Distraction Plate in Distal Radius Fractures and Internal Fixation; Complications and Mechanical Complication of Internal Rod Fixation Device - Clinical Trials Registry

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Procedure: Distraction Plate

Detailed Description

The plate is extended from the floor of the 2end extensor compartment at an intact radius to the 2end metacarpal by dual minimally invasive skin incisions.

One distal over 2end metacarpal and Other proximal over 2end extensor compartment at intact radius application of distal screws 1st, then the traction is done to restore radial length, radial inclination, and volar tilt followed by the application of proximal screws add wires to restore the joint congruity wire removal after 45 days, plate removal after 100 day follow up every 3 months till 1 year post-operative Assess the Functional Outcome Of the wrist joint after metal removal

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Egypt
- - Assuit, Egypt
    - Faculty of Medicine Assuit University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

oFirst peak is the young exposed to high energy trauma , fall from a height, polytrauma patients with extensive communition of metaphyseal and articular parts oSecond peak is old (over 60 years),with osteoporotic bone where even minor falls can cause extensive comminution

Description

Inclusion Criteria:

Skeletally mature patients
presented with multifragmentary distal radius fractures classify type 23-3C according to AO classification
articular with or without metaphyseal comminution
Very distal fractures 5 )osteoporotic bone fractures

Exclusion Criteria:

Dorsal soft tissue defect or tendon injuries
Metacarpal fractures (esp 2end MC)
open grade 3 fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Mayo Wrist Score (MMWS) Time Frame: Mean follow-up period is 1 year postoperative.	Combines subjective and objective parameters to evaluate wrist functionality.	Mean follow-up period is 1 year postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrist Range of Movement Time Frame: Mean follow-up period is 1 year postoperative.	Measurements include: Flexion (degrees) Extension (degrees) Pronation (degrees) Supination (degrees) Each measurement will be assessed separately using a goniometer.	Mean follow-up period is 1 year postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mina Hany Moris Zakhary

Investigators

Study Chair: Waleed Riad Saleh Waleed Riad Saleh Ramadan, preso doctor, Assiut University Hospitals
Study Director: Yasser Farouk Yasser Mohamed Farouk Fouad Ragheb, doctor, Assiut University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)