An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- SMFA
研究概览
简要总结
The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient is indicated for total ankle arthroplasty
- •Patient is at least 21 years of age
- •Patient is likely to be available for follow-up out to 10 years
- •Patient is willing to participate by complying with pre- and postoperative visit requirements
- •Patient is willing and able to read and sign a study informed consent form
排除标准
- •Patient with excessive bone loss at the ankle joint site
- •Patient with severe osteoporosis
- •Patient with complete talar avascular necrosis
- •Patient with active osteomyelitis
- •Patient with infection at the ankle site or infection at distant sites that could migrate to the ankle
- •Patient with sepsis
- •Patient with vascular deficiency in the involved limb
- •Pateint with neuropathic joints
- •Patient with neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing
- •Patient with poor soft tissue coverage around the ankle
- •Patient with Charcot arthropathy
- •Previsous ankle arthrodesis with excision of the malleoli
- •Excessive loads as cuased by activity or patient weight - per investigator discretion
- •Skeletally immature patients (patient is less than 21 years if age at time of surgery)
- •Patient with dementia
- •Patient with known metal allergies
- •Patients who are unwilling to provide informed consent
- •Patients who are unlikely to be available for follow-up out to 10 years
- •Patients who are not deemed suitable candidates for the subject device
- •Patient is pregnant
结局指标
主要结局
SMFA
时间窗: Through study completion, an average of 1 per year
Short Musculoskeletal Function Assessment (SMFA) Score - 46 items Patient questionnaire divided into two sections: 34 questions on patients function assessment and 12 questions covering how bothered patients are by their symptoms where 1 indicates no problems/no difficulty/ not bothered and 5 indicates unable to do/symptoms all the time/being greatly bothered
SF-36
时间窗: Through study completion, an average of 1 per year
Short Form Health Survey (SF-36) Score - 36-item patient-reproted survey of patient health - It consists on 8 scales: Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each scale is transformed into a 0-100 scale where the lower score indicates the more disability and the higher score the lest disability
VAS Pain score and Patient Satisfaction
时间窗: Through study completion, an average of 1 per year
Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity
Sports Frequency Score
时间窗: Through study completion, an average of 1 per year
Sports Frequency Score - Level of sport activity in leisure time where 0 indicates "no sports activity" and 4 indicates "professional level of sports activity, elite athlete
AOFAS
时间窗: Through study completion, an average of 1 per year
American Orthopedic Foot and Ankle Society Score (AOFAS) - Questionaire on pain (40 points), function (45 points) , and alignment (15 points) - 100 points score where 100 indicates a healthy midfoot
次要结局
未报告次要终点