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

Stability of Clavicular Fractures Within the First 3 Weeks Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02089282
• Other study ID #: SJ-369
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2014
• Last updated: March 14, 2014
• Start date: March 2014

Study information

• Verified date: March 2014
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stability of Clavicular Fractures Within the First 3 Weeks

Intervention

Device:
• Ultrasound

Locations

Country	Name	City	State
Denmark	Holbæk sygehus	Holbæk	Vest-sjælland

Sponsors (2)

Lead Sponsor	Collaborator
Holbaek Sygehus	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Constant score		21 days	No
Primary	Change in clavicular length	The dynamic testing of clavicular length and when or which fracures that are stabile.	3 weeks	No
Secondary	Oxford shoulder score		21 days	No