Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- Time to heal
研究概览
简要总结
TRUFFLE is a register of clinical patient data of failed bone healing and bone non-union after fracture. All patients suffering from a long bone delayed or non-union after fracture and undergoing revision surgery are registered with their clinical data, comorbidities, medication, soft tissue status, radiographic status, Non-Union Scoring System (NUSS) Score and are followed up until final bone healing or end of treatment. The register consists of more than 800 patients cases. The aim is to identify risk factors for healing of non-unions. Data analysis will compare those patients that undergo regular healing to those of insufficient healing.
详细描述
Bone non-union is a severe complication in trauma surgery. It requires complex surgical intervention leading to decisive restrictions for the patient as well as socioeconomic burden for the health care systems. Despite extensive research, up to date, bone healing has not yet been fully understood. Many risk factors impairing bone healing causing delayed healing or even non-union after fracture have been studied in the past. However, these studies mainly focus on secondary and tertiary prevention measures id est when fracture healing is delayed or the non-union is already present. Research concerning the identification of risk factors concerning primary prevention of non-healing after non-union treatment are scarce, usually investigate a certain anatomical location. Also, as the incidence of non-union (5 % to 10 %) is very low, these studies often only include a limited number of cases and brief follow-up periods.
Thus, TRUFFLE was started as a register for non-union cases aiming for large number of patients cases with consisted data and a follow-up period till the end of treatment.
All patients suffering from a long bone delayed or non-union after fracture and undergoing revision surgery are registered with their clinical data, comorbidities, medication, soft tissue status, radiographic status, Non-Union Scoring System (NUSS) Score and are followed up until final bone healing or end of treatment. The register consists of more than 800 patients cases.
All parameters examined are evaluated at the time of non-union index procedure. Data include demographic parameters as age and gender, type of primary injury according to classification of the AO foundation, severity of primary injury (injury severity score (ISS) > 16), Gustilo-Anderson classification at the time of initial trauma, presence of traumatic brain injury, number of previous soft tissue surgeries before non-union index procedure. The state of infection of the designated bone segment stated by proof of microbiological colonization at the time of non-union index procedure is assessed, as well as Weber/Cech classification of non-union. Comorbidities such as diabetes mellitus, cardiovascular disease, rheumatological conditions, cancer and neurological disease (i.e. Parkinson's disease), as well as tobacco smoking and classification according to the American Society of Anesthesiologists (ASA classification) are assessed. Intake of medication and lab parameters are listed. Any subsequent revision surgery related to the designated non-union is included during patients follow-up. The NUSS- Score is evaluated and calculated according to above listed parameters. Also, subjective parameters of patients quality of life are included at non-union index procedure and at subsequent follow-ups.
Bone healing or unsuccessful healing serve as primary outcome parameter as well as time to heal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •age >18 years
- •presence of long bone non-union that required surgical treatment.
- •radiological signs according to the criteria of the Radiographic Union Scale of Tibial fractures (RUST).
- •clinical signs as pain, lack of weight bearing and/or limitation on range of motion.
排除标准
- •age <18 years
- •Patients with non surgical intervention and presence of long bone non-union
- •bone non-union that resulted from elective orthopedic surgery (e.g. osteotomies).
结局指标
主要结局
Time to heal
时间窗: minimum of 1 year up to 5 years after non-union index procedure
Time to heal is defined as the length of time from non-union index procedure to date of last follow-up visit that stated radiographic and clinical success or unsuccessful bone healing (i.e. amputation, total joint replacement).
number of participants with successful bone healing
时间窗: minimum of 1 year up to 5 years after non-union index procedure
End of treatment can either be successful healing or treatment with no success in bone healing (i.e. amputation, total joint replacement). The number of participants reaching successful healing (responders) to those who are not reaching successful healing (non-responders) will be analyzed.
次要结局
- number of medication(minimum of 1 year up to 5 years after non-union index procedure)
- number of participants undergoing type of revision surgery(minimum of 1 year up to 5 years after non-union index procedure)
- Charlson Comorbidity Index(minimum of 1 year up to 5 years after non-union index procedure)
- number of participants suffering from local infection(minimum of 1 year up to 5 years after non-union index procedure)
- Weber Cech classification(minimum of 1 year up to 5 years after non-union index procedure)
- patient reported outcome measures (PROMS)(minimum of 1 year up to 5 years after non-union index procedure)
- NUSS - non union scoring system(minimum of 1 year up to 5 years after non-union index procedure)
- ASA (American Society of Anesthesiologists) classification(minimum of 1 year up to 5 years after non-union index procedure)
研究者
Marie K. Reumann
Principal Investigator, Head of Clinical Trauma Research
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu