NCT05864833

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

January 21, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

May 9, 2023

Last Update Submit

December 5, 2024

Conditions

Orthopedic DisorderMetabolism and Nutrition Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥55
  • Male and female gender
  • Major elective orthopedic surgery (hip, knee, spinal)
  • Signature of the informed consent

You may not qualify if:

  • Inability to follow the study protocol
  • Neuropsychiatric disease, developmental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Milan, Italy

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesNutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Matteo Briguglio

    IRCCS Istituto Ortopedico Galeazzi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

January 21, 2024

Primary Completion

October 3, 2024

Study Completion

October 3, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations

IT(1)