The study consists of 3 phases (enrollment, infiltrative procedure, and controls): * Identification by specialized orthopedic medical staff belonging to the SC Orthopedic and Trauma Clinic II of the Rizzoli Orthopedic Institute of subjects who meet the study inclusion criteria. Signing of informed consent form and completion of evaluation questionnaires. * infiltrative procedure * Patients will be clinically evaluated before the infiltration procedure and at 1, 3, 6, and 12 months after treatment by trained medical personnel (outcome assessors). Questionnaires will be administered for clinical evaluations before treatment and at these clinical checkups during follow-up. Any adverse events to treatment will also be assessed during follow-up visits. The duration and extent of joint swelling and pain following infiltration will be reported, and any drug therapies taken by the patient will be recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
a single intra-articular infiltration of 5 mL of PRP-O will be performed by the infiltrating physician. It is specified that the PRP-O used within the study will be produced following the guidelines and standards for the production of blood products for non-transfusion use as already in place at the Unified Metropolitan Transfusion Service IOR site. PRP (Platelet Rich Plasma) is produced from platelet pool from donor buffy coat. PRP contains 1,000,000 PLT/mml +/- 20%, as required by current regulations.
IRCCS - Istituto ortopedico Rizzoli
Bologna, Italy
RECRUITINGInternational Knee Documentation Committee score
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function.
Time frame: 6 months
International Knee Documentation Committee score
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function.
Time frame: baseline, 1, 3, 6, 12 months
Tegner Activity Level Scale
It is a questionnaire to find out the patient's level of physical activity
Time frame: baseline, 1, 3, 6, 12 months
Knee Injury and Osteoarthritis Outcome Score
The full questionnaire consists of five subscales and they cover: pain (9 items), symptoms (7 items of which two relate to stiffness), functions and activities of daily living (17 items) physical function, sports activities and leisure (5 items) and quality of life in relation to the knee (4 items). All items in the relevant subscales have the same response mode, use a 5-point Likert scale, and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "a severe difficulty). Score range 0-100 for each subscale.
Time frame: baseline, 1, 3, 6, 12 months
Visual Analogue Scale
visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable"
Time frame: baseline, 1, 3, 6, 12 months
objective parameter
range of motion and bilateral trans patellar and supra patellar circumferences for comparative analysis.
Time frame: baseline, 1, 3, 6, 12 months
Patient Acceptable Symptom State
Valuable tool for assessing patient satisfaction considering the patient's current degree of pain, function, and daily activity.
Time frame: baseline, 1, 3, 6, 12 months
Expectations of treatment efficacy
The patient should indicate at baseline what benefits he or she expects from the treatment.
Time frame: baseline
Overall judgment on treatment
The patient should indicate the degree of satisfaction related to the treatment performed at each follow-up.
Time frame: baseline, 1, 3, 6, 12 months
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