NCT06107959

Brief Summary

This project is intended to determine the magnitude and duration of RMR changes in patients receiving orthopedic surgery. The result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress82%
Oct 2023Dec 2026

Study Start

First participant enrolled

October 10, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

October 12, 2023

Last Update Submit

July 8, 2025

Conditions

Metabolism; Disorder, PostproceduralResting Metabolic RatePost Operative Nutrition

Outcome Measures

Primary Outcomes (2)

  • To determine the magnitude of the change in RMR of patients receiving orthopedic surgery.

    RMR = (9.99 X actual weight\*)+ (6.25 X height\*) - (4.92 X age) - 161\*use weight in kilograms (kilogram), height in centimeters (cm).

    12 weeks

  • To observe the amount of time it takes the RMR to return to baseline.

    calculation in number of weeks

    12 weeks

Study Arms (2)

Male

50 male subjects undergoing orthopedic surgery.

Other: Pre-surgical nutrition, hydration, RMR, and body composition assessmentsOther: Post-surgical nutrition, hydration, RMR and body composition assessments

Female

50 female subjects undergoing orthopedic surgery

Other: Pre-surgical nutrition, hydration, RMR, and body composition assessmentsOther: Post-surgical nutrition, hydration, RMR and body composition assessments

Interventions

Pre-surgical nutrition, hydration, RMR, and body composition assessmentsOTHER

Urine sample, InBody device platform, Metabolic cart with hood to collect RMR.

FemaleMale
Post-surgical nutrition, hydration, RMR and body composition assessmentsOTHER

Same as pre-surgical tests at 1 week, 3 weeks, 6 weeks, and 12 weeks follow up time points.

FemaleMale

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects will be over the age of 15 years old undergoing elective orthopedic surgery at KU Medical Center.

You may qualify if:

  • Any individual over 15 undergoing an orthopedic surgery.

You may not qualify if:

  • Pregnant female
  • \< 15 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Publications (6)

  • Braga M, Baccari P, Scaccabarozzi S, Fiacco E, Radaelli G, Gallus G, DiPalo S, DiCarlo V, Cristallo M. Prognostic role of preoperative nutritional and immunological assessment in the surgical patient. JPEN J Parenter Enteral Nutr. 1988 Mar-Apr;12(2):138-42. doi: 10.1177/0148607188012002138.

    PMID: 3283387BACKGROUND

  • Hu SS, Fontaine F, Kelly B, Bradford DS. Nutritional depletion in staged spinal reconstructive surgery. The effect of total parenteral nutrition. Spine (Phila Pa 1976). 1998 Jun 15;23(12):1401-5. doi: 10.1097/00007632-199806150-00019.

    PMID: 9654632BACKGROUND

  • Lenke LG, Bridwell KH, Blanke K, Baldus C. Prospective analysis of nutritional status normalization after spinal reconstructive surgery. Spine (Phila Pa 1976). 1995 Jun 15;20(12):1359-67.

    PMID: 7676333BACKGROUND

  • Ljungqvist O, Soop M, Hedstrom M. Why metabolism matters in elective orthopedic surgery: a review. Acta Orthop. 2007 Oct;78(5):610-5. doi: 10.1080/17453670710014293. No abstract available.

    PMID: 17966019BACKGROUND

  • Malone DL, Genuit T, Tracy JK, Gannon C, Napolitano LM. Surgical site infections: reanalysis of risk factors. J Surg Res. 2002 Mar;103(1):89-95. doi: 10.1006/jsre.2001.6343.

    PMID: 11855922BACKGROUND

  • McMulkin ML, Ferguson RL. Resting energy expenditure and respiratory quotient in adolescents following spinal fusion surgery. Spine (Phila Pa 1976). 2004 Aug 15;29(16):1831-5. doi: 10.1097/01.brs.0000134564.24874.10.

    PMID: 15303030BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Specific Gravity, hydration assessment in order to complete the body composition test.

Central Study Contacts

Sharon Bradshaw

CONTACT

913-945-6289sbradshaw2@kumc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 30, 2023

Study Start

October 10, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)