Preoperative Immunonutrition in Patients Undergoing Spine Surgery

Arthrosis; Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372289
• Other study ID #: ORTHOPACT (PI: M Briguglio)
• Secondary ID: L4144
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: February 2024

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Galeazzi
• Contact: Elena Cittera
• Phone: 00390283502224
• Email: elena.cittera[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthrosis; Spine
• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amelioration of functions evaluated through the Oswestry Disability Index (ODI)		3 months