New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle (Prosthesis)

August 2, 2021 updated by: Sahar Ahmed Abdalbary, Cairo University

Comminuted Lateral Half Fracture of Clavicle is Most Common and at This Case Report Study the Investigators Introduce a New Prophesies for This Fracture

This study to evaluate the efficacy of new prosthesis in treatment of comminuted fracture of lateral half of the clavicle in adult female.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

. Lateral clavicle fracture lead to sever pain and affect on shoulder movement . This prosthesis will compensate the lost part of the clavicle due to fracture to return the patient to the daily living activity without pain.

This prosthesis will reconstruct the missed part of the clavicle.

Study Type

Interventional

Enrollment (Actual)

1

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
      • Cairo, Egypt, 11431
        • Alkasr alini 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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female has right lateral part comminuted fracture clavicle .

Exclusion Criteria:

  • Male patient
  • Cancer bone patient.
  • Pregnant
  • Left lateral part comminuted fracture clavicle

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: observational
orthopaedic Surgery to fix lateral half prosthesis for clavicle
Procedure: Surgery to fix lateral half prosthesis for clavicle
Surgery to fix lateral half prosthesis for clavicle
Other Names:
  • surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT scan
Time Frame: 1 Day
CT scan to determine the status and position of the prosthesis
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT scan
Time Frame: 6 month
CT scan to determine the status and position of the prosthesis
6 month
Pain intensity measurements: Visual analogue scale
Time Frame: 6 month
Visual analogue scale from 0 to 10 , 0 is no pain and 10 unbearable pain
6 month
American shoulder and elbow surgeons score Special Score for shoulder pain and function.
Time Frame: 6 month

The American shoulder and elbow surgeons score is a composite instrument, requiring both a physician assessment and a patient-completed portion.

. This includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

Intensity of pain: 0; Putting on a coat is not difficult; Sleeping on the affected side is not difficult; Washing my back/doing up my bra is not difficult; Managing toiletting is not difficult; Combing my hair is not difficult; Reaching a high shelf is not difficult; Lifting 10lbs. (4.5kg) above my shoulder is not difficult; Throwing a ball overhand is not difficult; Doing my usual work is not difficult; Doing my usual sport/leisure activity is not difficult; It means good shoulder.
6 month

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Sahar A Abdalbary, ph.D.

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)

August 5, 2018

Primary Completion (ACTUAL)

September 1, 2019

Study Completion (ACTUAL)

November 18, 2019

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (ACTUAL)

July 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cairo University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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