Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Change of subjective knee status evaluated with EQ-5D
研究概览
简要总结
The purpose of the study is:
- to analyze the success of operative stabilization of the patellar joint with the reconstruction of the medial patellofemoral ligament (MPFL) in terms of the subjective status of the knee, the general quality of life, and physical activity
- to study the influence of specific preoperative (demographic and anamnestic data of the patient, radiological parameters of the knee joint) and intra-operative factors (place of femoral insertion of MPFL graft, patella height, degree of damage to the cartilaginous surfaces of the knee joint) on the subjective outcome of surgical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •patients over 18 years of age
- •surgical intervention with MPFL reconstruction
- •with or without tibial tuberosity transposition (TTT).
排除标准
- •trochleoplasty,
- •corrective knee osteotomy
- •reparative cartilage treatment
- •reconstruction of other knee ligaments
- •meniscus repair
- •movement impairments
- •neuromuscular diseases
- •participation rejection
- •rejection to complete the control questionnaires
- •lack of understanding of the Slovenian language
结局指标
主要结局
Change of subjective knee status evaluated with EQ-5D
时间窗: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with EQ-5D (European quality of life in 5 dimensions; min 0, max 100). Higher scores on the questioner mean a better outcome.
Change of subjective knee status evaluated with KOOS
时间窗: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with KOOS (Knee osteoarthritis outcome score; min 0, max 100). Higher scores on the questioner mean a better outcome.
Change of subjective knee status on Tegner activity scale
时间窗: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Tegner activity scale (min 0, max 10). Higher scores on the scale mean a better outcome.
Change of subjective knee status evaluated with Kujala score
时间窗: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Kujala questioner (min 0, max100). Higher score means a better outcome.
Change of subjective knee status on IKDC
时间窗: 2-8 years
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be assessed with IKDC (International knee documentation committeemin; 0, max 100) questioner. Higher score on the questioner means a better outcome.
次要结局
- Patellar position change(2-8 years)
研究者
Nik Žlak
Principal investigator, Doctor of medicine, PhD student
University Medical Centre Ljubljana