Customized Polyamide Prosthesis. for Mid Shaft Clavicle Fracture

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05261308
• Collaborator: (none)
• Enrollment: 1
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 53.1
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Treatment Adherence and Compliance	Other: new prosthesis	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: New Polyamide Prosthesis for Treatment of Non-union Mid Shaft Clavicle Fracture: A Case Report
• Actual Study Start Date: Mar 16, 2018
• Actual Primary Completion Date: Aug 14, 2018
• Anticipated Study Completion Date: Aug 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: prosthesis The polyamide prosthesis	Other: new prosthesis; Operation to fix the new prosthesis

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• fracture midshaft clavicle

Exclusion Criteria:

• normal clavicle

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahar Abdalbary	Cairo	Select State/province	Egypt	11431
2	Sahar	Cairo		Egypt	11431

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Sahar Abdalbary, professor, Nahda University, Faculty of Physical Therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sahar Ahmed Abdalbary, Associate professor, Cairo University
• ClinicalTrials.gov Identifier: NCT05261308
• Other Study ID Numbers: polyamide
• First Posted: Mar 2, 2022
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Aug 16, 2022