Fragility Fractures of the Pelvis: Observational Outcome Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 420
- 试验地点
- 20
- 主要终点
- Comorbidities
研究概览
简要总结
Prospective data will be collected in approximately 420 patients, above the age of 65, suffering from an FFP type fracture equal to or higher than type II, according to Rommens and Hofmann.
Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s, radiological outcomes, and anticipated or procedure-related adverse events (i.e. complications).
详细描述
More in detail this registry has the following objectives:
- To identify the difference in patient related outcome comparing the surgical and conservative treatment in patients suffering from an FFP with different levels of pelvic instability at different time points
- To compare the rate of complications, morbidity and mortality between the different treatment modalities over the whole study period
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older at time of injury
- •Diagnosis, via CT scan as per standard of care, of FFP grade II or higher according to the Rommens and Hofmann classification (including fractures of the anterior pelvic ring involving the anterior lip of the acetabulum not regarded as the acetabular fractures)
- •Informed consent obtained, ie:
- •Ability to understand the content of the patient information/ICF
- •Willingness and ability to participate in the registry according to the standard of care in each clinic
- •Signed and dated Ethics Committee (EC)/ Institutional Review Board (IRB) approved written informed consent OR
- •Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent
排除标准
- •Pelvic fractures that do not meet the criteria of a fragility fracture (ie, high-energy trauma)
- •FFP type I fractures
- •Concomitant fractures of the acetabulum (except anterior lip of the acetabulum, see above)
- •Pathological fractures (ie, patients with malignant or metastatic diseases of the pelvis, infections)
- •Concomitant osteoporotic fractures outside of pelvis
- •Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present registry
研究组 & 干预措施
Pelvis fracture type II to IV
All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. The registry does not dictate any specific treatment.
结局指标
主要结局
Comorbidities
时间窗: Pre-treatment
Concomitant diseases will be assessed using the Charlson Comorbidity Index (CCI). This score assesses the comorbidity level by considering both the number and severity of pre-defined comorbid conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates. It is a 17-items questionnaire with score range from 0 to 37 points. It estimates the 10-year (or shorter) patient survival.
Demographics
时间窗: Pre-treatment
Year of birth, Gender, Ethnicity, Height (cm) and Weight (kg) will be combined to report BMI in kg/m\^2
Patient Reported Outcomes - EuroQoL (EQ-5D-3L)
时间窗: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
The EQ-5D-3L has five items (mobility, self-care, usual activities, pain/discomfort anxiety/depression) with a three-point categorical response scale level (1 = no problems, 2 = some / moderate problems, 3 = extreme problems) where the patient's current health status is assessed. A unique EQ-5D-3L health state is defined by combining one level from each of the five dimensions. The EQ-5D index score ranges from 0 (death) to 1 (best imaginable quality of life), and negative values express "worse than death" state.
Cognitive status
时间窗: Pre-treatment
The MiniCog is a 3-minute instrument assessing cognitive impairment. It consists of two components, a 3-item recall test for memory and a simply scored clock drawing test. A total score ranges from 0 to 5. A score of zero, one or two out of five points in total, indicates a concern in cognitive functioning.
Patient-reported outcomes: PROMIS Pain Interference
时间窗: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference (8 questions) assesses the impact of pain on common activities of daily life including social, cognitive, emotional, physical, and recreational aspects. The higher score represents a higher pain level.
Patient-reported outcomes: PROMIS Physical Function
时间窗: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
PROMIS Physical Function (10 questions) assesses self-reported capability of physical activities including instrumental activities of daily living. A higher score indicates a better self-reported capability.
次要结局
- Modified Barthel index(from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical))
- Parker Mobility Score(from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical))
- Residential status(from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical))
- Mortality(from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical))
- Radiological outcomes(from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical))
- Anticipated treatment or condition-related adverse events (i.e. complications)(from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical))