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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 August 2016 |
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Main ID: |
NCT02857439 |
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Date of registration:
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29/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial
CASH |
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Scientific title:
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Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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280 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02857439 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Robert Jan Derksen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Zaans Medisch Centrum |
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Name:
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Kim Rijsbergen, BSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Robert Jan Derksen, MD |
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Address:
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Telephone:
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Email:
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Derksen.R@zaansmc.nl |
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Affiliation:
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Name:
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Robert Jan Derksen, MD |
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Address:
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Telephone:
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Email:
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Derksen.R@zaansmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Trauma
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Intervention(s)
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Other: Standard diagnostic item list
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Primary Outcome(s)
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Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form.
[Time Frame: An average of 12 to 18 months]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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CASH Zaansmc
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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