Clinical trial NCT05372289: Preoperative Immunonutrition in Patients Undergoing Spine Surgery
Official title: Immunonnutrition in Spine Surgery to Improve Patient's Outcome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthrosis; Spine
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 136
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Amelioration of functions evaluated through the Oswestry Disability Index (ODI)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Matteo Briguglio
role: PRINCIPAL_INVESTIGATOR
References: