A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Ankle Osteoarthritis Scale (AOS)
研究概览
简要总结
The goal of this study is to demonstrate the safety and performance of the Incompass™ Total Ankle System after surgery over the standard follow-up period. The study will measure improvements in patient-reported information related to quality of life and pain following surgery. In order to do this, medical imaging (i.e. X-Rays, CT scans) which have been taken as part of routine care, will be reviewed. Any additional X-Rays conducted during the period of the research will also be reviewed.
The Incompass™ Total Ankle System has been cleared by the Food and Drug Administration (FDA). The products are already in use routinely in ankle replacement surgeries. No part of this study is experimental.
详细描述
It is anticipated that a total of 200 subjects will be enrolled at up to ten sites over a three year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with a total ankle replacement including imaging (x-rays and or CT scans).
The primary endpoint of this study is the 24-month total Ankle Osteoarthritis Scale (AOS) score improvement after index surgery (or Initial Assessment). Secondary endpoints include safety (adverse events, reoperation, and survivorship) as well as performance measures (radiographic assessments, PROMIS Global Health questionnaire, Foot and Ankle Ability Measure [FAAM] and Total Ankle Replacement [TAR] Satisfaction questionnaires).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must be willing and able to sign a written approved informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC)
- •Participants must be males or non-pregnant females aged 21 years or older at the time of surgery;
- •Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits.
- •The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires.
- •Considered a candidate for total ankle replacement with the Incompass Total Ankle System in accordance with its legally approved Indication for Use (IFU).
排除标准
- •Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement;
- •Participant is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results;
- •Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.
- •Participants who have participated previously in this clinical trial and who have been withdrawn.
- •Participant who is, or will be, inaccessible for follow-up
- •Participant is pregnant or intends to become pregnant during the course of the study.
- •Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation.
- •Participants requiring revision total ankle replacement of the ankle being considered for the study;
- •Participants with a failed previous ankle surgery (e.g., takedown fusion)
- •Participants with any infection at the ankle site or infections at distant sites that could migrate to the ankle, including sepsis and osteomyelitis;
- •Participants with compromised vascularity that would inhibit blood supply to the operative site;
- •Neuropathic arthropathy of the joint;
- •Insufficient bone stock or bone quality that cannot provide adequate support of the device;
- •Participants who have documented or suspected sensitivity to the implant materials.
- •Participants with inadequate neuromuscular status or those having poor skin coverage around the joint, which would make the procedure unjustifiable
- •Participant who routinely place excessive loads on their ankle as caused by activity and/or patient weight, per investigator discretion; or
- •Any mental or neuromuscular disorder that would create an unacceptable risk of failure or complications in postoperative care.
研究组 & 干预措施
Incompass™ Total Ankle System
Primary Total Ankle Replacement using the Incompass™ Total Ankle System
干预措施: Total Ankle Replacement (Device)
结局指标
主要结局
Ankle Osteoarthritis Scale (AOS)
时间窗: Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
The AOS questionnaire consists of two 9-item subscales: one for pain and one for disability. Each subscale uses a visual analogue scale where patients mark a point on a 100mm horizontal line anchored by "No pain" and "Worst pain imaginable" for pain, or "No difficulty" and "So difficult unable" for disability
次要结局
- Foot and Ankle Ability Measure (FAAM)(Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year)
- Safety - Survivorship(Baseline to 10 years.)
- TAR Satisfaction(6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year)
- Radiographic Findings(Baseline, 6 months, 1 year, 2 year, 5 year, 7 year, 10 year.)
- Safety - Adverse Event(Baseline to 10 years postoperative)
- PROMIS Scale v1.2- Global Physical Health Score(Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year)
- PROMIS Scale v1.2- Global Mental Health Score(Baseline, 6 Month, 1 Year, 2 year, 5 Year, 7 year, 10 Year)