NCT03577678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 5, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

June 13, 2018

Last Update Submit

August 2, 2021

Conditions

Bone FractureBone LesionClavicle Fracture

Keywords

Comminuted lateral clavicle fracture , New prosthesis,

Outcome Measures

Primary Outcomes (1)

  • CT scan

    CT scan to determine the status and position of the prosthesis

    1 Day

Secondary Outcomes (3)

  • CT scan

    6 month

  • Pain intensity measurements: Visual analogue scale

    6 month

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

    6 month

Study Arms (1)

observational

EXPERIMENTAL

orthopaedic Surgery to fix lateral half prosthesis for clavicle

Procedure: Surgery to fix lateral half prosthesis for clavicle

Interventions

Surgery to fix lateral half prosthesis for claviclePROCEDURE

Surgery to fix lateral half prosthesis for clavicle

Also known as: surgery
observational

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female has right lateral part comminuted fracture clavicle .

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alkasr alini hospital

Cairo, 11431, Egypt

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Sahar A Abdalbary, ph.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Surgery was made to fix the new prosthesis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator.

Study Record Dates

First Submitted

June 13, 2018

First Posted

July 5, 2018

Study Start

August 5, 2018

Primary Completion

September 1, 2019

Study Completion

November 18, 2019

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)