Prospective Post Market Clinical Follow-Up (PMCF) Study of the Zimmer® Trabecular Metal™ Total Ankle
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 22
- 主要终点
- Survivorship
研究概览
简要总结
The primary objective of this study is to obtain implant survivorship and clinical outcome data for commercially available Zimmer Trabecular Metal Total Ankle implants used in primary or revision total ankle arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.
详细描述
The study design is a prospective, multicenter, study of the commercially available Zimmer Trabecular Metal Ankle semiconstrained implants. The study will require each site to obtain Institutional Review Board approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their primary or revision total ankle arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 month, 1 year, 2, 3, 5, 7, and 10 years. Follow-up surveys will occur at 4, 6, 8, and 9 years.
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
- 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
- •The patient is > 18 years of age
- •The patient is skeletally mature
- •The patient qualifies for primary or revision total ankle replacement based on physical exam and medical history including the following: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis.
- •The patient is willing and able to provide written informed consent
- •Patient is willing and able to cooperate in the required post-operative therapy
- •The patient is willing and able to complete scheduled follow-up evaluations questionnaires as described in the Informed Consent
- •The patient has participated in the Informed Consent process and has signed the Institutional Review Board/European Commission approved Informed Consent
排除标准
- •The patient is: a prisoner, mentally incompetent or unable to understand what participation in the study entails, a known alcohol or drug abuser, anticipated to be non-compliant.
- •The patient has one of the following compromising the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological or vascular disease, loss of musculature or neuromuscular compromise, severe instability, maltracking or misalignment of the tibia and talus uncorrectable by surgery.
- •The patient has a local/systemic infection that may affect the prosthetic joint
- •The patient has a previous history of infection in the affected joint
- •The patient is known to be pregnant
- •The patient has insufficient bone stock or bone quality to fix the components (i.e. osteoporosis, Charcot's disease)
- •The patient has a known sensitivity or allergic reaction to one or more of the implanted materials
- •The patient is unwilling or unable to give consent or to comply with the follow-up program
研究组 & 干预措施
Zimmer TM Total Ankle System
Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System
干预措施: Zimmer Trabecular Metal Total Ankle System (Device)
结局指标
主要结局
Survivorship
时间窗: 10 years
Survival of the implants after 10 years which is based on removal of the prosthesis and will be determined using the Kaplan Meier Method.
次要结局
- American Orthopaedic Foot and Ankle Society Score(First 2 years)