Investigation of the Added Value of a Big Toe Hinged Brac... | NCT00284284

Studies
Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus

NCT00284284

Sponsor

University Hospital, Ghent

Status

Withdrawn

Last Update Posted

Jul 2, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hallux Rigidus

Interventions

Use of a rehabilitation brace

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 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 30, 2006

First Submission Date that Met QC Criteria

Jan 30, 2006

First Posted Date

Jan 31, 2006Estimated

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 1, 2021

Last Update Posted Date

Jul 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Use of a rehabilitation brace	Device

Measure	Description	Time Frame
Mobility of the big toe joint

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hallux rigidus

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Rene Verdonk, MD, PhD	University Hospital, Ghent	Principal Investigator

Label	URL
Website University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D020859	Hallux Rigidus

Ancestor Terms

ID	Term
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases
D007592	Joint Diseases

Browse Leaves

Not provided

Browse Branches

Not provided