Lumbar Spine Disease, Spinal Fusion, Vitamin D
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTvitamin D3
vitamin D3 (cholecalciferol) 800 IU QD
DIETARY_SUPPLEMENTcalcium
calcium citrate 600 mg QD
Sponsors
Show Chwan Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fusion rate at postoperative 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to fusion | from postoperative day 1 to postoperative 1 year | 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 |
| spine function at postoperative 3 months | 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. |
| spine function at postoperative 6 months | postoperative 6 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. |
| pain at postoperative 3 months | 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). |
| pain at postoperative 6 months | postoperative 6 months | Degree of pain was evaluated using visual analogue scale (VAS), which ranges from 0 to 10 (0 = least pain, 10 = worst pain). |
Countries
Taiwan
Outcome results
None listed