Spine Surgery
Conditions
Keywords
Protein supplement, Protein diet, Vertebral fusion, Enhanced recovery after surgery, Infection, Wound healing, Pain
Brief summary
Receiving protein can affect the bone formation and maintenance by providing a structural matrix of the bone, optimizing the level of IGF-1, increasing intestinal calcium absorption, transferring phosphorous, and improving muscle strength.Therefore, protein may be effective on vertebral fusion by such mechanisms. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.
Detailed description
A randomized, double blind, controlled trial will be conducted in patients undergoing elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 80 eligible posterior spine fusion surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and control patients will be received Carbo Mass along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of vertebral fusion and enhanced recovery after 3 months surgery.
Interventions
DRUGprotein supplement
Three sachet of protein supplement to be mixed in with water used daily.
OTHERCarbo Mass
Three sachet of Carbo Mass supplement to be mixed in with water used daily.
Sponsors
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients 18-65 years * Body mass index 18.5-30 * Candidate for the elective posterior spine fusion * Without history of severe liver disorder * Without history of Kidney disorder * Without history of diabetes * Without history of trauma and fracture of the vertebral * Without history of osteoporosis * Without history of Gastrointestinal malabsorption * Without history of Parathyroid gland disorders * Without taking medications that affect the metabolism of bone, such as calcitonin, * bisphosphonate, corticosteroid * No smoking * serum level of vitamin 25 (OH) D ≤20 ng/l
Exclusion criteria
* Allergy or intolerance to protein or maltodextrine supplement * Unwillingness to continue cooperation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of vertebral fusion in CT scan | 6 months after surgery | Rate of formation of a solid bony Union in CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of wound healing | Discharge, 15 days and 1 month after surgery | Rate of wound healing, the sutures of the surgery, inspected by granulation tissue formation. |
| Rate of of wound infection | 15 days, 1 and 3 month after surgery | Rate of of wound infection, revealed by physical examination |
| Concentration of serum IGF-1 | baseline, 1 month after surgery | Concentration of Insulin-like growth factor-1 |
| score of pre and postoperative pain | baseline, discharge, 15 days 1 and 3 month after surgery | pain measured by the visual analogue scale or visual analog scale (VAS) questionnaire |
| Concentration of serum total protein | baseline, 1 month after surgery | Concentration of serum total protein |
| Concentration of serum hsCRP | baseline, 48 hour,15 days and 1 month after the surgery | Concentration of serum high-sensitivity C-reactive protein |
| Concentration of serum albumin | baseline, 1 month after surgery | Concentration of serum albumin |
Countries
Iran
Outcome results
None listed