Antibiotic-coated and Uncoated Titanium Nails in Tibia Fractures and Revision Cases Retrospective Cohort Study/ Long-term Clinical Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 397
- 试验地点
- 2
- 主要终点
- infection
研究概览
简要总结
For this retrospective cohort study, medical records of patients treated between 2005 to 2019 with the UTN PROtect and/or ETN PROtect for tibia fractures or tibia revision cases will be examined. In comparison to this cohort, patients who received an uncoated tibia nail are examined as well. Demographics, pre-surgical health status, details on fracture type or on revision, treatment decision and surgery details, postoperative reoperation and revision, surgical site infections, time to union, and adverse events will be registered. In a subgroup, additional information including clinical outcomes and patient satisfaction will be assessed by clinical exam. Patients who still carry a nail and feel discomfort at the surgical site or present with a medical condition which demands an imaging will receive an x-ray of the tibia. The xray is not part of the standard study protocol.
详细描述
Primary Objective:
The primary objective is to assess the proportion of patients who experienced a surgical site infection. Surgical site infection is defined as either deep or superficial. The presence of tibia infection will be defined by the criteria of CDC.
Secondary Objective(s):
- Proportion of patients with reoperation (secondary procedures)
- Bone union (until radiographically healed)
- Proportion of patients with complications / Adverse Events related to implant or surgery
- Only Subgroup: WOMAC-Score, AOFAS, SF36, EQ5D.
Hypothesis and Statistical considerations and estimated enrollment:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary tibial shaft fracture (fracture type 42 according to the AO/OTA Fracture and Dislocation Classification) treated operatively with an intramedullary nail as Standard of care.
- •Signed informed consent, if required by IRB/EC
排除标准
- •- Prisoner at date of inclusion
结局指标
主要结局
infection
时间窗: 15 years maximum
Occurrence and time-point of surgical site infection
次要结局
- fracture consolidation(15 years maximum)
- Duration of postoperative immobilization and non-weight bearing(15 years maximum)
- complications/Adverse Events related to implant or surgery(15 years maximum)