Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04019782
• Other study ID #: R-2018-785-041
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: July 2019
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Gabriel J Horta-Baas, MD, Msc
• Phone: 529998360846
• Email: gabho[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gonarthrosis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Collagen-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)

Device:
• Hylan 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)

Locations

Country	Name	City	State
Mexico	Gabriel Horta Baas	Merida	Yucatan

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Furuzawa-Carballeda J, Lima G, Llorente L, Nuñez-Álvarez C, Ruiz-Ordaz BH, Echevarría-Zuno S, Hernández-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. — View Citation

Furuzawa-Carballeda J, Muñoz-Chablé OA, Barrios-Payán J, Hernández-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. — View Citation

Furuzawa-Carballeda J, Muñoz-Chablé OA, Macías-Hernández 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International 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.	Evaluation will be conducted at Baseline and 6 months after first infiltration
Secondary	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	Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
Secondary	Change in quality of life: EQS-5D	Change from Baseline in quality of life (EQS-5D) score at 6 months.	Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
Secondary	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	Evaluation will be conducted at Baseline, and 6 months after first infiltration