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METabolism After Orthopedic Surgery

Sponsor
Istituto Ortopedico Galeazzi (Other)
Overall Status
Recruiting
CT.gov ID
NCT05864833
Collaborator
(none)
51
Enrollment
1
Location
11.9
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    51 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of Energy Metabolism Modifications in Patients Undergoing Orthopedic Surgery
    Anticipated Study Start Date :
    Jun 6, 2023
    Anticipated Primary Completion Date :
    Jun 12, 2023
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Changes in basal energy expenditure [Day before surgery and first day after surgery]

      Changes in the basal metabolic rate (kcal) evaluated before and after major orthopedic surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Istituto Ortopedico Galeazzi Milan Italy

    Sponsors and Collaborators

    • Istituto Ortopedico Galeazzi

    Investigators

    • Principal Investigator: Matteo Briguglio, IRCCS Istituto Ortopedico Galeazzi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Ortopedico Galeazzi
    ClinicalTrials.gov Identifier:
    NCT05864833
    Other Study ID Numbers:
    • METOS (PI: M Briguglio)
    • L4176
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 18, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Musculoskeletal Diseases
    Nutrition Disorders
    Disease

    Study Results

    No Results Posted as of May 18, 2023