Calcium Phosphate Versus PMMA Cement in Unstable Thoracolumbar Burst Fractures Treated With Dorsal Instrumentation in Patients > 50 Years of Age Randomized Controlled Non-inferiority Trial Design
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 85
- 主要终点
- The change in correction rates when using CaP
研究概览
简要总结
Patients at the age of 50 or older presenting with thoracolumbar fractures including segments TH 6-L5 and A3/A4 fractures according to the AO Spine fracture classification after the acute trauma and planned surgery within 3 weeks following trauma will be asked to participate in a randomized trial in which they will receive either Calciumphosphate (CaP) or Polymethylmethacrylate (PMMA) as part of a standardized treatment approach. Regardless of the group patients are randomized to, all participating patients undergo the same surgical procedure except for the preparation and administration of bone cement. The study participation period for each patient is 1 year from the date of the surgery and includes 4 defined time points that include follow-up clinical visits for imaging and progress checks at 6 weeks, 3 months, 6 months and 12 months after surgery. At each follow-up visit, a combination of questionnaires and radiological imaging will be performed to assess general health status, disability level and pain control, as well as objective results of the surgery. The main outcome measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients and study nurse will be blinded to treatment allocation; however, surgeons cannot be blinded due to different techniques of bone cement application. A centralized and automated internet-based randomization system will ensure concealed randomization of study participants. Participants will be the unit of randomization. Randomization will be carried out with randomizer.at and will occur prior to the surgical procedure.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent of the participant after being informed
- •Acute trauma (surgery within three weeks following trauma)
- •Thoracolumbar fractures including segments TH 6-L5
- •A3/A4 fractures according to the AO Spine fracture classification
- •Patient age ≥ 50 years
- •Minimum follow up 1 year
排除标准
- •Presence of neurological deficits at the time of surgery
- •Pathological fractures (bone metastases)
- •Traumatic brain injury
- •Ankylosing spondylitis as a comorbidity
- •Pregnancy
研究组 & 干预措施
KYPHON® ActivOs™10 Bone Cement with hydroxyapatite
As a reference device KYPHON® ActivOs™10 Bone Cement with hydroxyapatite (Medtronic) for treatment of vertebral compression fractures will be used. It is a polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite (HA) for use in the treatment of patients with vertebral compression fractures (VCFs) who are undergoing minimally invasive surgery with KYPHON® Balloon Kyphoplasty. This bone substitute has already been approved and is in use in the patients at the age of 50 or older.
干预措施: KYPHON ActivOs® Bone Cement with Hydroxyapatite (Device)
KyphOs FS™
The test device KyphOs FS™ will be used in patients at the age of 50 and older in order to prove its superiority over the currently used PMMA bone cement.
干预措施: Kyphos FS™ Bone Substitute (Device)
结局指标
主要结局
The change in correction rates when using CaP
时间窗: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
The main outcome measure 1 will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury.
The change in correction rates when using PMMA
时间窗: Preoperatively (determination of fracture classification), postoperatively (immediately following surgery), 1 year postoperatively
The main outcome 2 measure will be the loss of correction rate that will be measured through the bi-segmental COBB angle presented in the CT-scan. The Cobb angle will be measured between the superior end plate of the vertebral body cephalad to the injury and the inferior end plate of the vertebral body caudal to the injury. Measurements will be taken from CT scans.
次要结局
- Change in quality of life in patients with PMMA measured by the 36-item Short Form Survey(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))
- Changes in complication rates when using PMMA(6 weeks, 3 months, 6 months and 12 months postoperatively)
- Change in the disability on the ODI rating scale in patients with PMMA(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))
- Change in quality of life in patients with CaP measured by the 36-item Short Form Survey(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))
- Changes in complication rates when using CaP(6 weeks, 3 months, 6 months and 12 months postoperatively)
- Change in pain on the spine VAS in patients with PMMA(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))
- The change in vertebral body height when using CaP(Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively)
- The change in vertebral body height when using PMMA(Preoperatively, postoperatively (immediately following the surgery), 1 year postoperatively)
- Change in the disability on the ODI rating scale in patients with CaP(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))
- Change in pain on the spine VAS in patients with CaP(Five times - after the surgery, at each study visit (6 weeks, 3 months, 6 months and 12 months postoperatively))