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

Phase 3

• Conditions: Knee Osteoarthritis; Gonarthrosis
• Interventions: Device: Hylan G-F 20; Drug: Collagen-PVP

• Registration Number: NCT04019782
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-15
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17
• Study Start: 2019-08-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hylan G-F 20	Hylan G-F 20	Hylan G-F 20.
Collagen-PVP	Collagen-PVP	Collagen-polyvinyl pyrrolidone (collagen-PVP).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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.

Trial Locations

Locations (1)

Gabriel Horta Baas; 🇲🇽 Merida, Yucatan, Mexico