The Faroese Knee Cohort: An Investigation of Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Severity of patellar dislocations
研究概览
简要总结
The investigators intend to establish a national cohort including all persons in the ages from 15-20 years old with patellar instability (PI) or a prior knee injury (ACL-ruptur or meniscus damage) . The cohort will be nicknamed "The Faroese Knee Cohort".
The overall aim is to investigate two groups.
- The patella instability group, in which we intend to investigate the following.
- Prevalence of patellar dislocation and trochlear dysplasia in the Faroe Islands.
- Risk factors for patellar dislocations-
- Heredity of trochlear dysplasia.
- If there is a specific gene responsible for the development of trochlear dysplasia.
- The development of retropatellar artrhosis, its onset and its impact on quality of life and function,
- Knee injury group (ACL-ruptur or meniscus injury)
- The prevalence of ACL-rupture and/or meniscus injury in this specific group in the Faroe Islands.
- The impact on quality of life and function.
详细描述
The Faroese Knee Cohort aims to consist of all persons in the Faroe Island between 15-20 years old with patellar instability* (PI) or a knee injury.
Special focus will be on PI, Patella dislocation (PD) and Trochlear Dysplasia (TD), a condition where the femoral trochlea has a dysplastic shape and lacks the lateral support of the patella. The diagnosis will be set by MRI of the knees and is in this study defined as the presence of one of the following: Crossing sign on a true lateral x-ray, lateral trochlear inclination angle < 11 degrees or a trochlear depth < 3 mm.
The hypothesis is that abnormal values in the following measures will be associated with increased risk of patellar dislocation and worse patient reported outcome: Caton-Deschamps index, Lateral Trochlear Inclination, Trochlear Facet Asymmetry, Trochlear Depth, Tuberostias Tibia - Trochlear Groove distance, Patello-trochlear index and Tuberositas Tibia - Posterior Cruciate Ligament distance.
Furthermore, we expect pivoting sports to be a behavioral risk factor.
The primary endpoint is measured by the number of patellar dislocations or near-dislocation the patient experiences (daily, weekly, monthly, yearly).
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
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 15-20 years at the start of patient enrolment.
- •The feeling of patellar instability, or patellar dislocation/near-dislocation.
- •The person has to be from the Faroe Islands.
- •All persons under the age of 18 must get written consent by their parents
排除标准
- •Terminal illness
- •Mental disabilities and illness, meaning that the patient cannot independently answer the PROM´s and cooperate to the clinical investigation.
结局指标
主要结局
Severity of patellar dislocations
时间窗: 1 year
The severity of PD defined by number of PD or near-dislocations the patient experience (daily, weekly, monthly, yearly).
次要结局
- Risk factors for patellar dislocation 3(1 year)
- Risk factors for patellar dislocation 1(1 year)
- Risk factors for patellar dislocation 2(1 year)
- Risk factors for patellar dislocation 4(1 year)
- Risk factors for patellar dislocation 6(1 year)
- Patient reported activity(1 year)
- Patient reported luxation score(1 year)
- Risk factors for patellar dislocation 5(1 year)
- Patient reported patellofemoral pain(1 year)
研究者
Kristoffer Barfod
MD. Ph.D. Associate Professor
Hvidovre University Hospital