A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- radiographic evaluation
研究概览
简要总结
The purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.
详细描述
This is a multi center retrospective study with 200 patients. Sites will screen their patient records for patients who have had a TLIF utilizing the CALIBER® expandable interbody spacer in conjunction with the REVOLVE® or REVERE® posterior stabilization systems and subsequent follow-up visits.
The study aims to collect both pre-operative and post-operative data at the 6, 12 and 24 month time points according to existing standard of care and the surgeon's custom and practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 resulting from degeneration of disc confirmed by history and radiographic studies.
- •At least 18 years of age and maximum 80 years of age
排除标准
- •• Presence of systemic or localized infection at the site of surgery
- •More than 2 levels to be instrumented
- •Previous fusion attempt at the involved level(s)
- •Spondylolisthesis unable to be reduced to Grade 1
- •Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
- •Diagnosis of a condition or on postoperative medication(s), which may interfere with bony/soft tissue healing
- •Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
- •History of substance abuse (drugs or alcohol)
- •Mentally incompetent or prisoner
结局指标
主要结局
radiographic evaluation
时间窗: Pre-Op to 2 years post-operative
Standing anterior-posterior, lateral, flexion and extension images
次要结局
- Clinical outcomes(pre-op to 2 years post-operative)