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Completed

NCT Number: NCT03577678

New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle

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

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Key information

Conditions

Bone Fracture Bone Lesion Clavicle Fracture Fractures, Bone Wounds and Injuries

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alkasr alini hospital

Cairo, 11431, Egypt

About this study

. 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female has right lateral part comminuted fracture clavicle .

Exclusion criteria

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

Treatment and study plan

Surgery to fix lateral half prosthesis for clavicle

Procedure

Surgery to fix lateral half prosthesis for clavicle

Other names: surgery

Primary outcomes

  1. CT scan

    Time frame: 1 Day

    CT scan to determine the status and position of the prosthesis

Secondary outcomes

  1. CT scan

    Time frame: 6 month

    CT scan to determine the status and position of the prosthesis

  2. Pain intensity measurements: Visual analogue scale

    Time frame: 6 month

    Visual analogue scale from 0 to 10 , 0 is no pain and 10 unbearable pain

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Acronym: Prosthesis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2018
Registry last updated
Aug 3, 2021

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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