Use of Synvisc® in Knee Osteoarthritis - Medico-economica... | NCT02195505

Studies
Use of Synvisc® in Knee Osteoarthritis - Medico-economical Study

NCT02195505

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 21, 2014Estimated

Enrollment

374Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2001

Primary Completion Date

Apr 2002Actual

Completion Date

Not provided

First Submitted Date

Jul 18, 2014

First Submission Date that Met QC Criteria

Jul 18, 2014

First Posted Date

Jul 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2014

Last Update Posted Date

Jul 21, 2014Estimated

Description Module

Brief Summary

The USAGE study aims at assessing on a long-term period (two years in average) the outcome in clinical or economical term of patients with knee osteoarthritis (OA) treated or not with Synvisc®, in the 1139.4 clinical trial.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

374Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Lequesne index	assessment of algo-functional severity of pathology	up to 2 years
Change in Womac index	assessment of symptom severity	up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Medical costs related to knee osteoarthritis		up to 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients have already been followed up on a nine-month period in a pragmatic medica-economical clinical trial (BI Trial No.: 1139.4)

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

rheumatological practice

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Synvisc®
Usual treatment of knee		nonsteroidal antiinflammatory drugs, antalgics