INFINITY™ With ADAPTIS™ and EVERLAST™ Technology Total Ankle Replacement Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Functional Status
研究概览
简要总结
An ankle replacement procedure consists of replacing the worn-out joint surfaces of the ankle with metal and plastic components that are shaped to allow continued movement of the ankle. There are several different types of ankle replacement available. Infinity ankle implants are already routinely used in NHS hospitals. The INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system is a development of the Infinity ankle implant, designed to attach to the bone better and to wear out more slowly.
The purpose of the UK ADAPTIS™ Study is to assess the performance and function of the newly introduced INFINITY™ with ADAPTIS™ and EVERLAST™ technology Total Ankle System for total ankle replacement (TAR) or arthroplasty (TAA) and EVERLAST™ Poly Insert that modernises and streamlines Stryker's TAA/TAR portfolio.
UK ADAPTIS is a prospective multi-centre cohort series of INFINITY™ with ADAPTIS™ and EVERLAST™ Technology with Poly Insert for patients requiring primary total ankle replacement (TAR) i.e. Total Ankle Arthroplasty (TAA).
Patients meeting the criteria for the study will be asked to enrol by providing written informed consent.
The patients will be monitored clinically by post-operative follow-up examinations and Patient reported outcome measures (PROMs) (Manchester Oxford Foot & Ankle Questionnaire (MOXFQ), Ankle Osteoarthritis Scale (AOS), EQ5D-5L).
Intended use:
It is intended to give a patient limited mobility by reducing pain, restoring alignment, and replacing flexion and extension movement in the ankle joint.
Indications for use:
- Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
- Patients with a failed previous ankle surgery.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female over the age of 21 years with a diagnosis of end stage ankle arthritis and requiring primary TAA/TAR and is suitable for the use of the ADAPTIS TAA/TAR
- •Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule.
- •Patient can understand and provide written consent.
排除标准
- •Patients with previous ankle arthrodesis or Patients who require revision of previously implanted TAA/TAR.
- •Any patients presenting with clinically relevant conditions prior to implantation, that would contraindicate implantation of a TAA/TAR
研究组 & 干预措施
INFINITY™ with ADAPTIS™ and EVERLAST™
INFINITY™ with ADAPTIS™ and EVERLAST™ technology with Poly Insert for patients requiring primary TAA/TAR.
干预措施: INFINITY™ with ADAPTIS™ and EVERLAST™ (Device)
结局指标
主要结局
Functional Status
时间窗: 2 years
Functional status using MOXFQ (Manchester-Oxford Foot Questionnaire). The MOXFQ is scored on a 0-100 scale, where higher scores indicate more severe problems.
Device Survivorship
时间窗: 2 years
Device survivorship, assessed by tracking revision rates
次要结局
- Pain and Disability(Up to 5 years post-op)