METabolism After Orthopedic Surgery

December 5, 2024 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study of Energy Metabolism Modifications in Patients Undergoing Orthopedic Surgery

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

51

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

  • Italy
      • Milan, Italy
        • IRCCS Istituto Ortopedico Galeazzi

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults patients undergoing elective major orthopedic surgery, such as hip, knee, or spine surgery.

Description

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 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
Changes in basal energy expenditure
Time Frame: Day before surgery and first day after surgery
Changes in the basal metabolic rate (kcal) evaluated before and after major orthopedic surgery
Day before surgery and first day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Investigators

  • Principal Investigator: Matteo Briguglio, IRCCS Istituto Ortopedico Galeazzi

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)

January 21, 2024

Primary Completion (Actual)

October 3, 2024

Study Completion (Actual)

October 3, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METOS (PI: M Briguglio)
  • L4176 (Other Grant/Funding Number: Italian Ministry of Health)

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

product manufactured in and exported from the U.S.

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.

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