NCT05162521

Brief Summary

The study will prospectively follow patients with lower limb fractures to assess changes in weight after injury

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
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

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 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

December 5, 2021

Last Update Submit

December 5, 2021

Conditions

Fracture

Outcome Measures

Primary Outcomes (1)

  • The impact of lower limb fractures on body mass index (BMI)

    Assessing BMI at different time intervals after lower limb fractures

    Change in weight over one year at different time intervals

Eligibility Criteria

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

Adults with lower limb fractures

You may qualify if:

  • Adults with lower limb fractures

You may not qualify if:

  • Polytrauma
  • Upper limb fractures
  • No consent
  • Lack of follow up
  • Patients opting for weight management treatments
  • Patients with pre-existing mobility status impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlRazi Orthopedic Hospital

Kuwait City, 00000, Kuwait

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

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

Study Record Dates

First Submitted

December 5, 2021

First Posted

December 17, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

December 17, 2021

Record last verified: 2021-12

Locations

KU(1)