NCT02590783终止不适用
Treatment of Pelvic Ring Fractures in the Elderly: A Randomized Controlled Trial Comparing Surgical vs. Conservative Therapy
University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2017年10月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Mobility at 3 weeks post-diagnosis
研究概览
简要总结
Pelvic ring fractures in the elderly are associated with high morbidity during standard conservative treatment due to immobility. Furthermore the risk of long term dependence even after the fracture has united is high. In analogy to the treatment of hip fractures in a similar patient population, patients might benefit from surgical treatment due to a reduction in pain and early mobilization.
详细描述
Comparison of surgical vs conservative treatment with respect to mobility, pain, morbidity and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •CTI/MRI verified fracture of the sacrum affecting the posterior ring or both posterior and anterior ring
- •age>65 years, ambulatory with/without walking aids before Trauma
- •ambulatory with/without walking aids before trauma
- •postmenopausal status in women
- •informed consent for study participation and surgery
排除标准
- •Refusal of consent by the patient or legal representatives to participate in the study
- •Other fractures or
- •Unstable pelvic fracture (type B or C according to classification of 'Arbeitsgemeinschaft für Osteosynthesefragen' (AO)/OTA) requiring surgical stabilisation after high- or low-energy trauma
- •Suspicion of a pathological fracture in the context of known or unknown malignancy
- •Previous surgery of the pelvis with metal obstructing the planned paths of the ilio-sacral screws
- •Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.
- •Comorbidity that precludes undergoing general or spinal anaesthesia
- •Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient being in a wheel chair)
结局指标
主要结局
Mobility at 3 weeks post-diagnosis
时间窗: 3 weeks post-diagnosis
Quality of mobilization will be compared using the TUG test. The primary endpoint is TUG at 3 weeks following diagnosis (+/- 3 days) all TUG measurements are assessed by the study nurse.
次要结局
- Activities of Daily Living (ADL) at baseline(baseline)
- Activities of Daily Living (ADL) at 4-7 days after diagnosis(4-7 days after diagnosis)
- Pain (VAS 10) at 3 weeks(3 weeks)
- Activities of Daily Living (ADL) at 12 months(12 months)
- Activities of Daily Living (ADL) at 3 weeks(3 weeks)
- Pain (VAS 10) at baseline(baseline)
- Pain (VAS 10) at 4-7 days after diagnosis(4-7 days after diagnosis)
- Activities of Daily Living (ADL) at 3 months(3 months)
- Number of patients that are able to return to their pre-injury living situation at 3 months(3 months)
- Number of patients that are able to return to their pre-injury living situation at 12 months(12 months)
- Pain (VAS 10) at 3 months(3 months)
研究者
研究点 (2)
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