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

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

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.

Study Overview

• Status: Completed
• Conditions: Spine Surgery
• Intervention / Treatment: Drug: protein supplement; Other: Carbo Mass

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, +98
    • Zahra vahdat shariatpanahi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Investigators: Study Chair: zahra vahdat shariatpanahi, MD,PhD, Faculty of Nutrition and Food Technology, SBMU

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: September 14, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Infection; Pain; Wound healing; Protein supplement; Enhanced recovery after surgery; Protein diet; Vertebral fusion
• Other Study ID Numbers: 1398/022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No