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

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

Sponsors

Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Source 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.

Overall Status Recruiting
Start Date August 1, 2019
Completion Date August 31, 2021
Primary Completion Date February 28, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
International Knee Documentation Committee (IKDC). Evaluation will be conducted at Baseline and 6 months after first infiltration
Secondary Outcome
Measure Time Frame
Change in Pain Intensity Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
Change in quality of life: EQS-5D Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
Changes in Urine Collagen Type II C-telopeptide Fragments Evaluation will be conducted at Baseline, and 6 months after first infiltration
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Collagen-PVP

Description: 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)

Arm Group Label: Collagen-PVP

Other Name: Fibroquel

Intervention Type: Device

Intervention Name: Hylan G-F 20

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

Arm Group Label: Hylan G-F 20

Other Name: Synvisc

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.

Gender: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Contact

Last Name: Gabriel J Horta-Baas, MD, Msc

Phone: 529998360846

Email: [email protected]

Location
Facility: Status: Contact: Gabriel Horta Baas Gabriel J Horta Baas, MD, Msc 529993860846 [email protected]
Location Countries

Mexico

Verification Date

July 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Collagen-PVP

Type: Experimental

Description: Collagen-polyvinyl pyrrolidone (collagen-PVP).

Label: Hylan G-F 20

Type: Active Comparator

Description: Hylan G-F 20.

Patient Data No
Study Design Info

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).

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking Description: Double-blind masking.

Source: ClinicalTrials.gov