Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

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"

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

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

It's a standardized questionnaire to assess the condition of patients affected by knee osteoarthritis and includes assessment of pain, stiffness and physical functioning of the joints. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8) and 17 for functional limitation (range 0-68) that relate mainly to activities of daily living. The score is normalized on a 0-100 scale. Higher values indicate a worse outcome.

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".

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).

The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions.

Tegner activity level scale allows to know the level of physical activity carried out by the patients. Tegner's activity scale classifies the activity according to work and sports activities on a scale from 0 to 10. Zero represents disability because of knee problems and 10 represents soccer a national or international level

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".

Evaluation of the Range of Motion for comparative analysis.

The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up). All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse".

This examination is useful to do an initial assessment of possible meniscal extrusion in the interested knee joint.

The evaluation will be performed through the use of a thermal imaging camera. The thermal camera will allow to detect even small variation of knee temperature thus comparing and recording any thermographic changes in the inflammatory state of the joint before and after treatment.

Bilateral trans- and supra- patellar circumferences measurement for comparative analysis