Surgical Management of Post-Traumatic Kyphosis | NCT05644574

Studies
Surgical Management of Post-Traumatic Kyphosis

NCT05644574

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 9, 2022Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Post-Traumatic Kyphosis

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

Dec 2022

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

Dec 1, 2022Estimated

Primary Completion Date

May 31, 2024Estimated

Completion Date

May 31, 2026Estimated

First Submitted Date

Dec 1, 2022

First Submission Date that Met QC Criteria

Dec 1, 2022

First Posted Date

Dec 9, 2022Actual

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

Dec 1, 2022

Last Update Posted Date

Dec 9, 2022Actual

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

Description Module

Brief Summary

The goal of this observational study is to examine the safety and efficacy of posterior sugary only in addressing post traumatic kyphosis. The main question[s]it aims to answer are:

Is it a safe procedure? Is it a sufficient approach to address deformity? Participants will be managed by posterior only surgery to address their deformity and will be assessed for the radiological and functional outcomes.

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

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in degree of kyphosis	we will measure the kyphosis in pre operative radiogragh and post operative radiograph to detect the change in the degree and the correction achieved after posterior only operative correction	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All patients with age range from 18-65 years old with PTK underwent corrective surgery and have been followed for at least 2 years with complete documentation.

Exclusion Criteria:

Traumatic cervical spine deformities
Pathologic fracture spine
Congenital or developmental cases
Degenerative cases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

All patients with age range from 18-65 years old with PTK underwent posterior only corrective surgery and have been followed for at least 2 years with complete documentation.

Sampling Method

Non-Probability Sample