Preoperative Immunonutrition in Patients Undergoing Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-16

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthrosis; Spine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Supplemented patients

Group Type EXPERIMENTAL

Immuno-nutrition

Intervention Type DIETARY_SUPPLEMENT

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.

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No