Management of Distal Ulna Fractures Using Hook Plate | NCT04792060

Studies
Management of Distal Ulna Fractures Using Hook Plate

NCT04792060

Sponsor

Sohag University

Status

Completed

Last Update Posted

Mar 10, 2023Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Distal Ulna Fractures

Interventions

Hook plate

Countries

Egypt

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

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

Apr 1, 2021Actual

Primary Completion Date

Nov 1, 2022Actual

Completion Date

Nov 20, 2022Actual

First Submitted Date

Feb 20, 2021

First Submission Date that Met QC Criteria

Mar 8, 2021

First Posted Date

Mar 10, 2021Actual

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

Mar 8, 2023

Last Update Posted Date

Mar 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 aim of this current prospective study is to evaluate the effectiveness of an open reduction and internal fixation {ORIF} by distal ulna hooked locking compression plate (lcp) in treatment of isolated displaced distal ulna fracture in adult " without concomitant distal radius fractures.

Detailed Description

The distal ulna is an important component in the forearm and wrist motion. Pronation-supination is a complex movement, combining the rotation of the radius around the ulna with a horizontal and axial translation. If the distal ulna fails to heal in the proper anatomical position maintaining its original length with significant residual angulation at the fracture site, and separation of the DRUJ in a transverse axis, then a more severe limitation of forearm motion

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
adult patients with distal ulna fractures	Experimental	adult patients with distal ulna fractures	Procedure: Hook plate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hook plate	Procedure	We used titanium 2.4 mm hooked distal ulnar locked plate used for fixation of distal ulna fractures , this plate have low profile which is anatomically precontoured

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Management of Distal Ulna Fractures Using Hook Plate	surgery	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Skeletally mature distal ulna fracture with or without radius fracture.

Exclusion Criteria:

Pathological fracture Skeletally immaturity Neurovascular problems

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
salah roshdy ahmed, professor	Sohag University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University		Sohag			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

• Patient still for 24 hours postoperative till discharge during this period follow up swelling and neurovascular complication and broad spectrum antibiotics will be taken.

Follow up of cases at 2weeks postoperative 1-3-6 months.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jun 6, 2023
Reset	Feb 9, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 6, 2023			Feb 9, 2024

Condition Browse Module

MeSH Terms

ID	Term
D000092503	Wrist Fractures

Ancestor Terms

ID	Term
D014954	Wrist Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided