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

Primary Purpose

Knee Osteoarthritis, Gonarthrosis

Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Collagen-PVP
Hylan G-F 20
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Intraarticular Injections, Viscosupplementations, Type I Collagen, Patient Outcome Assessment, Patient Reported Outcome Measures

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Gabriel Horta BaasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Collagen-PVP

Hylan G-F 20

Arm Description

Collagen-polyvinyl pyrrolidone (collagen-PVP).

Hylan G-F 20.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Change in quality of life: EQS-5D
Change from Baseline in quality of life (EQS-5D) score at 6 months.
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

Full Information

First Posted
July 11, 2019
Last Updated
July 15, 2019
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04019782
Brief Title
Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Gonarthrosis
Keywords
Osteoarthritis, Intraarticular Injections, Viscosupplementations, Type I Collagen, Patient Outcome Assessment, Patient Reported Outcome Measures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes Assessor
Masking Description
Double-blind masking.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Collagen-PVP
Arm Type
Experimental
Arm Description
Collagen-polyvinyl pyrrolidone (collagen-PVP).
Arm Title
Hylan G-F 20
Arm Type
Active Comparator
Arm Description
Hylan G-F 20.
Intervention Type
Drug
Intervention Name(s)
Collagen-PVP
Other Intervention Name(s)
Fibroquel
Intervention 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)
Intervention Type
Device
Intervention Name(s)
Hylan G-F 20
Other Intervention Name(s)
Synvisc
Intervention Description
Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)
Primary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC).
Description
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.
Time Frame
Evaluation will be conducted at Baseline and 6 months after first infiltration
Secondary Outcome Measure Information:
Title
Change in Pain Intensity
Description
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
Time Frame
Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
Title
Change in quality of life: EQS-5D
Description
Change from Baseline in quality of life (EQS-5D) score at 6 months.
Time Frame
Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
Title
Changes in Urine Collagen Type II C-telopeptide Fragments
Description
Changes from baseline in Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 6 months
Time Frame
Evaluation will be conducted at Baseline, and 6 months after first infiltration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel J Horta-Baas, MD, Msc
Phone
529998360846
Email
gabho@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Romero-Figueroa, MD, PhD
Email
sromero61@hotmail.com
Facility Information:
Facility Name
Gabriel Horta Baas
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel J Horta Baas, MD, Msc
Phone
529993860846
Email
gabho@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19453649
Citation
Furuzawa-Carballeda J, Munoz-Chable OA, Barrios-Payan J, Hernandez-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.
Results Reference
background
PubMed Identifier
19397687
Citation
Furuzawa-Carballeda J, Munoz-Chable OA, Macias-Hernandez 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.
Results Reference
background
PubMed Identifier
22545014
Citation
Furuzawa-Carballeda J, Lima G, Llorente L, Nunez-Alvarez C, Ruiz-Ordaz BH, Echevarria-Zuno S, Hernandez-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.
Results Reference
background

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

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