Clinical trial NCT04019782: Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis
Official title: Efficacy Evaluation of Intraarticular Collagen-polyvinyl Pyrrolidone (Fibroquel®) vs Hylan G-F 20 (Synvisc®) in the Treatment of Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Knee Osteoarthritis
Gonarthrosis
Keywords: Osteoarthritis
Intraarticular Injections
Viscosupplementations
Type I Collagen
Patient Outcome Assessment
Patient Reported Outcome Measures
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2019-07-15
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: International Knee Documentation Committee (IKDC).
timeFrame: Evaluation will be conducted at Baseline and 6 months after first infiltration
Secondary outcomes:
measure: Change in Pain Intensity
timeFrame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
measure: Change in quality of life: EQS-5D
timeFrame: Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
measure: Changes in Urine Collagen Type II C-telopeptide Fragments
timeFrame: Evaluation will be conducted at Baseline, and 6 months after first infiltration
Other outcomes:
Locations:
city: Merida
country: Mexico
facility: Gabriel Horta Baas
state: Yucatan
Study officials:
References:
citation: Furuzawa-Carballeda J, Munoz-Chable OA, Barrios-Payan J, Hernandez-Pando R. Effect of polymerized-type I collagen in knee osteoarthritis. I. In vitro study. Eur J Clin Invest. 2009 Jul;39(7):591-7. doi: 10.1111/j.1365-2362.2009.02154.x.
citation: Furuzawa-Carballeda J, Munoz-Chable OA, Macias-Hernandez SI, Agualimpia-Janning A. Effect of polymerized-type I collagen in knee osteoarthritis. II. In vivo study. Eur J Clin Invest. 2009 Jul;39(7):598-606. doi: 10.1111/j.1365-2362.2009.02144.x. Epub 2009 Apr 23.
citation: Furuzawa-Carballeda J, Lima G, Llorente L, Nunez-Alvarez C, Ruiz-Ordaz BH, Echevarria-Zuno S, Hernandez-Cuevas V. Polymerized-type I collagen downregulates inflammation and improves clinical outcomes in patients with symptomatic knee osteoarthritis following arthroscopic lavage: a randomized, double-blind, and placebo-controlled clinical trial. ScientificWorldJournal. 2012;2012:342854. doi: 10.1100/2012/342854. Epub 2012 Apr 1.