The Use of a Dynamic Sustained Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Fusion
研究概览
简要总结
The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis utilizing longitudinal weight-bearing computed tomographic imaging. Of particular focus will be assessment of compressive element recovery and its relation to fusion development over time and weight-bearing status. Additionally, the study will incorporate longitudinal fusion assessment to evaluate differences between three-dimensional weight-bearing computed tomography (WBCT) scans and two-dimensional radiographs (X-rays) at multiple points of the fusion process. Finally, the study will evaluate the differences in WBCT-based fusion assessment between automated and manual methodologies for fusion area calculation.
详细描述
This study is a collaborative effort between the Orthopedic Foot and Ankle Center, MedShape, Inc, and CurveBeam. This is a prospective investigation to assess the clinical outcomes of patients with a tibiotalocalcaneal arthrodesis with the Sustained Dynamic Compression Intramedullary Nail (DynaNail), including longitudinal assessment with weight-bearing CT. The investigators plan to enroll 45 patients. No placebo control will be used, as there is no other IM nail available capable of providing sustained compression. Additionally, given that many patients receiving this treatment have had prior failed treatments and face poor alternatives such as amputation, using a prior-generation IM nail as a control treatment would be unethical.
Design:
This is a prospective, single-group study. Patients of the Orthopedic Foot and Ankle Center who are scheduled to undergo TTC arthrodesis will be screened for eligibility and informed consent will be obtained from those who meet the inclusion/exclusion criteria. Subjects will be assessed pre-operatively and then at five post-operative intervals: 1 week, 6 weeks, 3 months, 6 months, and 12 months. A WBCT scan will be obtained at each interval.
Selection of Subjects:
Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon or his/her physician assistant based on clinical exam and radiographic findings. Patients will be screened for eligibility by the research coordinator/ key personnel in close coordination with the surgeon and co-investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Meets indications for TTC arthrodesis and receives the DynaNail implant
- •Able to understand the requirements of the study
- •Willing to comply with the study protocol
- •Sign an Informed consent
- •18 years of age or older
排除标准
- •Investigator determines that the subject is unlikely to comply with the requirements of the study
- •Non-English speaker
- •Illiterate
结局指标
主要结局
Fusion
时间窗: Pre-Operative to 1 year post-surgery
Joint Fusion, as measured by radiographs and CT scans. Fusion rates will be assessed based on varying CT fusion areas. Fusion rates based on X-Ray vs CT assessment will also be compared. CT fusion rates based on varying fusion areas will be compared with PROM data to assess which fusion area actually corresponds to increased function and reduced pain.
次要结局
- FFI-R(Pre-Operative up to one year post-surgery)
- FAAM(Pre-Operative up to one year post-surgery)
- AOFAS(Pre-Operative up to one year post-surgery)
- VAS(Pre-Operative up to one year post-surgery)
- VR-12(Pre-Operative up to one year post-surgery)
- AOS(Pre-Operative up to one year post-surgery)