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

July 15, 2019 updated by: Coordinación de Investigación en Salud, Mexico

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gabriel J Horta-Baas, MD, Msc
  • Phone Number: 529998360846
  • Email: gabho@hotmail.com

Study Contact Backup

Study Locations

  • Mexico
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Recruiting
        • Gabriel Horta Baas
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC).
Time Frame: 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.
Evaluation will be conducted at Baseline and 6 months after first infiltration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity
Time Frame: 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
Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration
Change in quality of life: EQS-5D
Time Frame: 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.
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
Time Frame: 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
Evaluation will be conducted at Baseline, and 6 months after first infiltration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

February 28, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 12, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2018-785-041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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