Fixation of Comminuted Distal Radius Fracture | NCT04798846

Studies
Fixation of Comminuted Distal Radius Fracture

NCT04798846

Sponsor

Sohag University

Status

Completed

Last Update Posted

Jun 21, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Distal Radius Fracture

Interventions

dorsal plating

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

Jun 2022

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

Apr 1, 2022Actual

Completion Date

Apr 1, 2022Actual

First Submitted Date

Feb 23, 2021

First Submission Date that Met QC Criteria

Mar 12, 2021

First Posted Date

Mar 15, 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

Jun 14, 2022

Last Update Posted Date

Jun 21, 2022Actual

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

comparison between different methods in fixation of comminuted distal radius fractures

Detailed Description

This clinical study aims at comparison of treatment outcomes of Spanning plate versus spanning External fixator in fixation of comminuted distal radius fracture.

The primary outcomes that we like to measure are pain, healing. Stiffness and range of 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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
External fixator	Active Comparator	patient treated by external fixator	Procedure: dorsal plating
Dorsal plate	Active Comparator	patient treated by dorsal spanning plate	Procedure: dorsal plating

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dorsal plating	Procedure	Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals	Dorsal plate External fixator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mayo modified wrist score	measure.grip strength	up to 6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria
- Skeletally mature patients aging 18 or more
- Comminuted distal radius fractures Fernandez type V
Exclusion criteria
- Age less than 18 year or more
- Patients with previous fracture affecting wrist joint in the same side.
- Parients with active infection in the affected joint
- Pathological fracture
- Neurological disorder (epilepsy…etc) Reheumatoid

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University Hospital		Sohag			Egypt

Type	Date	Date Unknown
Release	Jun 26, 2022
Reset	Apr 28, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 26, 2022			Apr 28, 2023

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

Intervention Browse Module

MeSH Terms

ID	Term
D016267	External Fixators

Ancestor Terms

ID	Term
D009984	Orthopedic Fixation Devices
D009983	Orthopedic Equipment
D013523	Surgical Equipment
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided