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

Sponsor

Coordinación de Investigación en Salud, Mexico (Other)

Overall Status

Unknown status

CT.gov ID

NCT04019782

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis Gonarthrosis	Drug: Collagen-PVP Device: Hylan G-F 20	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).Participants in one group receive drug A (Hylan G-F20) "in parallel" to participants in the other group, who receive drug B (Collagen-PVP).

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Double-blind masking.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Feb 28, 2021

Anticipated Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Collagen-PVP Collagen-polyvinyl pyrrolidone (collagen-PVP).	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) Other Names: Fibroquel
Active Comparator: Hylan G-F 20 Hylan G-F 20.	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) Other Names: Synvisc

Arm

Intervention/Treatment

Experimental: Collagen-PVP

Collagen-polyvinyl pyrrolidone (collagen-PVP).

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)

Other Names:

Fibroquel

Active Comparator: Hylan G-F 20

Hylan G-F 20.

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)

Other Names:

Synvisc

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.