Preoperative Immunonutrition in Patients Undergoing Spine Surgery

Immunonnutrition in Spine Surgery to Improve Patient's Outcome: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Arthrosis; Spine
• Intervention / Treatment: Dietary supplement: Immuno-nutrition

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Cittera; Phone Number: 00390283502224; Email: elena.cittera@grupposandonato.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • IRCCS Istituto Ortopedico Galeazzi
    • Contact: Elena Cittera; Phone Number: 00390283502224; Email: elena.cittera@grupposandonato.it
    • Principal Investigator: Matteo Briguglio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• male and female sex, of all ethnicities, aged over 60
• arthrodesis involving ≥ 6 vertebrae
• American Society of Anesthesiology (ASA) risk: 1, 2, or 3
• Absence of neurological or psychiatric disorders
• Signing of informed consent and consent to collaborate in all study procedures
• Patients who meet the clinical requirements to undergo their first spinal surgery

Exclusion Criteria:

• American Society of Anesthesiology (ASA) risk: 4
• No cervical arthrodesis
• Diagnosis of neurological or psychiatric disorders
• Revisions
• Therapy with other supplements at the time of the first visit 0
• Known allergy or adverse food reactions
• Chronic inflammatory or autoimmune diseases (e.g. rheumatoid arthritis)
• Gastrointestinal disorders
• Conditions that do not allow to undergo surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
Experimental: Supplemented patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amelioration of functions evaluated through the Oswestry Disability Index (ODI)	3 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi
• Investigators: Principal Investigator: Matteo Briguglio, IRCCS Istituto Ortopedico Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: ORTHOPACT (PI: M Briguglio); L4144 (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