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

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091841
• Other study ID #: 1398/022
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2020
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Drug:
• protein supplement
Three sachet of protein supplement to be mixed in with water used daily.

Other:
• Carbo Mass
Three sachet of Carbo Mass supplement to be mixed in with water used daily.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Zahra vahdat shariatpanahi	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of vertebral fusion in CT scan	Rate of formation of a solid bony Union in CT scan	6 months after surgery
Secondary	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
Secondary	Rate of of wound infection	Rate of of wound infection, revealed by physical examination	15 days, 1 and 3 month after surgery
Secondary	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
Secondary	Concentration of serum IGF-1	Concentration of Insulin-like growth factor-1	baseline, 1 month after surgery
Secondary	Concentration of serum albumin	Concentration of serum albumin	baseline, 1 month after surgery
Secondary	Concentration of serum total protein	Concentration of serum total protein	baseline, 1 month after surgery
Secondary	Concentration of serum hsCRP	Concentration of serum high-sensitivity C-reactive protein	baseline, 48 hour,15 days and 1 month after the surgery