NCT04019782

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3 knee-osteoarthritis

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

July 11, 2019

Last Update Submit

July 15, 2019

Conditions

Knee OsteoarthritisGonarthrosis

Keywords

OsteoarthritisIntraarticular InjectionsViscosupplementationsType I CollagenPatient Outcome AssessmentPatient Reported Outcome Measures

Outcome Measures

Primary Outcomes (1)

  • 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.

    Evaluation will be conducted at Baseline and 6 months after first infiltration

Secondary Outcomes (3)

  • 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

Study Arms (2)

Collagen-PVP

EXPERIMENTAL

Collagen-polyvinyl pyrrolidone (collagen-PVP).

Drug: Collagen-PVP

Hylan G-F 20

ACTIVE COMPARATOR

Hylan G-F 20.

Device: Hylan G-F 20

Interventions

Collagen-PVPDRUG

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)

Also known as: Fibroquel
Collagen-PVP
Hylan G-F 20DEVICE

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

Also known as: Synvisc
Hylan G-F 20

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriel Horta Baas

Mérida, Yucatán, 97000, Mexico

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19453649BACKGROUND

  • 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.

    PMID: 19397687BACKGROUND

  • 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.

    PMID: 22545014BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisOsteogenesis Imperfecta, Type IV

Interventions

collagen-PVP

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Gabriel J Horta-Baas, MD, Msc

CONTACT

529998360846gabho@hotmail.com

Maria Romero-Figueroa, MD, PhD

CONTACT

sromero61@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double-blind masking.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants in one group receive drug A (Hylan G-F20) "in parallel" to participants in the other group, who receive drug B (Collagen-PVP).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 15, 2019

Study Start

August 1, 2019

Primary Completion

February 28, 2021

Study Completion

August 31, 2021

Last Updated

July 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)