Zahra vahdat shariatpanahi
Tehran, +98, Iran
NCT Number: NCT04091841
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Tehran, +98, Iran
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three sachet of protein supplement to be mixed in with water used daily.
Other names: Pure-protein
Three sachet of Carbo Mass supplement to be mixed in with water used daily.
Time frame: 6 months after surgery
Rate of formation of a solid bony Union in CT scan
Time frame: Discharge, 15 days and 1 month after surgery
Rate of wound healing, the sutures of the surgery, inspected by granulation tissue formation.
Time frame: 15 days, 1 and 3 month after surgery
Rate of of wound infection, revealed by physical examination
Time frame: baseline, discharge, 15 days 1 and 3 month after surgery
pain measured by the visual analogue scale or visual analog scale (VAS) questionnaire
Time frame: baseline, 1 month after surgery
Concentration of Insulin-like growth factor-1
Time frame: baseline, 1 month after surgery
Concentration of serum albumin
Time frame: baseline, 1 month after surgery
Concentration of serum total protein
Time frame: baseline, 48 hour,15 days and 1 month after the surgery
Concentration of serum high-sensitivity C-reactive protein
Shahid Beheshti University
Other
The Effect of Protein Supplement on Vertebral Fusion and Enhanced Recovery After Posterior Spine Fusion Surgery
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