Removal Wichita Fusion Nail After Knee Arthrodesis | NCT02045615

Studies
Removal Wichita Fusion Nail After Knee Arthrodesis

NCT02045615

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Nov 18, 2020Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Removal Wichita Fusion Nail After Knee Arthrodesis

Interventions

Proposed technique for removal of the Wichita Fusion Nail

Countries

Belgium

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

Nov 2020

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

Oct 2013Actual

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jan 21, 2014

First Submission Date that Met QC Criteria

Jan 23, 2014

First Posted Date

Jan 27, 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

Nov 16, 2020

Last Update Posted Date

Nov 18, 2020Actual

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

Description Module

Brief Summary

The purpose of this study is to make clear how difficult it is to remove osteosynthesis materials afterwards, so surgeons will think twice before inserting intramedullary nails. Also it offers an alternative methode to remove the Wichita Fusion Nail after arthrodesis has become.

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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional		Conventional technique for Wichita nail extraction
New		Proposed technique for Wichita nail extraction	Procedure: Proposed technique for removal of the Wichita Fusion Nail

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proposed technique for removal of the Wichita Fusion Nail	Procedure		New

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operation technique	Was the arthrodesis site left intact? How was the Nail removed? Time for operation?	first 4 months postop

Secondary Outcomes

Measure	Description	Time Frame
Mobility		1 year postop
Pain measurement following the Visual Analogue Scale		1 year postop
Major complications after removal

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Extraction of Wichita Fusion Nail

Exclusion Criteria:

All other kinds of intramedullairy nails used to become a solid knee arhrodesis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All patients who had to have their Wichita Fusion Nail extracted

Sampling Method

Non-Probability Sample