Outcome And Complications Assessment In The Surgical Treatment Of Distal Fibular Fractures: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Foot and Ankle Disability Index
研究概览
简要总结
From the archives of the IRCCS Rizzoli Orthopedic Institute (SIR2020) all cases of patients undergoing surgical interventions for the reduction and synthesis of fractures of the distal fibula will be retrieved Ankle-fract Version 2.0 8/08/2024 7 isolated or associated with other lesions, treated surgically with placement of anatomical fibula plates and any accessory procedures from 01/01/2019 to 1/1/2024. An overall electronic database will be created and all medical records of these cases will be reviewed.
The pre- and post-operative data of the patients will be analyzed by analyzing the medical records and the post-operative x-rays (x-ray performed as per common clinical practice, present at the institute (IRCCS Istituto Ortopedico Rizzoli) which highlight consolidation of the fracture.
The radiological reports will be read, analyzing when the bony consolidation of the fracture is reported in relation to the time elapsed since the operation.
The questionnaires will be submitted to all patients who have completed the course at 1 year.
All patients who sign the informed consent will be asked to complete the questionnaires either at the time of the follow-up visit by common clinical practice or by telephone, in the event that the patients have exceeded the 1-year follow-up.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from fibula fracture treated surgically through reduction and synthesis with an anatomical fibula plate;
- •patients of both sexes aged between 18-90 years;
- •patients who have given their written informed consent to participate in the study Patients in possession of a post-operative control x-ray examination to evaluate consolidation and alignment (x-ray performed as per common clinical practice).
排除标准
- •patients with severe postural instability;
- •Patients incapable of understanding or wanting;
- •patients with concomitant neurological pathologies that prevent walking and standing
- •bedridden patients.
- •Lack of written informed consent to participate in the study
- •written form to participate in the study
- •Physiotherapy not performed
研究组 & 干预措施
patients
patients suffering from fibula fracture treated surgically through reduction and synthesis with an anatomical fibula plate
干预措施: follow up scores (Other)
结局指标
主要结局
Foot and Ankle Disability Index
时间窗: after 1 year
It is a self-reported questionnaire used to assess functional limitations and disabilities associated with foot and ankle conditions. The FADI consists of two parts: the main part with 26 questions and the additional sports module with 8 questions. Each question is rated on a 5-point scale (0 to 4), with 0 indicating the most difficulty and 4 indicating no difficulty. The scores for each question are added and converted to a percentage, with a higher percentage indicating better function. It is rated on a total of 104 points, with a score of 0 indicating maximum disability and a score of 104 indicating no disability
次要结局
- The American Orthopedic Foot and Ankle Score(after 1 year)
- Visual Analog Score(after 1 year)
- 12-Item Short Form Survey(after 1 year)
- EQ-5D (EuroQoL) Current Health Assessment(after 1 year)
- x-rays analysis(after 1 year)
研究者
Stefano Zaffagnini
Principal investigator
Istituto Ortopedico Rizzoli