Lower Extremity Fixation In Neuropathic Patients Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Survival Analysis of Implants at 1 Year
研究概览
简要总结
Prospective, multi-site, multi-year post-market clinical follow-up study on neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites
详细描述
The selected design is a US, multi-center, multi-year, non-randomized, prospective observational study. The study subjects included are neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subject is a male or non-pregnant female age 18 years or older at the time of surgery;
- •Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan (CIP); and
- •Subject has neuropathy and is intended to be treated for deformity with the one or a combination of the below Systems in accordance with the legally cleared/ approved IFU and Surgical Technique Manual.
- •HOFFMANN® LRF SYSTEM
- •SALVATION™ EXTERNAL FIXATION SYSTEM
- •SALVATION™ FUSION BOLTS AND BEAMS
- •SALVATION™ 2 MIDFOOT NAIL
- •SALVATION™ 3DI PLATING SYSTEM
- •T2® ICF SYSTEM
- •VALOR™ ANKLE FUSIO NAIL SYSTEM
排除标准
- •Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated;
- •Unable to consent to participate (written, informed consent);
- •Unable to attend/complete the requested follow-up visits
结局指标
主要结局
Survival Analysis of Implants at 1 Year
时间窗: 1 years
Compare the pooled cumulative 3-year amputation (above or below the knee) rate of neuropathic patients implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM derived from a Kaplan-Meier survival analysis to a performance goal.
次要结局
- EQ-5D-5L- Index(1 year)
- FAAM-ADL(1 years)
- Survival Analysis of Implants at 5 Years(5 years)
- Radiographic Assessment(5 years)
- EQ-5D-5L-VAS(1 Year)