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Clavicular Shortening Post-fracture - Does it Change? - a Prospective Study of 70 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089282
Recruitment Status : Unknown
Verified March 2014 by Holbaek Sygehus.
Recruitment status was:  Recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Holbaek Sygehus

Brief Summary:
In an attempt to answer if clavicular length changes after a fracture e.g. that any shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using a novel ultrasound method.

Condition or disease Intervention/treatment
Stability of Clavicular Fractures Within the First 3 Weeks Device: Ultrasound

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 21 Days
Study Start Date : March 2014
Estimated Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
Clavicle fractures Device: Ultrasound



Primary Outcome Measures :
  1. Change in clavicular length [ Time Frame: 3 weeks ]
    The dynamic testing of clavicular length and when or which fracures that are stabile.


Secondary Outcome Measures :
  1. Oxford shoulder score [ Time Frame: 21 days ]

Other Outcome Measures:
  1. Constant score [ Time Frame: 21 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Clavicular fractures
Criteria

Inclusion Criteria:

All patients who sustain a displaced medial, mid and lateral clavicle fracture from March 2014 to August 2015 referred from Slagelse and Holbæk emergency departments are eligible. The last patients are seen end of mid-July 2015 given the 21 days of follow up.

Exclusion Criteria:

Patients that have bilateral clavicle fractures and/or prior operations involving the clavicle are excluded. Malignant diagnoses are excluded.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089282


Locations
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Denmark
Holbæk sygehus Recruiting
Holbæk, Vest-sjælland, Denmark, 4300
Contact: Anders Thorsmark Høj, MD    + 45 5948000      
Contact: Anders Thorsmark Høj, MD    +45 59484000    athh@regionsjaelland.dk   
Principal Investigator: Anders Thorsmark Høj, MD         
Sponsors and Collaborators
Holbaek Sygehus
Odense University Hospital
Additional Information:

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Responsible Party: Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT02089282    
Other Study ID Numbers: SJ-369
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries