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Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial (CASH)

Primary Purpose

Trauma

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Standard diagnostic item list
Sponsored by
Zaans Medisch Centrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Trauma focused on measuring Trauma of the shoulder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged18-65 years
  • Trauma <48h

Exclusion Criteria:

  • 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)

Sites / Locations

  • Zaans Medisch CentrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

MD as first examiner

Triage nurse as first examiner

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2016
Last Updated
August 2, 2016
Sponsor
Zaans Medisch Centrum
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1. Study Identification

Unique Protocol Identification Number
NCT02857439
Brief Title
Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial
Acronym
CASH
Official Title
Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zaans Medisch Centrum

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The CASH (Clavicle-AC-Joint-Sub-capital-Humerus) trial is designed as a cross sectional interobserver study. It will randomize between first examiner of the patient to determine applicability for triage use and use a list of 19 criteria to determine a clinical decision rule for significant shoulder injuries. Method/intervention After admittance to the ED, all consecutive shoulder injury patients will be assessed for eligibility in the study. After informed consent is given, the patient will be randomized for first observer (ED physician or triage nurse) to be examined, which means they will be assessed in duplo. The patient will be examined by means of a score form, which contains 19 different diagnostic criteria. The criteria are grouped: anamnesis, inspection, palpation and pain/range of motion(ROM). After completing the list, patients will get a full set of shoulder x-rays: shoulder AP- and axial-view, and clavicle AP and 30' cranio-caudal view. The trial participation for the patient will be completed at this point and final diagnosis and treatment are provided by the ED physician according to his/her own findings and interpretation of the radiographs. For the study, the radiographs will be reassessed by one consultant radiologist specialized in skeletal trauma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
Trauma of the shoulder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MD as first examiner
Arm Type
Other
Arm Description
Patients will be examined according to a standardized physical examination item list
Arm Title
Triage nurse as first examiner
Arm Type
Other
Arm Description
Patients will be examined according to a standardized physical examination item list
Intervention Type
Other
Intervention Name(s)
Standard diagnostic item list
Intervention Description
All consecutive patients are assessed by both examiners, according to a standardized physical examination item list.
Primary Outcome Measure Information:
Title
Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form.
Time Frame
An average of 12 to 18 months
Secondary Outcome Measure Information:
Title
Interobserver agreement for each clinical variable between both observers determined with the Cohen's kappa coefficient
Time Frame
An average of 12 to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged18-65 years Trauma <48h Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Jan Derksen, MD
Email
Derksen.R@zaansmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Rijsbergen, BSc
Email
Rijsbergen.K@zaansmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Rijsbergen, BSc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Jan Derksen, MD
Organizational Affiliation
Zaans Medisch Centrum
Official's Role
Study Director
Facility Information:
Facility Name
Zaans Medisch Centrum
City
Zaandam
State/Province
Noord-Holland
ZIP/Postal Code
1502 DV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Jan Derksen, MD
Email
Derksen.R@zaansmc.nl
First Name & Middle Initial & Last Name & Degree
Kim Rijsbergen, BSc
Email
Rijsbergen.K@zaansmc.nl
First Name & Middle Initial & Last Name & Degree
Kim Rijsbergen, BSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
1554175
Citation
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.
Results Reference
background
PubMed Identifier
12595378
Citation
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.
Results Reference
background
PubMed Identifier
7663253
Citation
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.
Results Reference
background

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Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial

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