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临床试验/NCT01504438
NCT01504438
已完成
不适用

Prospective Randomized Evaluation Of A Two And Three Piece Total Ankle Replacement

Duke University1 个研究点 分布在 1 个国家目标入组 100 人2011年10月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Ankle Osteoarthritis
发起方
Duke University
入组人数
100
试验地点
1
主要终点
Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain
状态
已完成
最后更新
4年前

概览

简要总结

This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Salto-Talaris prothesis.

注册库
clinicaltrials.gov
开始日期
2011年10月
结束日期
2020年3月4日
最后更新
4年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Adult patients (age \> 18 years) who will benefit from a total ankle replacement, as determined by Drs. Nunley, DeOrio, or Easley, with the aid of the physical exam and routine radiography treated at Duke University Medical Center and who have no medical conditions that would represent contraindications to surgery or anesthesia will be asked to participate in this study.

排除标准

  • The only excluded patients will be those who do not choose to participate in this study, have a weight greater than 250lbs, or do not meet the minimum age of 18 years.

结局指标

主要结局

Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain

时间窗: Baseline, 6 months, 1 year, 2 years, 3 years

To assess changes in pain across time following total ankle replacement. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a mark on a 100mm line that represents a continuum between "no pain" and "worst pain." A score of 0 represents less pain intensity while a score of 100 represents high pain intensity

Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire.

时间窗: Baseline, 6 months, 1 year, 2 years, 3 years

The SMFA consists of two sections: 34 questions covering the assessment of the patient's function and 12 questions covering how bothered patients are by their symptoms. Items are scored in six categories: daily activities, emotional status, arm and hand function, mobility category, and bother index. On a scale of 1 to 5, patients rate their ability on each item and higher total scores represent greater degree of dysfunction or bother. SMFA higher total score represent greater degree of dysfunction or bother. The lowest score is 0 representing the best possible function and the highest score is 100 representing an overall higher degree of dysfunction or bother.

Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System

时间窗: Baseline, 6 months, 1 year, 2 years, 3 years

The AOFAS Ankle-Hindfoot Rating System is a standardized evaluation of the clinical status of the ankle-hindfoot. Patients report their pain and physicians assess alignment; the patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points.

Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36).

时间窗: Baseline, 6 months, 1 year, 2 years, 3 years

The SF-36 comprises 36 questions which cover eight domains of health: Limitations in physical activities because of health problems, Limitations in social activities because of physical or emotional problems, Limitations in usual role activities because of physical health problems, Bodily pain, General mental health (psychological distress and well-being), Limitations in usual role activities because of emotional problems, Vitality (energy and fatigue), and General health perceptions. Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high Quality of Life (QOL). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability

To Measure a Change in One's Daily Activity Following a Total Ankle Replacement Using the Foot and Ankle Disability Index (FADI) at Multiple Time Points.

时间窗: Baseline, 6 months, 1 year, 2 years, 3 years

The FADI has 26 items, each of which is scored from 0 (unable to do) to 4 (no difficulty at all). The four pain items of the FADI are scored 0 (none) to 4 (unbearable). The total score ranges 0 to 104 with higher scores indicating a better outcome.

次要结局

  • Three Dimensional Kinematic and Kinetic Assessment During Level Walking Across Time Following Total Ankle Replacement.(Baseline, 6 months, 1 year, 2 years, 3 years)

研究点 (1)

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