Knee Osteoarthritis, Gonarthrosis
Conditions
Keywords
Osteoarthritis, Intraarticular Injections, Viscosupplementations, Type I Collagen, Patient Outcome Assessment, Patient Reported Outcome Measures
Brief summary
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.
Detailed description
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.
Interventions
DRUGCollagen-PVP
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)
DEVICEHylan G-F 20
Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double-blind masking.
Intervention model description
Participants in one group receive drug A (Hylan G-F20) in parallel to participants in the other group, who receive drug B (Collagen-PVP).
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 40 and 80 years old * Osteoarthritis in the knee rated II or III (Kellgren-Lawrence Grading Scale). * Pain intensity (MOS Pain Severity Scale) greater than 40. * Subject able to understand, co-operative and reliable. * Written informed consent.
Exclusion criteria
* Acute arthritis in the knee. * Ongoing anticoagulant therapy. * Skin infection at the injection site. * Systemic or intraarticular (target knee) corticosteroids in the past 3 months. * Viscosupplementation (target knee) in the past year * Arthroscopy/osteotomy/surgery in the past 5 months (target knee). * Any surgery scheduled in the next 6 months * Concomitant rheumatic disease (rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, fibromyalgia). * Severe varus/valgus deformity (\>15°). * Frontal deformity greater than 20 degrees * History of allergy or hypersensitivity to hyaluronic acid or avian proteins * History/present evidence of: metabolic joint diseases; crystal arthropaties; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC). | Evaluation will be conducted at Baseline and 6 months after first infiltration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration | 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 |
| Change in quality of life: EQS-5D | Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration | Change from Baseline in quality of life (EQS-5D) score at 6 months. |
| Changes in Urine Collagen Type II C-telopeptide Fragments | Evaluation will be conducted at Baseline, and 6 months after first infiltration | Changes from baseline in Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 6 months |
Countries
Mexico
Contacts
Primary ContactGabriel J Horta-Baas, MD, Msc
Backup ContactMaria Romero-Figueroa, MD, PhD
Outcome results
None listed