Prospective Open Label Post Market Clinical Follow-up to Evaluate the Clinical Usefulness of the Operative Stabilization of Closed and Open Fractures of the Tibia Using Gentamicin - Coated Titanium Nails
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Synthes GmbH
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Quality of Life: SF-12 Physical Component Summary (PCS)
研究概览
简要总结
This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse Events or complications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or more
- •Open or closed tibia fracture according to the surgical technique
排除标准
- •Women who are pregnant or breast-feeding or are planning to become pregnant during the study
- •Patients with consumptive/ malignant primary disease and a life expectancy of < 3 months
- •Patients with a known allergy to aminoglycosides
- •Physical or mental incapacity, which makes it impossible to obtain informed consent
- •History of drug and alcohol abuse
- •Patient unlikely to cooperate
- •Legal incompetence
结局指标
主要结局
Quality of Life: SF-12 Physical Component Summary (PCS)
时间窗: 3, 6, 12 and 18 months post-operatively
The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score \[PCS\] and mental composite score \[MCS\]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively.
Functional Outcome: IOWA Ankle Score
时间窗: Baseline, 3, 6, 12 and 18 months post-operatively
The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function.
Infection Adverse Events
时间窗: 0 - 18 months
Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into: * superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue * deep incisional SSI, affecting deep soft tissue * organ/ space SSI (Osteomyelitis), affecting joint or bursa
Quality of Life: SF-12 Mental Component Summary (MCS)
时间窗: 3, 6, 12 and 18 months post-operatively
The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score \[PCS\] and mental composite score \[MCS\]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person. It was administered at 3, 6, 12 and 18 months post-operatively.
Quality of Life: EQ-5D
时间窗: 3, 6, 12 and 18 months post-operatively
The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.
Functional Outcome: WOMAC
时间窗: 3, 6, 12 and 18 months post-operatively
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee. Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations.
次要结局
- Evidence of Anatomic Bone Union According to Johnson Classification(12 months)
- Evidence of Economic Bone Union According to Johnson Classification(12 months)
- Evidence of Functional Bone Union According to Johnson Classification(12 months)
- Likelihood to Develop Wound Infection Assessed by Surgeon(6 weeks, 3 and 6 months post-operatively)
- Likelihood to Develop a Non-union Assessed by Surgeon(6 weeks, 3 and 6 months post-operatively)
- Time to Full Weight Bearing(0 - 18 months)
- Surgeon's Perceived Satisfaction(6 weeks, 3 and 6 months post-operatively)
- Pain by Visual Analog Scale (VAS)(6 weeks, 3, 6, 12 and 18 months post-operatively)
- Patient's Perceived Satisfaction(6 months)