Trial of Protein Supplement on Vertebral Fusion in Posterior Spine Fusion Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Protein Supplement on Vertebral Fusion and Enhanced Recovery After Posterior Spine Fusion Surgery

Conditions
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Spine Surgery

Intervention / Treatment
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* Drug: protein supplement
* Other: Carbo Mass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protein supplement<br>Intervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery. | Drug: protein supplement<br>* Three sachet of protein supplement to be mixed in with water used daily.<br>* Other names: Pure-protein;|
| Placebo Comparator: Carbo Mass<br>Control patients will be received protein diet (1.2 g/kg/day) and Carbo Mass for 1 month after surgery. | Other: Carbo Mass<br>* Three sachet of Carbo Mass supplement to be mixed in with water used daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of vertebral fusion in CT scan | Rate of formation of a solid bony Union in CT scan | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of wound healing | Rate of wound healing, the sutures of the surgery, inspected by granulation tissue formation. | Discharge, 15 days and 1 month after surgery | 
| Rate of of wound infection | Rate of of wound infection, revealed by physical examination | 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 | baseline, discharge, 15 days 1 and 3 month after surgery | 
| Concentration of serum IGF-1 | Concentration of Insulin-like growth factor-1 | baseline, 1 month after surgery | 
| Concentration of serum albumin | Concentration of serum albumin | baseline, 1 month after surgery | 
| Concentration of serum total protein | Concentration of serum total protein | baseline, 1 month after surgery | 
| Concentration of serum hsCRP | Concentration of serum high-sensitivity C-reactive protein | baseline, 48 hour,15 days and 1 month after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein supplement, Protein diet, Vertebral fusion, Enhanced recovery after surgery, Infection, Wound healing, Pain