- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05864833
METabolism After Orthopedic Surgery
July 4, 2023 updated by: Istituto Ortopedico Galeazzi
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
Recruiting
Study Type
Observational
Enrollment (Estimated)
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 Contact
- Name: Elena Cittera
- Phone Number: 00390283502224
- Email: elena.cittera@grupposandonato.it
Study Locations
-
-
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Milan, Italy
- Recruiting
- IRCCS Istituto Ortopedico Galeazzi
-
Contact:
- Elena Cittera
- Phone Number: 00390283502224
- Email: elena.cittera@grupposandonato.it
-
Principal Investigator:
- Matteo Briguglio
-
-
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
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 (Estimated)
September 6, 2023
Primary Completion (Estimated)
September 12, 2023
Study Completion (Estimated)
June 1, 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 (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 4, 2023
Last Verified
May 1, 2023
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
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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