Clinical Outcome of Implant Removal Versus Retention Afte... | NCT04597567

Studies
Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Fractures

NCT04597567

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Oct 22, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Thoracolumbar

Interventions

Metal removal

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2020Estimated

Primary Completion Date

Oct 15, 2022Estimated

Completion Date

Nov 15, 2022Estimated

First Submitted Date

Oct 16, 2020

First Submission Date that Met QC Criteria

Oct 16, 2020

First Posted Date

Oct 22, 2020Actual

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

Oct 16, 2020

Last Update Posted Date

Oct 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metal removal	Active Comparator		Procedure: Metal removal
Metal retention	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metal removal	Procedure	Implant removal after fracture consolidation after posterior fixation of thoracolumbar spine fractures	Metal removal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EQ-5D-5L questionnaire	Measuring the quality of life after metal removal	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Oswestry disability index	Measuring the quality of life after metal removal or without removal	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-60 years
Posterior fixation
Six to nine months after fixation
Neurologically free patient
Fracture consolidation detected by ct
Types A3&A4 fractures

Exclusion Criteria:

unstable fractures B&C
pathological fractures
multilevel fractures
poly trauma patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Samir, Physician	Contact	01125098684		mahmoudsamir9463@gmail.com
Mahmoud Fouad, Phd	Contact	0114227270		Dr.m.fouad@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16814787	Background	Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.