The aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA
166 patients affected by patellofemoral osteoarthritis will be included in a double-blinded RCT. In this study one group of patients will be treated with 1 intra-articular injection of PRP (treatment arm) and one group will be treated with 1 intra-articular injection of HA (control arm). Patients will be followed-up with clinical evaluation at baseline and at 2.6.12 and 24 months. Questionnaires will be administered for clinical evaluations during the follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
166
Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis
Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral 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: 12 months
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, 2 month, 6 months, 12 months , 24 months follow-up
KOOS-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: baseline, 2 month, 6 months , 24 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, 2 month, 6 months, 12 months , 24 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, 2 month, 6 months, 12 months , 24 months follow-up
EQ-5D (EuroQoL) Current Health Assessment
EQ-5D is useful to evaluate the quality life of the patients
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Time frame: baseline, 2 month, 6 months, 12 months , 24 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, 2 month, 6 months, 12 months , 24 months follow-up
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis.
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
Time frame: baseline, 2 month, 6 months, 12 months , 24 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, 2 month, 6 months, 12 months , 24 months follow-up
The Kujala Anterior Knee Pain Scale (AKPS)
It's a 100-point scale consisting of 13 items with a score ranging from 5 to 10 points per item. A score of 0 points indicates the most severe limitation, while a score of 100 points indicates a normal situation.
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up