A Multi-Center Prospective Study of Vertebral Technologies, Inc. (VTI) InterFuse® S and InterFuse® T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Lordosis
研究概览
简要总结
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. Comparisons will be made with published historical data..
详细描述
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. While there is no concurrent control population, there is ample historical control data to be used for comparison.
The study will include up to two hundred (200) patients, up to 10 centers, and provide a prospective evaluation of the InterFuse "T" and/or InterFuse "S" Interbody Fusion System. Primary endpoints will be assessed at twelve months post-surgery. All patients enrolled in the study will be followed for at least 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •The patients has a planned fusion construct of at least five levels and will have the InterFuse (S) or (T) planned for L5-S1 and/or L4-L
- •The patient has documented conservative (non-operative) treatment for at least 6 months.
- •The patient has a VAS score of ≥ 60 mm for Back and/or Leg.
- •The patient has an ODI ≥ 40%.
- •The general condition of the patient is appropriate for surgery, as evaluated by the Investigator.
- •The patient is willing and able to comply with study requirements.
- •The patient has agreed to participate in the study
排除标准
- •The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s). Previous non-fusion surgery at the proposed treatment level(s) is acceptable.
- •The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age.
- •The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).
- •The patient has known neoplastic disease other than skin cancer.
- •The patient has a Body Mass Index (BMI) of greater than 40; BMI = wt (kg)/ht2 (m2).
- •The patient has an active infection.
- •The patient is pregnant or is planning on becoming pregnant in the next two years.
- •The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.
- •The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum.
- •The patient is currently enrolled in an investigational spine study.
- •The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.
- •The patient has symptomatic fibrous arachroiditis.
结局指标
主要结局
Lordosis
时间窗: 24 months
retention of restored degree of lordosis
Fusion
时间窗: 24 months
Speed of fusion
disc height retention
时间窗: 24 months
loss of restored disc height over time
Complications
时间窗: 24 months
Migration, subsidence, hardware lossening and others
次要结局
- Pain and function Scores(24 months)
- Scoliosis Research Society (SRS) Scores(24 months)
- Complications II(24 months)