New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle

Bone Fracture Clinical Trial

— Prosthesis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577678
• Other study ID #: Cairo University Hospital
• Status: Completed
• Phase: N/A
• Start date: August 5, 2018
• Est. completion date: November 18, 2019

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 18, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Female has right lateral part comminuted fracture clavicle .

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bone Fracture
• Bone Lesion
• Clavicle Fracture
• Fractures, Bone
• Fractures, Comminuted

Intervention

Procedure:
• Surgery to fix lateral half prosthesis for clavicle
Surgery to fix lateral half prosthesis for clavicle

Locations

Country	Name	City	State
Egypt	Alkasr alini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT scan	CT scan to determine the status and position of the prosthesis	1 Day
Secondary	CT scan	CT scan to determine the status and position of the prosthesis	6 month
Secondary	Pain intensity measurements: Visual analogue scale	Visual analogue scale from 0 to 10 , 0 is no pain and 10 unbearable pain	6 month
Secondary	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.	6 month