FractureNCT05162521
The Impact of Lower Limb Fractures on Body Mass Index (BMI)
An observational study of Fracture, run by Kuwait Institute for Medical Specialization at 1 site in Kuwait.
Trial summary
The study will prospectively follow patients with lower limb fractures to assess changes in weight after injury Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture
- How many people
- 400 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Apr 2021to 1 May 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
- Adult, Older adult
Study population: Adults with lower limb fractures
Who may be able to join
- Adults with lower limb fractures
Who cannot join
- Polytrauma
- Upper limb fractures
- No consent
- Lack of follow up
- Patients opting for weight management treatments
- Patients with pre-existing mobility status impairment
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
The study will prospectively follow patients with lower limb fractures to assess changes in weight after injury
- Conditions
- Fracture
- Medical subject headings
- Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of lower limb fractures on body mass index (BMI)
Assessing BMI at different time intervals after lower limb fractures
Measured: Change in weight over one year at different time intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies 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
- 400 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
- NCT05162521
- Sponsor's protocol ID
- KuwaitIMS2
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 17 Dec 2021
- 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 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lower Limb Fractures on Body Mass Index (BMI)
- ClinicalTrials.gov ID
- NCT05162521
- Acronym / sponsor ID
- KuwaitIMS2
- Conditions
- Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kuwait Institute for Medical SpecializationOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 17 Dec 2021 (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.
The study will prospectively follow patients with lower limb fractures to assess changes in weight after injury
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with lower limb fractures
Key inclusion criteria (1 listed)
- Adults with lower limb fractures
Key exclusion criteria (6 listed)
- Polytrauma
- Upper limb fractures
- No consent
- Lack of follow up
- Patients opting for weight management treatments
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- 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 Fracture, 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 1 inclusion and 6 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 17 Dec 2021. 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?
The impact of lower limb fractures on body mass index (BMI) (time frame: Change in weight over one year at different time intervals). 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 17 Dec 2021.