ExpectationsNCT05190887
What do Patients Expect After Scaphoid Fractures?
An observational study of Expectations, run by Kuwait Institute for Medical Specialization at 1 site in Kuwait.
Trial summary
This study will assess patients expectations pre-op and assess their views on their outcome at one year follow up Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Expectations
- How many people
- 100 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Apr 2021to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with scaphoid fracture
Who may be able to join
- Confirmed diagnosis of a scaphoid fracture
- Age > 18
- Consent for one year follow up
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
AlRazi Orthopedic Hospital
Kuwait City, 00000
Ali Lari, MB BCh BAO NUI RCSI, +965 66428328, dr.alilari@gmail.com
About this study
This study will assess patients expectations pre-op and assess their views on their outcome at one year follow up
Read the 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
- Conditions
- Expectations
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient expectations after scaphoid fractures
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Apr 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExpectationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuwait Institute for Medical Specialization
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ali Lari, Kuwait Institute for Medical Specialization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190887
- Sponsor's protocol ID
- KuwaitIMS
- Status last verified
- Jan 2022
- First submitted
- 4 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What do Patients Expect After Scaphoid Fractures?
- ClinicalTrials.gov ID
- NCT05190887
- Acronym / sponsor ID
- KuwaitIMS
- Conditions
- Expectations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kuwait Institute for Medical SpecializationOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess patients expectations pre-op and assess their views on their outcome at one year follow up
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with scaphoid fracture
Key inclusion criteria (3 listed)
- Confirmed diagnosis of a scaphoid fracture
- Age > 18
- Consent for one year follow up
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Expectations, run by Kuwait Institute for Medical Specialization at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient expectations after scaphoid fractures (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.