NCT05190887

Brief Summary

This study will assess patients expectations pre-op and assess their views on their outcome at one year follow up

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

December 4, 2021

Last Update Submit

January 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 Year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with scaphoid fracture

You may qualify if:

  • Confirmed diagnosis of a scaphoid fracture
  • Age \> 18
  • Consent for one year follow up

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlRazi Orthopedic Hospital

Kuwait City, 00000, Kuwait

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator: Dr Ali Lari - MB BCh BAO

Study Record Dates

First Submitted

December 4, 2021

First Posted

January 13, 2022

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 13, 2022

Record last verified: 2022-01

Locations