Articular cartilage degradation is the main characteristic of osteoarthritis (OA), involving enzymatic and inflammatory mechanisms that change it into a chronic disease. Since articular cartilage shows limited regenerative ability, several intra-articular drugs have been developed in order to decrease inflammation and provide a better clinical outcome to the patient.
This study aims to compare effectiveness of the treatment with intra-articular administration of collagen-PVP versus hylan GF 20, using the International Knee Documentation Committee (IKDC) score, 6 months after treatment. Hypothesis to test is: If effectiveness of intra-articular collagen-PVP is not lower than hylan GF 20 treatment in knee osteoarthritis subjects, then, statistically significant difference would not exist in IKDC score mean increase among treatment groups, after six months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Infiltrations of 1.5 ml collagen-polyvinyl pyrrolidone (collagen-PVP) plus 1 mL of 2% xylocaine without epinephrine, administered by intraarticular injections (three doses, one each 7 days)
Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)
Gabriel Horta Baas
Mérida, Yucatán, Mexico
RECRUITINGInternational Knee Documentation Committee (IKDC).
Change from Baseline in International Knee Documentation Committee (IKDC) subjective score at 6 months. The IKDC subjetive form is a patient-reported outcome, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).The IKDC is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (add the score for each item and divide by the maximum possible). The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
Time frame: Evaluation will be conducted at Baseline and 6 months after first infiltration
Change in Pain Intensity
Change from Baseline in Pain Intensity score (MOS Pain severity scale) at 6 months. The Medical Outcomes Study (MOS) Pain Severity Scale is a 5-item scale to assess pain intensity (average and at the most), frequency, and duration over the last 7 days. Scores range from 0-100; higher score indicates more pain
Time frame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
Change in quality of life: EQS-5D
Change from Baseline in quality of life (EQS-5D) score at 6 months.
Time frame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
Changes in Urine Collagen Type II C-telopeptide Fragments
Changes from baseline in Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 6 months
Time frame: Evaluation will be conducted at Baseline, and 6 months after first infiltration
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