EXO-SPINE: A Prospective, Multi-center, Double-blind, Randomized, Placebo Controlled Pivotal Study of Ultrasound as Adjunctive Therapy for Increasing Posterolateral Fusion Success Following Single Level Posterior Instrumented Lumbar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 328
- 主要终点
- Number of Participants With Posterolateral Fusion Success at the Treated Level
研究概览
简要总结
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
详细描述
The purpose of this study is to determine whether using active low intensity pulsed ultrasound as adjunct therapy following single level posterior instrumented lumbar surgery increases the posterolateral success rate when compared to inactive (placebo) therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has a documented diagnosis of degenerative disc disease with up to Grade I spondylolisthesis at the target level
- •Requires spinal fusion of a single level disc space (L2 to S1) with the use of local bone graft.
- •Requires a posterolateral fusion procedure with or without an interbody fusion procedure using a posterior approach
- •The subject has failed non-operative treatment lasting at least 6 months.
排除标准
- •Requires spinal fusion at more than one lumbar level.
- •Is pregnant, is lactating or plans to become pregnant before discontinuation of study treatment
研究组 & 干预措施
Exogen 4000+
Low intensity pulsed ultrasound (LIPUS) delivered via Exogen 4000+ (single transducer) device for a treatment duration of 20 minutes per fusion site per day.
干预措施: Exogen 4000+ (Device)
Exogen 4000+ sham
Non-active sham device identical to Exogen 4000+ (single transducer); treatment duration of 20 minutes per fusion site per day
干预措施: Exogen 4000+ sham (Device)
Exospine
Low intensity pulsed ultrasound delivered via Exospine device (dual transducers); treatment duration of 20 minutes per day
干预措施: Exospine (Device)
Exospine sham
Non-active sham device identical to Exospine (dual transducers); treatment duration of 20 minutes per day
干预措施: Exospine sham (Device)
结局指标
主要结局
Number of Participants With Posterolateral Fusion Success at the Treated Level
时间窗: 12 months post treatment start
Fusion success at the treated level was defined as at least 2 of 3 independent blinded radiologists agree all 3 of the following criteria were met. 1. Confirmation of bridging bone based on computed tomography (CT) evidence of a continuous bony connection between the transverse processes on both posterolateral sides, assessed using a numeric grading scale. 2. No evidence of motion defined as \<5° angulation based on flexion and extension radiographs. 3. No evidence of translational movement defined as \<3 mm difference based on flexion and extension radiographs.
次要结局
未报告次要终点