Customized Polyamide Prosthesis. for Mid Shaft Clavicle Fracture

Treatment Adherence and Compliance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05261308
• Other study ID #: polyamide
• Status: Completed
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: April 18, 2022

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 18, 2022
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• fracture midshaft clavicle

Exclusion Criteria:

• normal clavicle

Related Conditions & MeSH terms

• Treatment Adherence and Compliance

Intervention

Other:
• new prosthesis
Operation to fix the new prosthesis

Locations

Country	Name	City	State
Egypt	Sahar	Cairo
Egypt	Sahar Abdalbary	Cairo	Select State/province

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American shoulder and elbow surgeons score Special Score for shoulder pain and function	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	after 2 and half years