- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02857439
Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial (CASH)
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.
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert Jan Derksen, MD
- Email: Derksen.R@zaansmc.nl
Study Contact Backup
- Name: Kim Rijsbergen, BSc
- Email: Rijsbergen.K@zaansmc.nl
Study Locations
-
-
Noord-Holland
-
Zaandam, Noord-Holland, Netherlands, 1502 DV
- Recruiting
- Zaans Medisch Centrum
-
Contact:
- Robert Jan Derksen, MD
- Email: Derksen.R@zaansmc.nl
-
Contact:
- Kim Rijsbergen, BSc
- Email: Rijsbergen.K@zaansmc.nl
-
Principal Investigator:
- Kim Rijsbergen, BSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: MD as first examiner
Patients will be examined according to a standardized physical examination item list
|
All consecutive patients are assessed by both examiners, according to a standardized physical examination item list.
|
Other: Triage nurse as first examiner
Patients will be examined according to a standardized physical examination item list
|
All consecutive patients are assessed by both examiners, according to a standardized physical examination item list.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form.
Time Frame: An average of 12 to 18 months
|
An average of 12 to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
An average of 12 to 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kim Rijsbergen, BSc
- Study Director: Robert Jan Derksen, MD, Zaans Medisch Centrum
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASH Zaansmc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma
-
Humacyte, Inc.Active, not recruitingTrauma | Trauma Injury | Trauma, Multiple | Trauma BluntUkraine
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedTrauma Injury | Trauma, MultipleTurkey
-
Wonju Severance Christian HospitalNational Research Foundation of KoreaRecruitingTrauma Injury | Trauma, MultipleKorea, Republic of
-
Rabin Medical CenterIsraeli Ministry of SecurityUnknown
-
University Hospital, AngersRecruiting
-
Chang, Steve S., M.D.Santa Barbara Cottage Hospital; Accumetrics, Inc.CompletedHead Injury Trauma BluntUnited States
-
Oslo University HospitalUniversity of Oslo; Sunnaas Rehabilitation Hospital; South-Eastern Norway Regional...RecruitingTrauma Injury | Trauma, Multiple | PolytraumaNorway
-
Assistance Publique - Hôpitaux de ParisFrancophone Pediatric Resuscitation and Emergency Group (GFRUP)Completed
-
Fundacion Clinica Valle del LiliUniversity of Pittsburgh; Hospital Universitario del Valle Evaristo GarciaRecruitingTrauma | Trauma Injury | Trauma, MultipleColombia
Clinical Trials on Standard diagnostic item list
-
Korea Health Industry Development InstituteCompletedGeneralized Anxiety DisorderKorea, Republic of
-
Hôpital le VinatierCompleted
-
Korea Health Industry Development InstituteUnknown
-
Korea Health Industry Development InstituteCompletedHwa-byung (Disorder)Korea, Republic of
-
Lisa J. FrymanTerminatedTrauma Patients Requiring Physical RehabilitationUnited States
-
University Hospital MuensterUnknownCoronary Artery Disease | Chronic Kidney DiseaseGermany
-
Sun Yat-sen UniversityCompletedDiagnositic Efficacy of Deep Convolutional Neural Network in Differentiation of Glaucoma Visual Field From Non-glaucoma Visual FieldChina
-
Medibio LimitedCompleted
-
Medtronic Cardiac Rhythm and Heart FailureTerminated
-
Ryerson UniversityCanadian Institutes of Health Research (CIHR); Simon Fraser University; University...Completed