Post-market Clinical Study of the Fortilink-TC Ti
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in ODI score at 12 months follow-up
研究概览
简要总结
This study is setup to be able to gather information on the safety and performance of the Fortilink-TC Ti cage of Paradigm Spine GmbH, up to one year after the surgery. The device is intended to be used in intervertebral fusion surgery. Around 50 participants will participate in this study in 2 hospitals. The Fortilink-TC Ti cage is meant to be placed in the lower back, to treat degenerative disc disease with up to grade I spondylolisthesis. The study will involve data gathering based on routine care. The study will only entail collection of data (medical history prior to the surgery, data from the surgery and data in the follow up after one year). Fortilink-TC Ti cages are not new, but have been on the market since 2020. The clinical study is performed to actively gather data on the use of this product in the intended group of patients, to monitor its safety and performance. The treatment and follow-up provided in this study does not differ from the standard of care; meaning that participants in the study will receive the same treatment and follow the same follow-up visits and assessments as patients undergoing the same procedure outside of the study.
详细描述
This study is setup to be able to gather information on the safety and performance of the Fortilink-TC Ti cage of Paradigm Spine GmbH, up to one year after the surgery. The device is intended to be used in intervertebral fusion surgery. Around 50 participants will participate in this study in 2 hospitals. The Fortilink-TC Ti cage is meant to be placed in the lower back, to treat degenerative disc disease with up to grade I spondylolisthesis. The study will involve data gathering based on routine care. The study will only entail collection of data (medical history prior to the surgery, data from the surgery and data in the follow up after one year). Fortilink-TC Ti cages are not new, but have been on the market since 2020. The clinical study is performed to actively gather data on the use of this product in the intended group of patients, to monitor its safety and performance. The treatment and follow-up provided in this study does not differ from the standard of care; meaning that participants in the study will receive the same treatment and follow the same follow-up visits and assessments as patients undergoing the same procedure outside of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give voluntary informed consent
- •Skeletally mature patients
- •At least 6 months of non-operative treatment
- •Degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels between L2 and S1, with DDD being defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or up to grade 1 spondylolisthesis of the lumbar spine at one or two contiguous levels between L2 and S1
排除标准
- •Active systematic infection or an active infection at the operative site
- •A demonstrated allergy or sensitivity to any of the implanted materials
- •Severe osteoporosis (confirmed by imaging in the patient's medical history or during screening)
- •Primary or metastatic tumours affecting the spine (confirmed by imaging in the patient's medical history or during screening)
- •Conditions that may place excessive stresses on the bones and the implants, including but not limited to morbid obesity or other degenerative diseases, at the discretion of the investigator
- •Patients whose ability to follow postoperative restrictions, precautions and rehabilitation programs is limited
- •Fractures, severe deformities or a severe instability in the area of surgery (confirmed by imaging in the patient's medical history or during screening)
- •A medical or surgical situation that would preclude the benefit of surgery
- •Patient's denial for operative treatment, post-operative rehabilitation program, follow up appointments and/or participation in the trial
- •Protocol specified surgical technique cannot be followed for the subject
- •Any other reason (in the judgment of the investigator).
研究组 & 干预措施
Fortilink-TC - treated patients
干预措施: Transforaminal lumbar interbody fusion surgery (Procedure)
结局指标
主要结局
Change in ODI score at 12 months follow-up
时间窗: Improvement in ODI score at 12 months over baseline
Change between baseline and 12 months follow-up
次要结局
- Incidence of imaging-confirmed complications(During follow-up through 12 months post-surgery)
- Radiographic fusion status(During follow-up through 12 months post-surgery)
- Change in VAS back and leg pain scores(Baseline to 12 months post-surgery)
- Incidence of complications and adverse events(Up to 12 months post-surgery)