the knee joint affected by osteoarthritis
Istituto Ortopedico Rizzoli
Bologna, Italy
RECRUITINGKOOS-Pain Score
KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain".
Time frame: 6 months FU
KOOS Score
KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). Each question is scored from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty. Score range 0-100 for each subscale
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
IKDC-Subjective Score
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function.
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Visual Analogue Scale (VAS)
VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable".
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
EQ-VAS
EQ-VAS Is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
EQ-5D (EuroQoL) Current Health Assessment
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EQ-5D is useful to evaluate the quality life of the patients
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Tegner Activity Level Scale
Tegner activity level scale allows to know the level of physical activity carried out by the patients. All patients will indicate the type of sporting activity performed and its frequency.
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis.
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Patient Acceptable Symptom State (PASS)
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up