2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 17
- 主要终点
- Primary Endpoint
研究概览
简要总结
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
详细描述
This investigation is a prospective, multi-center, single-arm study. 98 subjects are to be enrolled in this clinical investigation. Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6, 12, and 24 Months after the index procedure. Safety, efficacy, and effectiveness analyses will be performed for all follow-up points during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or severe pain, loss of mobility and function of the ankle (Buechel-Pappas Scale)
- •Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
- •At least six months of conservative treatment for severe ankle conditions, confirmed by the patient medical history, radiograph studies and medication record
- •Willing and able to give informed consent
排除标准
- •Patients who have not reached skeletal maturity
- •Active or prior deep infection inthe ankle joint or adjacent bones
- •Prior arthrodesis at the involved site
- •History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
- •Obesity (weight greater than 250 lbs)
- •History of current prior drug abuse or alcoholism
- •Any physical condition precluding major surgery
- •Hindfoot malpositioned by more than 35 degrees or forefoot malalignment which would preclude a plantigrade foot
- •Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
- •Avascular necrosis of the talus
- •Inadequate skin coverage above the ankle joint
- •Patients under the age of 35 who are unwilling or unable to accept the physical limitations imposed by ankle arthroplasty, including limitations on certain vigorous physical activities (e.g. basketball, football) and on manual labor
- •Juvenile onset Type I diabetes
- •Adult onset Type II diabetes when accompanied by neuropathic changes or a history of foot infection in either foot
- •Pregnancy
- •Avascular necrosis of the tibia
- •Significant bone tumor of the foot or ankle
- •Severe deformity that would not normally be eligible for ankle surgery
- •Prior surgery and/or injury that has adversely affected the ankle bone stock
- •Severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
- •Insufficient ligament support
- •Motor dysfunction due to neuromuscular impairment
结局指标
主要结局
Primary Endpoint
时间窗: 2 years
The primary objective of this study is to examine the performance of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation. The principal endpoint consists of evaluating the safety and effectiveness of the STAR™ Ankle. Overall patient success is defined as: 1. ≥ 40 point improvement in total Buechel-Pappas Scale score 2. No device failures 3. Radiographic success (no clinically significant radiographic evidence of loosening, tilting or migration \> 4mm) 4. No major complications
次要结局
- Secondary Endpoints(2 years)