New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle

Not Applicable

Completed

• Conditions: Bone Fracture; Bone Lesion; Clavicle Fracture
• Interventions: Procedure: Surgery to fix lateral half prosthesis for clavicle

• Registration Number: NCT03577678
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-05
• Study Start: 2018-08-05
• Primary Completion: 2019-09-01
• Study Completion: 2019-11-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Female has right lateral part comminuted fracture clavicle .

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
observational	Surgery to fix lateral half prosthesis for clavicle	orthopaedic Surgery to fix lateral half prosthesis for clavicle

Primary Outcome Measures

Name	Time	Method
CT scan	1 Day	CT scan to determine the status and position of the prosthesis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alkasr alini hospital; 🇪🇬 Cairo, Egypt