NCT03247023终止不适用
Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 12
- 主要终点
- Implant survivorship
研究概览
简要总结
This study will evaluate the long term performance and safety data for the Cadence™ Total Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be included if he/she:
- •Is > 18 years of age.
- •Is skeletally mature.
- •Qualifies for primary 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).
- •Is suitable for TAR with CTAS per the study surgeon based on the product indication and having considered deformity, stability, bone quality, soft- tissue envelope, and neurovascular status.
- •Is willing and able to cooperate in the required post-operative therapy.
- •Is willing and able to complete scheduled follow-up visits, evaluations, and questionnaires as described in the Informed Consent or Information Letter and Data Transfer Authorization Form, as applicable.
- •Reads, understands and signs the Ethical Committee approved Informed Consent or Information Letter and Data Transfer Authorization Form, as applicable
排除标准
- •Subjects will be excluded from the study if he/she:
- •Is Morbidly Obese (defined by BMI > 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
- •Is an active nicotine user (smoking, chewing, smokeless tobacco, patch) and unwilling to cease nicotine use within 1 month prior to surgery, and 2 months post-surgery.
- •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.
- •Has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
- •Continues on long-term medication, which may compromise bone stock (e.g. undergoing immunosuppressive therapy, long-term steroids) and is unable to cease medication usage from 3 weeks prior to surgery to 3 weeks post-surgery.
- •Has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
- •Had previous ankle surgery and/or injury that has adversely affected the anklebone stock.
- •Has had or is scheduled to have contralateral TAR surgery.
- •Is pregnant or plans to become pregnant during the follow up period.
- •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.
- •Has severe avascular necrosis of the talus/tibia.
- •Has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
- •Has a known sensitivity or allergic reaction to one or more of the implanted materials.
- •Is a poor candidate for general anesthesia.
- •Is a prisoner, mentally incompetent or unable to understand what participation in this study entails, a known alcohol or drug abuser, or anticipated to be non- compliant.
研究组 & 干预措施
Integra Cadence Total Ankle System
干预措施: Implantation of Integra Cadence Total Ankle System (Device)
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
Implant Survivorship at 2 Years
时间窗: 2 years
Implant survivorship determined by the percentage of participants with survival of the device. Successful device survival was defined as absence of device removal or revision.
次要结局
- Relative change of Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility compared to baseline(up to 10 years)
- Relative change of Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale compared to baseline(up to 10 years)
- Implant survivorship(5 and 10 years)
- Radiographic Success(up to 10 years)
- Relative change of Range of Motion (ROM) compared to baseline(up to 10 years)
- Relative change of Visual Analogue Scale (VAS) Pain compared to baseline(up to 10 years)
- Relative change of Quality of Life Measure Short Form - 36v2 (SF-36v2) compared to baseline(up to 10 years)
- Implant Survivorship at 5 Years and 10 Years(5 years and 10 years)
- Radiographic Assessment: Tibiotalar Range of Motion(Baseline, 1 year, 2 years)
- Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Visual Analogue Scale (VAS) Pain Score: Resting(Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
- Visual Analogue Scale (VAS) Pain Score: Activity(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): Physical Functioning(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Physical Health(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Emotional Problems(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): Energy/Fatigue(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): Emotional Well-being(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): Social Functioning(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): Pain(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): General Health(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): Physical Component Score(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Short Form-36 Version 2 Health Survey (SF-36v2): Mental Component Score(Baseline, 3 months, 6 months, 1 year, 2 years, 5 years)
- Radiographic Success(6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
- Radiographic Assessment: Ankle Dorsiflexion and Plantarflexion Range of Motion(Baseline, 1 year, 2 years)
研究者
研究点 (12)
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