Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Proportion of patients that are using the braces
研究概览
简要总结
The study is a non-controlled retro- and prospective multi center patient registry study.
Subjects will be given a study ID number assigned at first brace fitting after consenting to partake. Participants will be asked to fill in a questionnaire either in electronic or paper version at first fitting. Additional follow up questionnaires will be implemented at 4 weeks, 6 months and 1 year post initial brace fitting. After that period patients will be contacted every year, until brace termination/ knee surgery or death.
详细描述
This is a noninterventional registry study pertaining to knee OA braces. There are no comparative devices or treatments. Subjects are expected to follow the recommendations of the brace subscriber and other health care professionals at any time independent of their continuation within the registry.
Subjects will be enrolled at the clinic where their brace was prescribed or at the site where the brace was fitted.
There is no formal end date for this data registry. A revisit to this protocol may be motivated after 5 years, to assess if longer follow up is required.
For individual participants follow up will continue with annual questionnaires as long as the brace is in use. The questionnaires will be administered either through mail with a paper version, or through a link to an electronical version (ePRO). There is also a possibility of administrating the questionnaires as a phone guided interview, if that is a mean that serves the patient or clinics better. The planned follow-ups are at 4 weeks, 6 months, 1 year from brace prescription and then annually as long as participants are disposed as "ongoing" in the registry.
The questionnaires contains question about pain, function, medication, general brace use and quality of life question.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are prescribed knee brace for symptomatic treatment of knee OA from partaking clinics
- •Older than 18 years
排除标准
- •Younger than 18 years
- •Not willing or able to sign informed consent, or not cognitive impairments preventing understanding of the questionnaires.
结局指标
主要结局
Proportion of patients that are using the braces
时间窗: 6 months follow up
brace usage, days per week
Change in Pain status compared to baseline
时间窗: 1 year follow up
KOOS-12
Change in Mobility compared to baseline
时间窗: 1 year follow up
KOOS-12
Proportion of patients that are still using the braces
时间窗: 1 year follow up
brace usage, days per week
Sick leave after receiving the braces
时间窗: 1 year follow up
Proportion of sick leave
Changes in reported quality of life
时间窗: 1 year follow up
KOOS-12
Changes in QALY's
时间窗: 1 year follow up
EQ-5D-5L
次要结局
未报告次要终点
