Efficacy of Sub-laminar and/or Interspinous Tethers to Prevent Proximal Junctional Kyphosis After Surgical Correction of Adult Spinal Deformity - Randomized Multicentric Single Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 6
- 主要终点
- Sub-laminar and/or interspinous tethers efficacy to prevent PJK
研究概览
简要总结
PJK (proximal junctional kyphosis) at the upper end of spinal fusions after surgical correction of adult spinal deformity is not uncommon. Two-thirds of cases are observed within the first 3 months after surgery and 80% within the first 18 months. PJK is consequently a common problem after surgery for adult spinal deformity, representing one of the most frequent complications following this kind of procedure. Although the first-line treatment of this event is conservative, surgery may be necessary in around 30-40% of cases. Revision surgery generally consists of extending the posterior spinal instrumentation.
Prophylactic vertebroplasty has been proposed to reduce the risk of PJK and PJF, with promising results but with the limitation of reinforcing only the bony structures, with no action on the soft tissues. In this context, some authors have reported that the use of tethers, creating a transitional zone at the upper end of the construct between the fused and the non-instrumented spine, could reduce the occurrence of this complication (PJK). One of the hypotheses is that the use of a topping-off system results in a transitional zone reducing stresses at the junctional spine and may reduce the occurrence of both PJK and the need for reoperation.
Compared with other topping-off systems, such as hooks, the surface of contact provided by the bands on the posterior arches is much greater and the primary stability much better. In addition, the risk of malposition is extremely low.
The aim of this study is therefore to compare the occurrence of PJK and PJF in patients for whom tethers were implanted at the upper end of the instrumentation versus patients for whom no tether system was used.
In a retrospective study conducted in the neurosurgery department of the HCL on 38 patients undergoing multilevel spine instrumentation with junctional tethers, PJK occurred in 8 of them (21%) after 24 months of follow-up.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 三盲 (受试者、医护人员、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Patient men and women older than 18
- Patient indicated spinal posterior fusion and instrumentation with the upper end (UIV with screws) between T9 and L2 and the lower end between L5 and iliac
- Constructs ≥4 levels (i.e., ≥4 discs included)
- Patient able to signed a consent form
- Patient able to fill a self-administered questionnaire
- Patient affiliated to health care insurance (social security in France
排除标准
- Allergy to metal
- Cimentoplasty at the junctional zone (UIV, UIV+1 and/or UIV+2)
- Bone metabolism disorders that potentially compromise the mechanical support expected from this type of implant.
- Morbid obesity (BMI > 40)
- Patients with infection (in particularly osteomyelitis)
- Cancer of lesss than 5 years or currently treated
- Acute trauma
- Immunodepression
- Parkinson
- Chronic inflammatory disease
- Severe psychological disorders
- Pregnancy or women breastfeeding
- Inadequate tissue coverage of implant site,
- Interference with other critical anatomical structures.
- Patient not being able to understand the objectives of the study or refusing to comply with postoperative instructions
- Patient participating in an ongoing study that may interfere with this study
- Patient under legal protection
研究组 & 干预措施
Reference strategy
Standard surgery
干预措施: Reference (Procedure)
Patient instrumented with a tether
Sub-laminar and/or interspinous tethers
干预措施: Tether strategy (Device)
结局指标
主要结局
Sub-laminar and/or interspinous tethers efficacy to prevent PJK
时间窗: From enrollment to 24 months post-surgery
Percentage of patients with PJK during the first post-operative 24 months with PJK defined as : * a proximal junctional sagittal Cobb angle (PJA) between the lower endplate of uppermost instrumented vertebra (UIV) with screws and the upper endplate of 2 supra-adjacent vertebra ≥15 * a 15° delta between 24months post operative PJA and preoperative PJA These 2 parameters will be assessed by an independent committee using radiographic images preop and 24 months postop
次要结局
- Sub-laminar and/or interspinous tethers efficacy to prevent PJF(From enrollment to 24 months post-surgery)
- Sub-laminar and/or interspinous tethers efficacy to prevent surgery revision(From enrollment to 24 months post-surgery)
- Sub-laminar and/or interspinous tethers efficacy to prevent the level of disabilty(From enrollment to 24 months post-surgery)
- Sub-laminar and/or interspinous tethers efficacy to prevent pain(From enrollment to 24 months post-surgery)
- Sub-laminar and/or interspinous tethers efficacy to enhance quality of life(From enrollment to 24 months post-surgery)
- Sub-laminar and/or interspinous tethers efficacy to prevent post-operative complications(From enrollment to 24 months post-surgery)
- Assess the efficiency of implanting tethers at the upper part of the construct in patient with an indication for spinal posterior fusion performing cost-utility and cost-effectiveness analyses(From enrollment to 24 months post-surgery)
研究者
研究点 (6)
标识符
- NCT 编号
- NCT07618897
- 其他研究编号
- 69HCL24_0720, 2026-A00732-49
日期
- 首次提交
- (4个月前)
- 首次发布
- (4个月前)
- 主要完成日期
- (3年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否