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OpenTrials
Completed

NCT Number: NCT05261308

Customized Polyamide Prosthesis. for Mid Shaft Clavicle Fracture

Herein we describe the management of a patient who presented with progressive brachial plexopathy following the initial nonoperative management of a mid shaft clavicular fracture by using 3 D customized polyamide prosthesis.

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sahar Abdalbary, Cairo, Select State/province, Egypt

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About this study

we made surgery to fix the new polyamide prosthesies in the clavicle.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • fracture midshaft clavicle

Exclusion criteria

  • normal clavicle

Treatment and study plan

new prosthesis

Other

Operation to fix the new prosthesis

Primary outcomes

  1. American shoulder and elbow surgeons score Special Score for shoulder pain and function

    Time frame: after 2 and half years

    American shoulder and elbow surgeons score Special Score for shoulder pain and function.

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

New Polyamide Prosthesis for Treatment of Non-union Mid Shaft Clavicle Fracture: A Case Report

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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