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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05864833
Other study ID # METOS (PI: M Briguglio)
Secondary ID L4176
Status Recruiting
Phase
First received
Last updated
Start date September 6, 2023
Est. completion date June 1, 2024

Study information

Verified date May 2023
Source Istituto Ortopedico Galeazzi
Contact Elena Cittera
Phone 00390283502224
Email elena.cittera@grupposandonato.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective observational study evaluates changes in resting basal metabolic rate in 51 adult patients undergoing elective major orthopedic surgery (hip, knee, or spine surgery).


Recruitment information / eligibility

Status Recruiting
Enrollment 51
Est. completion date June 1, 2024
Est. primary completion date September 12, 2023
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria: - Age =55 - Male and female gender - Major elective orthopedic surgery (hip, knee, spinal) - Signature of the informed consent Exclusion Criteria: - Inability to follow the study protocol - Neuropsychiatric disease, developmental disorders

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in basal energy expenditure Changes in the basal metabolic rate (kcal) evaluated before and after major orthopedic surgery Day before surgery and first day after surgery
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