NCT03142958暂停不适用
A Post-Market, Prospective, Non-Randomized, Multi-Center, Open-Label, Clinical Evaluation of the Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 132
- 试验地点
- 11
- 主要终点
- Implant Survivorship
研究概览
简要总结
A post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Cadence Total Ankle System (TAS) when used for primary ankle arthroplasty.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is skeletally mature.
- •The patient qualifies for primary Total Ankle Replacement (TAR) per the surgeon and has a diagnosis of one of the following: Primary Arthritis (e.g. Degenerative Disease), Secondary Arthritis (e.g. Post-Traumatic, Avascular Necrosis, if minimally 2/3 of the talus is preserved), or Systemic Arthritis of the ankle (e.g. Rheumatoid Arthritis, Hemochromatosis).
- •The patient is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent.
- •The patient reads, understands and signs the Institutional Review Board (IRB) approved Informed Consent.
排除标准
- •The patient is Morbidly Obese (defined by Body Mass Index (BMI) > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
- •The patient has one of the following conditions, which could compromise the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological (Charcot's Arthropathy) or vascular disease, loss of musculature or neuromuscular compromise.
- •The patient has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
- •The patient has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
- •The patient is pregnant or plans to become pregnant during the follow up period.
- •The patient has a metabolic disorder or disease that may compromise bone quality (e.g. arthrogryposis etc.), physiological or anatomical anomalies, and/or malignancy/local bone tumors.
- •The patient has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
- •The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
结局指标
主要结局
Implant Survivorship
时间窗: 2 years
Implant survival defined as absence of device removal or revision.
次要结局
- Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline(up to 10 Years)
- Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2)(up to 10 Years)
- Relative change of Pain compared to baseline(up to 10 Years)
- Implant Survivorship(5 and 10 Years)
- Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline(up to 10 Years)
- Relative change of Range Of Motion (ROM) compared to baseline(up to 10 Years)
研究者
研究点 (11)
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