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

Not Applicable

Completed

• Conditions: Spine Surgery
• Interventions: Drug: protein supplement; Other: Carbo Mass

• Registration Number: NCT04091841
• Lead Sponsor: Shahid Beheshti University

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-09-14
• Study First Posted: 2019-09-17
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

• Allergy or intolerance to protein or maltodextrine supplement
• Unwillingness to continue cooperation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
protein supplement	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.
Carbo Mass	Carbo Mass	Control patients will be received protein diet (1.2 g/kg/day) and Carbo Mass for 1 month after surgery.

Primary Outcome Measures

Name	Time	Method
Rate of vertebral fusion in CT scan	6 months after surgery	Rate of formation of a solid bony Union in CT scan

Secondary Outcome Measures

Name	Time	Method
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
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 IGF-1	baseline, 1 month after surgery	Concentration of Insulin-like growth factor-1
Concentration of serum albumin	baseline, 1 month after surgery	Concentration of serum albumin
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

Trial Locations

Locations (1)

Zahra vahdat shariatpanahi; 🇮🇷 Tehran, Iran, Islamic Republic of