The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion

Show Chwan Memorial Hospital34 enrolled

Overview

The process of bony fusion is a dynamic bone remodeling process and a variety of risk factors have been identified to contribute to pseudoarthrosis.Vitamin D deficiency has been reported to be associated with more pseudoarthrosis, prolonged time to fusion, and poorer spine function and quality of life after spinal fusion.However, as the review article presented, it lacks high-quality evidence to investigate the role of vitamin D supplements in spinal fusion. Therefore, this randomized controlled trial aimed to evaluate the effectiveness of oral vitamin D supplements on fusion outcomes in patients receiving elective lumbar spinal fusion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vitamin D Spinal Fusion Lumbar Spine Disease

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 20 and 80 years * Indicated of elective spine fusion surgery for spinal stenosis or degenerative spondylolisthesis at the study hospital from January 2016 to December 2017. Exclusion Criteria: * Spinal instability due to trauma, infection, or malignancy * History of previous spine surgery * Hemodialysis * Long-term steroid use * History of medical treatments for osteoporosis * Postoperative follow-up for less than 12 months * Newly-onset compression fracture after study procedure

Outcomes

Primary Outcomes

fusion rate at postoperative 1 year

Fusion status were assessed by radiography and computed tomography of the lumbar spine. Fusion was defined as the presence of bridging callus without radiolucent line, spinal range of motion between two fused vertebrae less than 5 degrees, and no implant loosening or failure on lumbar spine radiography.

Time frame: postoperative 1 year

Secondary Outcomes

time to fusion

Time to fusion were assessed by radiography and computed tomography (CT) of the lumbar spine.Fusion was defined as the presence of bridging callus without radiolucent line, spinal range of motion between two fused vertebrae less than 5 degrees, and no implant loosening or failure on lumbar spine radiography

Time frame: from postoperative day 1 to postoperative 1 year

spine function at postoperative 3 months

Spine function was evaluated using Oswestry Disability Index (ODI), which contains 10 patient-completed questions addressing spinal function. Each question is presented as 6-point Likert scales from 0 to 5 (0 = best outcome, 5 = worst outcome). The overall ODI score ranges from 0% to 100% and a lower score indicates better function.

Time frame: postoperative 3 months

spine function at postoperative 6 months

Time frame: postoperative 6 months

pain at postoperative 3 months

Degree of pain was evaluated using visual analogue scale (VAS), which ranges from 0 to 10 (0 = least pain, 10 = worst pain).