Related ACE Reports
- Published: Jun 2016
- ACE Report #9127
Vertebral augmentation using SpineJack vs. balloon kyphoplasty for osteoporotic VCF
Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: N/A
Why was this study needed now?
If the conservative management of VCF is unsuccessful, surgical intervention, such as minimally invasive balloon kyphoplasty is often needed. A novel VCF reduction system, SpineJack, has been suggested as an alternative to kyphoplasty that can improve the restoration of the height and alignment of the vertebral column. The present pilot study was conducted to verify the comparative efficacy and safety of the two treatments.
What was the principal research question?
In the treatment of osteoporotic vertebral compression fractures, what are the comparative clinical, radiographic, and safety outcomes between a novel VCF reduction system (SpineJack) and balloon kyphoplasty (KyphX Xpander Inflatable Bone Tamp) when assessed up to 12 months postoperatively?
|Population:||30 patients between the ages of 21 and 75 with painful osteoporotic VCF. Eligibility criteria included VCFs between T7 and L3 that occurred within 3 months prior to study; a 15% to 40% shortened vertebral body; a hyperintense signal on Short T1 inversion recovery (STIR) or T2 sequence magnetic resonance imaging (MRI); unresponsiveness to conservative treatment as indicated by a VAS score of 5 or more after 6 treatment weeks or a VAS score of 7 or more after 2 weeks of treatment; and an Oswestry Disability Index (ODI) score of 30% or more. All patients underwent their procedures under general anesthesia.|
|Intervention:||SpineJack group: patients underwent VCF reduction using the SpineJack 5 mm/KE001 (VEXIM SA, Balma, France). The device was inserted with the patient in the prone position and then expanded using a specialized tool after which cement is injected. (n=15, 14 analyzed; Mean age: 67.9+/-4.5; 11F/4M)|
|Comparison:||Kyphoplasty group: patients underwent balloon kyphoplasty using the 20/3 KyphX Xpander Inflatable Bone Tamp 20 mm and the KyphX HV-R Bone Cement (Medtronic, Sunnyvale, CA, USA). (n=15, 15 analyzed; Mean age: 68.3+/-6.1; 13F/2M)|
|Outcomes:||Clinical outcomes consisted of back pain intensity measured using the visual analogue scale (VAS), use of analgesics, Oswestry Disability Index score, ambulatory status, and quality of life measured using the EQ-VAS score. Radiographic outcomes included restoration of pre-fracture vertebral body height assessed using the change in anterior, mid, and posterior vertebral body length, and changes in the kyphotic, Cobb, and Gardner angles. Safety outcomes of rates of re-operation, rates of re-fracture or subsequent fracture, and proportion of VCFs with cement extravasation were reported. All device-related complications were also documented.|
|Methods:||RCT; prospective, single-center, investigator-initiated, pilot study|
|Time:||Back pain intensity using the VAS and ODI were assessed at 5 days, and 1, 3, 6, and 12 months postoperatively. EQ-VAS was assessed at 1, 3, 6, and 12 months postoperatively. Radiographs were taken at 5 days and 6 and 12 months postoperatively.|
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.