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New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle (Prosthesis)

Primary Purpose

Bone Fracture, Bone Lesion, Clavicle Fracture

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Surgery to fix lateral half prosthesis for clavicle
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bone Fracture focused on measuring Comminuted lateral clavicle fracture , New prosthesis,

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female has right lateral part comminuted fracture clavicle .

Exclusion Criteria:

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

Sites / Locations

  • Alkasr alini hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

observational

Arm Description

orthopaedic Surgery to fix lateral half prosthesis for clavicle

Outcomes

Primary Outcome Measures

CT scan
CT scan to determine the status and position of the prosthesis

Secondary Outcome Measures

CT scan
CT scan to determine the status and position of the prosthesis
Pain intensity measurements: Visual analogue scale
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.
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.

Full Information

First Posted
June 13, 2018
Last Updated
August 2, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03577678
Brief Title
New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fracture, Bone Lesion, Clavicle Fracture
Keywords
Comminuted lateral clavicle fracture , New prosthesis,

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Surgery was made to fix the new prosthesis
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
observational
Arm Type
Experimental
Arm Description
orthopaedic Surgery to fix lateral half prosthesis for clavicle
Intervention Type
Procedure
Intervention Name(s)
Surgery to fix lateral half prosthesis for clavicle
Other Intervention Name(s)
surgery
Intervention Description
Surgery to fix lateral half prosthesis for clavicle
Primary Outcome Measure Information:
Title
CT scan
Description
CT scan to determine the status and position of the prosthesis
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
CT scan
Description
CT scan to determine the status and position of the prosthesis
Time Frame
6 month
Title
Pain intensity measurements: Visual analogue scale
Description
Visual analogue scale from 0 to 10 , 0 is no pain and 10 unbearable pain
Time Frame
6 month
Title
American shoulder and elbow surgeons score Special Score for shoulder pain and function.
Description
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.
Time Frame
6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female has right lateral part comminuted fracture clavicle . Exclusion Criteria: Male patient Cancer bone patient. Pregnant Left lateral part comminuted fracture clavicle
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar A Abdalbary, ph.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alkasr alini hospital
City
Cairo
ZIP/Postal Code
11431
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle

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