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临床试验/NCT03650010
NCT03650010招募中不适用

Evaluation of Epidemiology and Radiological and Clinical Outcomes in Total Ankle Prosthesis

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 1,066 人开始时间: 2016年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,066
试验地点
1
主要终点
Changes in beta angle

研究概览

简要总结

This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and radiographically.

详细描述

The aim of this study is to evaluate radiographically and clinically using clinical and radiographic outcomes . Few studies exist in the literature and rarely report fix-bearing and mobile-bearing prosthetics [1-4]. Therefore the data related to this study can be considered a reference in the literature.

Patients who performed and will perform ankle prosthesis surgery from January 2011 to March 2026 and who underwent a clinical evaluation (also using questionnaires and scores) and radiographic evaluation.

The clinical data and radiological parameters were collected together with the visits and the procedures prescribed according to the clinical routine of the department.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females
  • age ≥ 18 years at the time of surgery
  • patients who underwent ankle replacement surgery from January 2011 to March 2026

排除标准

  • age < 18 years at the time of surgery

结局指标

主要结局

Changes in beta angle

时间窗: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively

β-angle (normal value 85.0 ± 2.0 degrees). This angle is subtended anteriorly by the longitudinal axis of the tibia and the articular surface of the tibial component on the lateral view

Medial distal tibial angle

时间窗: Pre operatively

It is the angle between the anatomic axis of the tibia and the line connecting the distal point on the medial and lateral articular surface. (normal value 92.4 ± 3.1 degrees).

Anterior distal tibial angle

时间窗: Pre operatively

(ADTA: normal value 83.0 ± 3.6 degrees). The angle is subtended by the anatomic axis of the tibia and the line connecting the distal points on the anterior and posterior tibial articular surface on the anterior side (Figure 1). The tibia axis was defined as the line connecting the centres of two circles designed over the proximal and the distal tibia adjusting their radius to the anterior and posterior tibial cortices.

Changes in alpha angle

时间窗: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively

the α-angle is formed by the angle between the anatomic axis of the tibia and the articular surface of the tibial component on the AP view (normal value 90.0 ± 2.0 degrees)

Changes in Short form 12 (SF 12)

时间窗: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively

The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Changes in American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score

时间窗: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively

The American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments.

次要结局

  • Changes in visual analogue scale(Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively)

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Cittera

FEDERICO USUELLI, MD PRINCIPAL INVESTIGATOR

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

研究点 (1)

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