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临床试验/NCT05691062
NCT05691062Enrolling By Invitation4 期

A Prospective, Randomized Comparison of Titanium vs. PEEK Fusion Devices in 1 Level TLIF

Twin Cities Spine Center2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
Enrolling By Invitation
发起方
入组人数
80
试验地点
2
主要终点
Revision Surgeries

研究概览

简要总结

The objective of this study is to evaluate and follow the clinical and radiographic outcomes of patients undergoing 1 level TLIF randomized to either a titanium or a PEEK spacer to 24 months after surgery.

详细描述

Transforaminal lumbar interbody fusion (TLIF) remains a common surgical technique for the management of lumbar spondylosis requiring decompression and fusion. The choice of interbody spacer remains dependent on surgeon preference with a variety of options available for use. Two of the most commonly used interbody spacers are made of polyetheretherketone (PEEK) and titanium.1 While both spacers have produced reliable rates of fusion with good clinical outcomes, debate remains as to which interbody spacer is superior. Proponents of PEEK argue that it is radiolucent and has an elastic modulus similar to bone thus decreasing rates of subsidence. However, PEEK is a hydrophobic material that does not integrate with bone. Titanium on the other hand demonstrates osseointegration and may lead to increased rates of fusion.While there are retrospective studies available comparing the two materials, the studies are small and there is a paucity of prospective data comparing the radiographic and clinical outcomes of these spacers. Given the frequency with which these spacers are used, it is important to determine which spacer produces better clinical and radiographic outcomes for patients.

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

Subjects will be blinded to fusion device.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing 1 level TLIF for the treatment of lumbar stenosis and spondylolisthesis who have failed at least 6 weeks of non-operative treatment.
  • Patients between 18-70 years of age at the time of surgery.

排除标准

  • Patients under 18 or over 70 years of age at the time of surgery.
  • Patients undergoing more than 1 level of surgery.
  • Patients who have had prior lumbar fusion.
  • Patients requiring surgery for the management of infection, tumor, or trauma.
  • Patients who are pregnant.

结局指标

主要结局

Revision Surgeries

时间窗: Up to 24 months Post-op

Monitor and Record Complications and Revision Surgeries

Fusion Status of 1 level Lumbar TLIF

时间窗: 12 months Post-Op

Assess fusion status of 1 level Lumbar TLIF by reviewing patient CT Scan completed for study purposes.

次要结局

  • Patient Reported Outcome Measures(Preoperative time frame up to 24 months Post-op)

研究者

发起方
Twin Cities Spine Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bayard Carlson

Staff Surgeon

Twin Cities Spine Center

研究点 (2)

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