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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
Three sachet of protein supplement to be mixed in with water used daily.
Three sachet of Carbo Mass supplement to be mixed in with water used daily.
Zahra vahdat shariatpanahi
Tehran, Iran
Rate of vertebral fusion in CT scan
Rate of formation of a solid bony Union in CT scan
Time frame: 6 months after surgery
Rate of wound healing
Rate of wound healing, the sutures of the surgery, inspected by granulation tissue formation.
Time frame: Discharge, 15 days and 1 month after surgery
Rate of of wound infection
Rate of of wound infection, revealed by physical examination
Time frame: 15 days, 1 and 3 month after surgery
score of pre and postoperative pain
pain measured by the visual analogue scale or visual analog scale (VAS) questionnaire
Time frame: baseline, discharge, 15 days 1 and 3 month after surgery
Concentration of serum IGF-1
Concentration of Insulin-like growth factor-1
Time frame: baseline, 1 month after surgery
Concentration of serum albumin
Concentration of serum albumin
Time frame: baseline, 1 month after surgery
Concentration of serum total protein
Concentration of serum total protein
Time frame: baseline, 1 month after surgery
Concentration of serum hsCRP
Concentration of serum high-sensitivity C-reactive protein
Time frame: baseline, 48 hour,15 days and 1 month after the surgery
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