NCT04091841

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Shahid Beheshti University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spine Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2019-09-17
• Last updated: 2020-11-30

Locations

1 site across 1 country: Iran