Immuno-nutrition in Spine Surgery

Sponsor

Istituto Ortopedico Galeazzi (Other)

Overall Status

Recruiting

CT.gov ID

NCT05372289

Collaborator

(none)

136

Enrollment

Location

Arms

22.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Arthrosis; Spine	Dietary Supplement: Immuno-nutrition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

In this study, the primary endpoint assessors, who are assessing parameters constituting the primary endpoints, will be masked to the treatment regimen. Any personnel involved with the statistical analysis and interpretation of the data and results will be masked to the treatment regimen until database lock.

Primary Purpose:

Supportive Care

Official Title:

Immuno-nutrition in Spine Surgery to Improve Patient's Outcome: a Randomized Controlled Trial

Actual Study Start Date :

Mar 16, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Standard of care

Arm

Intervention/Treatment

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.

No Intervention: Standard of care

Outcome Measures

Primary Outcome Measures

Amelioration of functions evaluated through the Oswestry Disability Index (ODI) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Istituto Ortopedico Galeazzi	Milan		Italy	20141

Sponsors and Collaborators

Istituto Ortopedico Galeazzi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Ortopedico Galeazzi

ClinicalTrials.gov Identifier:

NCT05372289

Other Study ID Numbers:

ORTHOPACT

First Posted:

May 12, 2022

Last Update Posted:

May 20, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of May 20, 2022