- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05162521
The Impact of Lower Limb Fractures on Body Mass Index (BMI)
December 5, 2021 updated by: Ali Lari, Kuwait Institute for Medical Specialization
The study will prospectively follow patients with lower limb fractures to assess changes in weight after injury
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
400
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, 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
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults with lower limb fractures
Description
Inclusion Criteria:
- Adults with lower limb fractures
Exclusion Criteria:
- Polytrauma
- Upper limb fractures
- No consent
- Lack of follow up
- Patients opting for weight management treatments
- Patients with pre-existing mobility status impairment
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 |
|---|---|---|
|
The impact of lower limb fractures on body mass index (BMI)
Time Frame: Change in weight over one year at different time intervals
|
Assessing BMI at different time intervals after lower limb fractures
|
Change in weight over one year at different time intervals
|
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)
May 1, 2022
Study Registration Dates
First Submitted
December 5, 2021
First Submitted That Met QC Criteria
December 5, 2021
First Posted (Actual)
December 17, 2021
Study Record Updates
Last Update Posted (Actual)
December 17, 2021
Last Update Submitted That Met QC Criteria
December 5, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KuwaitIMS2
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.