NCT00949494

Brief Summary

Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative used to treat knee osteoarthritis (OA). Animal studies have shown that Synvisc can have favorable effects on cartilage when injected into joints. This study attempts to evaluate the effects of Synvisc when injected into knees of patients with knee OA by means of a specialized MRI technology (dGEMRIC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

July 29, 2009

Last Update Submit

September 9, 2019

Conditions

Osteoarthritis

Keywords

knee osteoarthritis, synvisc, hyaluronan, dGEMRIC,cartilage

Outcome Measures

Primary Outcomes (1)

  • Percent change in dGEMRIC Index (T1(Gd)) in femoral and tibial compartments

    3 and 6 months

Secondary Outcomes (1)

  • Subjects' global assessment of disease using a 10 point Likert scale

    3 and 6 months

Study Arms (2)

Synvisc

ACTIVE COMPARATOR
Device: Synvisc

Placebo

PLACEBO COMPARATOR
Device: Synvisc

Interventions

SynviscDEVICE

intra-articular, 3 weekly injections

Also known as: hyaluronan
PlaceboSynvisc

Eligibility Criteria

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

You may qualify if:

  • Males and females 40 to 80 years of age who meet the ACR Criteria for osteoarthritis of the knee.
  • Radiographic evidence of OA, Kellgren and Lawrence grade I to III on prior X-rays (taken within 6 months of the screening visit) or at screening. Only the tibio-femoral joint will be evaluated (patello-femoral disease will not be considered).
  • Mild to moderate levels of knee pain as determined by a VAS pain score of 3-6/10 that has been stable for at least 1 month prior to screening visit.
  • Stable management regimen for knee OA pain for at least 1 month prior to screening visit. Subjects can be managed by physical measures alone, simple analgesics, NSAIDs, nutriceuticals or other agents with no significant change in treatment regimen during the 1 month prior to screening visit.
  • Ability to comply with the requirements of the study
  • Able to maintain stable exercise/activity program during course of the study
  • \. Signed and dated consent form 7. Women of child-bearing potential should agree to the use of an appropriate method of contraception and have a confirmed negative pregnancy test at screening.

You may not qualify if:

  • Radiographic evidence of Kellgren and Lawrence grade IV OA
  • Knee pain \<3 or \>6 out of 10 on VAS pain scale.
  • Change in management regimen for knee OA during the preceding month.
  • Subjects with any metal implant such as cardiac pacemakers, spinal cord stimulators or bionic ear devices.
  • Subjects who are unable to receive gadolinium contrast agent injection because of contraindications.
  • Unable to undergo an MRI exam because of contraindication, e.g. claustrophobia.
  • Inflammatory arthritis, e.g. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus.
  • History of other diseases that may involve the study joint including inflammatory joint disease, crystalline disease, endocrinopathies, metabolic disease, knee infection of the chosen knee, neuropathic disorders, avascular necrosis, Paget's disease or tumors
  • Recent trauma to study joint.
  • Known loose bodies in the study joint.
  • Patients taking oral steroids.
  • Patients with active malignancy.
  • Patients who are either high-performance athletes or, in the opinion of the investigator, are highly sedentary and not likely to ambulate at least 20-30 minutes/day.
  • In the opinion of the investigator, the subject has an unstable medical condition.
  • Participating in another study or has participated in a study evaluating investigational drugs, devices or biologics within three months of enrollment in this study.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Northshore University Hospital

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Pottumarthi V Prasad, PhD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director Department of Radiology Center for Advanced MR Research

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

September 1, 2006

Primary Completion

June 1, 2008

Study Completion

February 1, 2009

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

US(2)