NCT02089282

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

March 14, 2014

Last Update Submit

March 14, 2014

Conditions

Stability of Clavicular Fractures Within the First 3 Weeks

Outcome Measures

Primary Outcomes (1)

  • Change in clavicular length

    The dynamic testing of clavicular length and when or which fracures that are stabile.

    3 weeks

Secondary Outcomes (1)

  • Oxford shoulder score

    21 days

Other Outcomes (1)

  • Constant score

    21 days

Study Arms (1)

Clavicle fractures

Device: Ultrasound

Interventions

UltrasoundDEVICE
Clavicle fractures

Eligibility Criteria

Age17 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clavicular fractures

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holbæk sygehus

Holbæk, Vest-sjælland, 4300, Denmark

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
21 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 17, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

DK(1)