Survival, Clinical and Radiological Outcomes of Total Ankle Arthroplasty With Lateral Transfibular Approach With a Minimum 10 Years Follow up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- 10 years surviviorship of the implants
研究概览
简要总结
Ankle osteoarthritis is a disabling condition that can significantly impair patients' quality of life. Ankle arthrodesis has historically represented the gold standard for treating this condition [2], but technological advancements achieved with fourth-generation prostheses have considerably improved implant survival and clinical outcomes, making them a viable alternative. Prosthetic implants are mainly categorized into anterior and lateral access approaches; for the latter, short- and medium-term literature data are encouraging, but long-term studies (over 10 years) are lacking. The present study aims to determine whether the results recorded so far remain stable in the long term.
详细描述
Ankle osteoarthritis is a disabling condition that can significantly impair the quality of life of affected patients. Ankle arthrodesis has historically represented the gold standard for treating this condition, but technological advancements achieved with fourth-generation prostheses have considerably improved implant survival and clinical outcomes, making them a viable alternative. Prosthetic implants are mainly categorized into anterior and lateral access approaches; for the latter, short- and medium-term data in the literature are encouraging, but long-term studies (over 10 years) are lacking. The present study aims to determine whether the results recorded so far remain stable in the long term.
The objective of the present study is to evaluate the long-term survival, clinical, and radiological outcomes (minimum 10-year follow-up) of total ankle replacements.
The protocol involves the collection of clinical and radiological data analyzed over the years during outpatient evaluations. Specifically, the evaluations are structured as follows:
-
Evaluation of implant survival at a minimum 10-year follow-up and monitoring of any complications and reoperations using the COFAS Reoperation Coding System (CROCS).
-
Evaluation of clinical outcomes using:
-
AOFAS Questionnaire (Italian version): a specific clinical score for foot and ankle pathologies; despite its limitations, it is used in the majority of similar studies.
-
Visual Analog Scale (VAS) for pain assessment to quantify the intensity of pain perceived by the patient.
-
Ankle joint Range of Motion (ROM).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who underwent total ankle replacement at the IRCCS Galeazzi-Sant'Ambrogio Hospital (formerly Galeazzi Orthopedic Institute) between April 2013 and April 2016 via a transfibular lateral approach with a Zimmer TM prosthesis implant and a minimum follow-up of 10 years
排除标准
- •Revision joint replacements
- •Previous tibiotalar arthrodesis
- •Inability to retrieve follow-up data.
结局指标
主要结局
10 years surviviorship of the implants
时间窗: 10 years
The objective of this study is to evaluate the long-term survival, clinical, and radiological outcomes (minimum 10-year follow-up) of total ankle prostheses implanted via a transfibular approach.
次要结局
未报告次要终点