- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05190887
What do Patients Expect After Scaphoid Fractures?
January 12, 2022 updated by: Ali Lari, Kuwait Institute for Medical Specialization
This study will assess patients expectations pre-op and assess their views on their outcome at one year follow up
Study Overview
Status
Recruiting
Conditions
Detailed Description
Using Trauma expectation factor and trauma outcome measure questionnaire. At fracture time and at one year post fracture
Analyse according to age, sex, fracture pattern, type of intervention
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kuwait City, Kuwait, 00000
- Recruiting
- Alrazi orthopedic hospital
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Contact:
- Ali Lari, MB BCh BAO NUI RCSI
- Phone Number: +965 66428328
- Email: dr.alilari@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults with scaphoid fracture
Description
Inclusion Criteria:
- Confirmed diagnosis of a scaphoid fracture
- Age > 18
- Consent for one year follow up
Exclusion Criteria:
- Age <18
- Polytrauma (Multiple systems/ Multiple fractures)
- Ipsilateral fractures of the upper limb that may become distracting or affect rehabilitation
- Delayed presentation with higher risk of non-union or avascular necrosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient expectations after scaphoid fractures
Time Frame: 1 Year
|
Trauma Expectation Factor (TEF) questionnaire will be used at the time of injury - followed by the Trauma Outcome Measure (TOM) questionnaire at 1 - year post injury.
- Together = TEFTOM.
A higher TEF score indicates higher expectations of recovery, while a lower indicated poor expectations.
Discrepancy between the two scores demonstrate poor correlation between what the patient expects and what the outcome is.
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Anticipated)
April 1, 2022
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
December 4, 2021
First Submitted That Met QC Criteria
January 12, 2022
First Posted (Actual)
January 13, 2022
Study Record Updates
Last Update Posted (Actual)
January 13, 2022
Last Update Submitted That Met QC Criteria
January 12, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- KuwaitIMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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