Management of Pilon Fractures With Versus Without Fibula... | NCT06182904

Studies
Management of Pilon Fractures With Versus Without Fibula Fixation

NCT06182904

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 27, 2023Actual

Enrollment

52Estimated

Phase

Not provided

Conditions

Pilon Fracture

Interventions

Dynamic compression plate

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 2023

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

Mar 21, 2024Estimated

Primary Completion Date

Feb 27, 2026Estimated

Completion Date

Mar 21, 2026Estimated

First Submitted Date

Jun 30, 2023

First Submission Date that Met QC Criteria

Dec 24, 2023

First Posted Date

Dec 27, 2023Actual

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 24, 2023

Last Update Posted Date

Dec 27, 2023Actual

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

Management of pilon fractures with versus without fibula fixation

Detailed Description

Comparing results with or without fibular fixation in :

Rate of bone union .
Functional return ( clinical outcomes)
Alignment of lower limb.

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

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Management of pilon fractures with fibula fixation	Device: Dynamic compression plate
2		Management of pilon fracture without fibula fixation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dynamic compression plate	Device	Fixation of fibula in some cases with dynamic compression plate	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fracture healing and bone union	by RUST score	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Incidece and rate of complications	Incidence and rate of complications (e.g. non-union, skin breakdown , infections and postraumatic malaligment) by AOFAS score	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with metaphyseal non rotational pilon or distal tibia : age ( 18 _ 65 )
No skin troubles
No infections
Non-dibetic patients.

Exclusion Criteria:

Patients who will not complete their follow up.
Skin troubles
Infections

Accepts Healthy Volunteers

Not provided

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

Management of pilon fractures with versus withot fibula fixation: prospective controlled study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mina Mofdy	Contact	01286998347		minamofdy55@gmail.com

Overall Officials

Not provided

Locations

Not provided