Clinical trial NCT04091841: Trial of Protein Supplement on Vertebral Fusion in Posterior Spine Fusion Surgery
Official title: The Effect of Protein Supplement on Vertebral Fusion and Enhanced Recovery After Posterior Spine Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Surgery
Keywords: Protein supplement
Protein diet
Vertebral fusion
Enhanced recovery after surgery
Infection
Wound healing
Pain
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of vertebral fusion in CT scan
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Rate of wound healing
timeFrame: Discharge, 15 days and 1 month after surgery
measure: Rate of of wound infection
timeFrame: 15 days, 1 and 3 month after surgery
measure: score of pre and postoperative pain
timeFrame: baseline, discharge, 15 days 1 and 3 month after surgery
measure: Concentration of serum IGF-1
timeFrame: baseline, 1 month after surgery
measure: Concentration of serum albumin
timeFrame: baseline, 1 month after surgery
measure: Concentration of serum total protein
timeFrame: baseline, 1 month after surgery
measure: Concentration of serum hsCRP
timeFrame: baseline, 48 hour,15 days and 1 month after the surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Zahra vahdat shariatpanahi
Study officials:
affiliation: Faculty of Nutrition and Food Technology, SBMU
name: zahra vahdat shariatpanahi, MD,PhD
role: STUDY_CHAIR
References: