NCT02857439

Brief Summary

What combination of ≤ 6 clinical variables will give the highest specificity for indicating significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%? Although shoulder trauma is a common injury, there is no clinical decision rule to determine the necessity for radiography for these traumas. With this trial the investigators aim to develop such a rule to reduce the amount of radiographs without missing any significant injuries. The primary objective is to compose a set of clinical diagnostic criteria predictive of shoulder fractures or dislocations that would reduce the amount of radiographs without missing any significant injuries. A second objective is to determine if the clinical decision rule is applicable for triage use.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

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

July 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

July 29, 2016

Last Update Submit

August 2, 2016

Conditions

Trauma

Keywords

Trauma of the shoulder

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form.

    An average of 12 to 18 months

Secondary Outcomes (1)

  • Interobserver agreement for each clinical variable between both observers determined with the Cohen's kappa coefficient

    An average of 12 to 18 months

Study Arms (2)

MD as first examiner

OTHER

Patients will be examined according to a standardized physical examination item list

Other: Standard diagnostic item list

Triage nurse as first examiner

OTHER

Patients will be examined according to a standardized physical examination item list

Other: Standard diagnostic item list

Interventions

Standard diagnostic item listOTHER

All consecutive patients are assessed by both examiners, according to a standardized physical examination item list.

MD as first examinerTriage nurse as first examiner

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged18-65 years
  • Trauma \<48h

You may not qualify if:

  • Any prior ipsilateral shoulder surgery.
  • Any diseases of the bones potentially influencing fracturability (osteogenesis imperfecta, osteoporosis, achondroplasia, M. Kahler, chronic (\> 1yr) prednisone use \> 5mg)
  • Any shoulder injury as part of a multi-trauma or high energy trauma (HET) with distractible injuries
  • Any condition that will influence the perception of pain (e.g. alcohol intoxication, psychiatric problems, mental retardation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zaans Medisch Centrum

Zaandam, North Holland, 1502 DV, Netherlands

RECRUITING

Related Publications (3)

  • Stiell IG, Greenberg GH, McKnight RD, Nair RC, McDowell I, Worthington JR. A study to develop clinical decision rules for the use of radiography in acute ankle injuries. Ann Emerg Med. 1992 Apr;21(4):384-90. doi: 10.1016/s0196-0644(05)82656-3.

    PMID: 1554175BACKGROUND

  • Bachmann LM, Kolb E, Koller MT, Steurer J, ter Riet G. Accuracy of Ottawa ankle rules to exclude fractures of the ankle and mid-foot: systematic review. BMJ. 2003 Feb 22;326(7386):417. doi: 10.1136/bmj.326.7386.417.

    PMID: 12595378BACKGROUND

  • Stiell I, Wells G, Laupacis A, Brison R, Verbeek R, Vandemheen K, Naylor CD. Multicentre trial to introduce the Ottawa ankle rules for use of radiography in acute ankle injuries. Multicentre Ankle Rule Study Group. BMJ. 1995 Sep 2;311(7005):594-7. doi: 10.1136/bmj.311.7005.594.

    PMID: 7663253BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Kim Rijsbergen, BSc

    PRINCIPAL INVESTIGATOR

  • Robert Jan Derksen, MD

    Zaans Medisch Centrum

    STUDY DIRECTOR

Central Study Contacts

Robert Jan Derksen, MD

CONTACT

Derksen.R@zaansmc.nl

Kim Rijsbergen, BSc

CONTACT

Rijsbergen.K@zaansmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research intern

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 5, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2018

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations

NL(1)