Study of Osteogenesis Imperfecta Tendon and Ligament: Retrospective and Prospective Assessment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Tendon stiffness
研究概览
简要总结
Osteogenesis imperfecta (OI) is a rare genetic disease due to a mutation in one of the genes encoding either type I collagen or a protein involved in its synthesis. This leads to bone fragility with fractures and deformities. However, other tissues rich in type I collagen can also be affected, such as teeth or vessel walls.
In the literature, several case reports describe tendon ruptures in OI patients, but no original study has really addressed this issue, which is likely to impact the quality of life through a reduction in mobility and pain.
Recent work carried out by the investigators shows an alteration of the osteotendinous unit in the osteogenesis imperfecta mouse (oim), a validated model of the most severe form of OI. Consequently, the project aims to study the damage of tendon and ligament in patients suffering from osteogenesis imperfecta.
详细描述
This project aims to study the damage of tendon and ligament in a cohort of patients suffering from osteogenesis imperfecta. The data collected will be put into perspective with those of our first experimental work on mice. They will also make it possible to complete the specific care of these patients. Indeed, during the anamnesis, particular attention will be paid to the description of tendon-ligament pain in order to propose the most effective treatment for this kind of disorder, mainly in physiotherapy. Prevention work will surely be necessary with patients and caregivers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to have an osteogenesis imperfecta
排除标准
- •none, since we want to study different types of osteogenesis imperfecta and consider the effect of age.
结局指标
主要结局
Tendon stiffness
时间窗: Throughout the entire study, approximately during 22 months
Triceps suralis tendon, from zero to infinity, expressed in Newton/mm², a high value indicates a high stiffness
次要结局
- Kinesiophobia(Throughout the entire study, approximately during 22 months)
- Quality of life for adults(Throughout the entire study, approximately during 22 months)
- Quality of life for children(Throughout the entire study, approximately during 22 months)
- Grip strength test(Throughout the entire study, approximately during 22 months)
- Pain localization and intensity for adults(Throughout the entire study, approximately during 22 months)
- Mobility : walking test(Throughout the entire study, approximately during 22 months)
- Pain localization and intensity for children(Throughout the entire study, approximately during 22 months)