NCT04792060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

February 20, 2021

Last Update Submit

March 8, 2023

Conditions

Distal Ulna Fractures

Outcome Measures

Primary Outcomes (1)

  • Management of Distal Ulna Fractures Using Hook Plate

    surgery

    6 months

Study Arms (1)

adult patients with distal ulna fractures

EXPERIMENTAL

adult patients with distal ulna fractures

Procedure: Hook plate

Interventions

Hook platePROCEDURE

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

Also known as: Distal ulna anatomical plate
adult patients with distal ulna fractures

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Skeletally mature distal ulna fracture with or without radius fracture.

You may not qualify if:

  • Pathological fracture Skeletally immaturity Neurovascular problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • salah roshdy ahmed, professor

    Sohag University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

February 20, 2021

First Posted

March 10, 2021

Study Start

April 1, 2021

Primary Completion

November 1, 2022

Study Completion

November 20, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

• 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.

Locations

EG(1)