NCT03090698

Brief Summary

A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both associated in patients with severe osteoarthritis of the knee with follow up of one, three and six months.

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 P50-P75 for phase_4

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

March 2, 2017

Last Update Submit

March 20, 2017

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritiskneetreatment

Outcome Measures

Primary Outcomes (2)

  • Lysholm M1

    The outcome will be measured by Lysholm Score within one month. The results will be compared within each group from baseline and between the 3 groups.

    One month

  • KSS M1

    The outcome will be measured by Knee Society Score within one month. The results will be compared within each group from baseline and between the 3 groups.

    One month

Secondary Outcomes (4)

  • Lysholm M3

    Three months

  • KSS M3

    Three months

  • Lysholm M6

    Six months

  • KSS M6

    Six months

Study Arms (3)

Hylan

ACTIVE COMPARATOR

Intra-articular (knee) 6ml Hylan GF20 administration (single shot)

Drug: Hylan G-F 20

Hylan + Corticosteroid

ACTIVE COMPARATOR

Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)

Drug: Hylan G-F 20Drug: Triamcinolone

Corticosteroid

ACTIVE COMPARATOR

Intra-articular (knee) 1ml Triamcinolone administration (single shot)

Drug: Triamcinolone

Interventions

Hylan G-F 20DRUG

intra-articular administration

HylanHylan + Corticosteroid
TriamcinoloneDRUG

Intra-articular administration

CorticosteroidHylan + Corticosteroid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old;
  • Waiting for Total Knee Arthroplasty (at Hospital Federal dos Servidores queue);
  • Acceptance and signature of the TFCC;

You may not qualify if:

  • Infiltration of the knee for the past 6 months;
  • Allergic to any substance used in the study;
  • Prior infection in the knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital dos Servidores do Estado do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 20.221-903, Brazil

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

hylanTriamcinolone

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Andre Campos

    Hospital dos Servidores do Estado

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre Campos

CONTACT

+55 21 22913131andresiqueiracampos@hotmail.com

Vinicius Gameiro

CONTACT

drschott@bol.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 27, 2017

Study Start

September 1, 2015

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

BR(1)