Difference in Patient Reported Outcomes and Patellar Tracking Before and After MPFL Reconstruction With or Without Tibial Tuberosity Transposition
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in patient-reported outcomes.
研究概览
简要总结
Patellar dislocations cause pain and functional decline in adolescents, which can be restored by a MPFL reconstruction with or without tibial tuberosity transposition. Yet, many reconstruction methods are being used clinically as consensus on the ideal MPFL reconstruction method is lacking. We propose a soft-tissue loop reconstruction method which potentially decreases the risk for of iatrogenic fracture of the patella and prevents femoral tunnel malposition.
详细描述
Rationale: A patellar dislocation is one of the most common acute knee disorders in children and adolescents, causing pain and functional decline. In order to restore healthy kinematics and relieve pain, patients can receive a MPFL reconstruction. Still, there is no consensus on the ideal MPFL reconstruction method. Within the Radboudumc, a dynamic soft-tissue loop method is used for MPFL reconstruction. The method minimizes the risk of iatrogenic fracture of the patella and prevents nonanatomic tracking due to femoral tunnel malposition. Yet, the technique has not been evaluated clinically.
Objective: Evaluate pre- and postoperative reported outcomes in patients receiving an soft tissue loop MPFL reconstruction for the treatment of patellar instability. Additionally, it is aimed to investigate the difference in patella tracking before and ~12 months after surgery measured with 4D CT imaging in patients receiving an MPFL reconstruction with or without TTT for the treatment of patellar instability.
Study design: Prospective single centre observational study.
Study population: 20 patients with recurrent patellofemoral instability who have received or will receive an soft-tissue loop MPFL reconstruction with or without TTT within the Radboudumc.
Main study parameters/endpoints: the main study parameter is the pre- and postoperative difference in patient reported outcome measures (PROMs). The secondary aim is to assess changes in patellar tracking (measured before and 12 months (to ~ 24 months) after surgery).
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 16 years and older.
- •Recurrent patellofemoral instability, for which:
- •the patient will receive a MPFL reconstruction with or without TTT, or
- •the patient has received a MPFL reconstruction with or without TTT , on the condition that the patient has a usable preoperative 4D CT scan.
- •Informed consent of the patient.
排除标准
- •Patients below an age of 16 years.
- •Patients that are pregnant.
- •BMI > 35
- •Patients that are unable to actively flex and extend their knee.
- •Patellar stabilizing surgery other than the usual MPFL reconstruction with or without TTT. This includes: trochleoplasty, static MPFL reconstruction, isolated TTT
结局指标
主要结局
Change in patient-reported outcomes.
时间窗: 6 weeks preoperative to 12 months postoperative
Pre- and postoperative difference in patient reported outcome measures (PROMs)
Change in patient-reported outcomes
时间窗: 6 weeks preoperative to 6 months postoperative
Pre- and postoperative difference in patient reported outcome measures (PROMs)
次要结局
- Difference in patellar tracking.(preoperative, 12-~24 months postoperative)