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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis Gonarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Double-blind masking.

Study Groups

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Collagen-PVP

Collagen-polyvinyl pyrrolidone (collagen-PVP).

Group Type EXPERIMENTAL

Collagen-PVP

Intervention Type DRUG

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)

Hylan G-F 20

Hylan G-F 20.

Group Type ACTIVE_COMPARATOR

Hylan G-F 20

Intervention Type DEVICE

Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)

Interventions

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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)

Intervention Type DRUG

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)

Intervention Type DEVICE

Other Intervention Names

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Fibroquel Synvisc

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No