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Completed

NCT Number: NCT04091841

Trial of Protein Supplement on Vertebral Fusion in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zahra vahdat shariatpanahi

Tehran, +98, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

protein supplement

Drug

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

Other names: Pure-protein

Carbo Mass

Other

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

Primary outcomes

  1. Rate of vertebral fusion in CT scan

    Time frame: 6 months after surgery

    Rate of formation of a solid bony Union in CT scan

Secondary outcomes

  1. Rate of wound healing

    Time frame: Discharge, 15 days and 1 month after surgery

    Rate of wound healing, the sutures of the surgery, inspected by granulation tissue formation.

  2. Rate of of wound infection

    Time frame: 15 days, 1 and 3 month after surgery

    Rate of of wound infection, revealed by physical examination

  3. score of pre and postoperative pain

    Time frame: baseline, discharge, 15 days 1 and 3 month after surgery

    pain measured by the visual analogue scale or visual analog scale (VAS) questionnaire

  4. Concentration of serum IGF-1

    Time frame: baseline, 1 month after surgery

    Concentration of Insulin-like growth factor-1

  5. Concentration of serum albumin

    Time frame: baseline, 1 month after surgery

    Concentration of serum albumin

  6. Concentration of serum total protein

    Time frame: baseline, 1 month after surgery

    Concentration of serum total protein

  7. Concentration of serum hsCRP

    Time frame: baseline, 48 hour,15 days and 1 month after the surgery

    Concentration of serum high-sensitivity C-reactive protein

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2019
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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