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Preoperative Immunonutrition in Patients Undergoing Spine Surgery

NCT05372289 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-05-06

No results posted yet for this study

Summary

A malnutritional status is known to be associated with altered immune function, reduced function, and worsen outcomes after orthopedic surgery. Medical and surgical complications are not uncommon in Orthopedics and infection rates are potentially life-threatening complications, with the highest morbidity, mortality, and healthcare costs. Most patients undergoing orthopedic surgery are elderly, malnourished, osteosarcopenic, sedentary, anemic, and suffer from low levels of vitamin D. A mono-nutrient supplement may be not sufficient for supporting the arthrodesis techniques, which are invasive open surgeries procedures with significant blood losses and the need of transfusions. In this therapeutic area, immuno-nutrition has been used in spine surgery, with the reduction of complications, revisions, and readmissions. In addition, prosthetic surgery outcomes have been observed to ameliorate by using this nutritional support. Therefore, preoperative oral immuno-nutrition therapy may be applied in older adults undergoing spine surgery to improve patients' outcomes and reduce complications.

This is a randomized, controlled, open-label, 2-arm non-parallel-group, single-center interventional study to assess the efficacy of an immuno-nutrition therapy vs. hospital standard of care in spine surgery to improve patients' outcomes. This is a single primary endpoint study. A total of 136 patients from IRCCS Orthopedic Institute Galeazzi in Italy will be recruited and assigned in a 1:1 ratio to the treatment arm.

Conditions

  • Arthrosis; Spine

Interventions

DIETARY_SUPPLEMENT

Immuno-nutrition

The experimental group of 68 older adults will be subjected to a preoperative immuno-nutrition for 30 days prior to surgery and up to 3 days after surgery. The oral feed provides energy, omega-3 fatty acids, arginine, nucleotides, and soluble fibre.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Matteo Briguglio · IRCCS Istituto Ortopedico Galeazzi

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05372289 on ClinicalTrials.gov