Fixation of Comminuted Distal Radius Fracture

June 14, 2022 updated by: Eslam Abdelnaby Abdelsabor, Sohag University

Spanning Plate Versus Spanning External Fixator in Fixation of Comminuted Distal Radius Fracture

comparison between different methods in fixation of comminuted distal radius fractures

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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
      • Sohag, Egypt
        • Sohag university hospital

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: External fixator
patient treated by external fixator
Procedure: dorsal plating
Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
Other Names:
  • External fixator
Active Comparator: Dorsal plate
patient treated by dorsal spanning plate
Procedure: dorsal plating
Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
Other Names:
  • External fixator

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Sohag University

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)

April 1, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh_Med_21_02_11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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