Optimization of Follow-up of Patients With Symptomatic Recent Osteoporotic Vertebral Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Assess life quality of patients with osteoporotic VF 12 months after symptomatic vertebral fracture diagnosis: Quality of life questionnaires (QUALEFFO-41)
研究概览
简要总结
The management of osteoporotic fractures has recently changed with the emergence of new programs dedicated to the diagnosis and treatment of osteoporosis. For example, the Fracture Network of the Paris Saint-Joseph Hospital Group, created in 2015, identifies and ensures the care of patients who have consulted emergency rooms for osteoporotic fractures. Within this sector, the vertebral fracture (VF) appears to be the most frequent (22.4%) ahead of other fracture sites, confirming the results of other studies that consider VF as a real public health problem.
Osteoporotic vertebral fractures (OVF) have certain specificities compared to other osteoporotic fractures, encouraging particular interest.
详细描述
A. Particularities of OVF management
- Pain intensity caused by OVF justifies specific analgesic management. Analgesic management is sometimes complicated by co-morbidities and patients age, with poor analgesics tolerance, in particular opioids.
- OVF is responsible for a change in patients' quality of life, often with a loss of autonomy.
- VF is considered as severe fracture that warrants anti-osteoporotic drug therapy (if osteoporotic origin has been confirmed), in order to avoid risk of a new osteoporotic fracture.
- Progressive profil of pain associated with OVF and importance vertebral extent collapse may justify the use of specific "vertebral augmentation" procedures on vertebra, such as cementoplasty or kyphoplasty. These interventions are aimed at disappearance / reduction of pain related to OVF, improvement of life quality or correction or elimination of a static spinal disorder related to fracture.
B. Current rheumatology OVF management at the GHPSJ Patients management with OVF can be either outpatient or inpatient, depending on the extent of pain, fracture context, and co-morbidities.
- Rheumatology department of the GHPSJ has set up an outpatient patient path dedicated to osteoporotic vertebral fracture, making it possible to optimize patients concerned management. This route has follow characteristics : Patients with OVF are seen by rheumatologist during a consultation dedicated to OVF (Vertebral Fracture Consultation), and benefit the same day from spinal radiographs, bone densitometry and a biological assessment of fragile osteopathy on the GHPSJ site. During consultation, fracture history, risk factors for falls, bone history, an assessment of the patient's pain, functional abilities and life quality are performed. A spinal orthosis can be made if necessary.
Then patients are seen again 15 days later by the same rheumatologist with all results of the assessment During this 2nd consultation, depending on results of the additional examinations and patient's clinical progress, analgesic treatment is adapted. In addition, anti-osteoporotic treatment may be prescribed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patient > 18 years old
- •Patient consulting or hospitalized in the rheumatology department at the GHPSJ for recent and symptomatic osteoporotic spinal or lumbar fracture Recentness is defined either by anamnestic event existence (example: fall) to date the fracture less than 4 months old, or by MRI or CT signs existence of attesting to recent nature of the fracture: hypersignal T2 stir & hyposignal T1 on MRI, presence of a cleft on the CT, on imaging less than 4 months old.
- •Symptomatic is defined as spinal pain existence in relation to the vertebral fracture, not attributable to any cause other than the fracture.
- •Patient affiliated to a health insurance plan
- •Patient capable of giving free, informed and express consent
排除标准
- •Patient with fractures occurring on metastatic spine
- •Patient with unstable VF, requiring rapid orthopedic management
- •Patient with a history of cementoplasty on dorsal or lumbar spine
- •Patients transferred to another hospital after transition to SAU
- •Homeless patient
- •Patient not residing in Ile-de-France
- •Patient who is bedridden or has one or more severe co-morbidity(s) that puts fractured osteoporosis in background
- •Patient deprived of liberty
- •Patient under guardianship or curators
结局指标
主要结局
Assess life quality of patients with osteoporotic VF 12 months after symptomatic vertebral fracture diagnosis: Quality of life questionnaires (QUALEFFO-41)
时间窗: 1 year
Quality of life questionnaires (QUALEFFO-41)
次要结局
- Assess life quality: Quality of life questionnaires (QUALEFFO-41)(2 years)
- Number of new fall(s)(1 year - 2 years)
- Analogical visual scale of patient satisfaction(1 year - 2 years)
- Spinal statics(1 year - 2 years)
- Number of new osteoporotic fractures (vertebral or nonvertebral)(1 year - 2 years)
- Assess pain related to vertebral fracture at D0, M12 and M24 after diagnosis: Analogical visual scale(Day 0 - 1 year - 2 years)
- Measurement of the walking perimeter(Day 0 - 1 year - 2 years)
- Number of hospitalizations for all causes(1 year - 2 years)
- Management of osteoporosis(1 year - 2 years)