I.R.C.C.S Galeazzi-Sant'Ambrogio Hospital
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.
Arthrosis; Spine
Immuno-nutrition
NA
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 136 participants |
| Masking : | SINGLE |
| 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 : | Immunonnutrition in Spine Surgery to Improve Patient's Outcome: a Randomized Controlled Trial |
| Actual Study Start Date : | 2022-03-16 |
| Estimated Primary Completion Date : | 2024-02 |
| Estimated Study Completion Date : | 2024-02 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 60 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
IRCCS Galeazzi Orthopedic Institute
Milan, Italy,