Preoperative Immunonutrition in Patients Undergoing Spine Surgery

NCT05372289 | Unknown DMC

• 2 other identifiers: ORTHOPACT (PI: M Briguglio)L4144
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthrosis; Spine

Outcome Measures

Primary Outcomes (1)

• Amelioration of functions evaluated through the Oswestry Disability Index (ODI)

  3 months

Study Arms (2)

Supplemented patients

EXPERIMENTAL

Dietary Supplement: Immuno-nutrition

Standard of care

NO INTERVENTION

Interventions

Immuno-nutrition 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.

Supplemented patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Matteo Briguglio

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Cittera

CONTACT

00390283502224; elena.cittera@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: March 16, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

IT (1)