Prospective, Randomized, Double Blinded Trial Comparing Medial Patellofemoral Ligament Reconstruction (Hamstrings) Versus Campbell Functional Reconstruction (Non-anatomic) in Recurrent Patella Dislocation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Imaging modality X-ray
研究概览
简要总结
This study will compare anatomic Medial Patellofemoral Reconstruction from Hamstring graft with non anatomic reconstruction according to Campbell. The purpose of this study is to evaluate which type of treatment recurrent patella dislocation provides to better clinical, radiological and laboratory outcomes.
详细描述
Recurrent patella dislocation require surgery treatment. It provides to less cartilage degeneration and slow down knee osteoarthritis. Medial retinacular complex is injured in first time patella dislocation and its reconstruction is necessary. In literature there can be found many surgical reconstruction technics: anatomical or non anatomical (functional). But there is lack of evidence which technic provides to better outcomes - reduce the possibility to patella dislocation and progression of osteoarthritis in patellofemoral joint. Nowadays the choice of performed surgery depends on surgeons personal assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recurrent patella dislocation
- •No patellofemoral joint dysplasia or Dysplasia A/B according to Dejour (non operating)
- •Acceptable is to perform concomitant medialization Tibial Tubercle Osteotomy
排除标准
- •no informed consent to participate in the study
- •age under 18 years or above 65
- •multiligament injury or single plane knee instability
- •another musculoskeletal disorders in lower limb
- •lower limb deformity requiring axis correction: valgus
- •femoral anteversion (CT measurements)
- •joints inflammatory diseases
- •concomitant patellectomy or trochleoplasty
- •ASA score > II
结局指标
主要结局
Imaging modality X-ray
时间窗: 2 years
Patellofemoral Joints Biomechanics improvement measured by Q angle
Imaging modality CT
时间窗: 2 years
Patellofemoral Joints Biomechanics improvement measured by Insall-Salvati ratio. The Insall-Salvati ratio or index is the ratio of the patella tendon length to the length of the patella and is used to determine patellar height. he Insall-Salvati ratio was initially determined on a 30° flexed lateral knee x-ray and was later applied to sagittal MRI. Distance lines are used to calculate Insall-Salvati ratio: A: patellar tendon length (TL): length of the posterior surface of the tendon from the lower pole of the patella to its insertion on the tibia B: patellar length (PL): greatest pole-to-pole length Insall-Salvati ratio = A/B (or TL/PL). patella baja: \<0.8 normal: 0.8-1.2 patella alta: \>1.2
次要结局
- Knee Injury and Osteoarthritis Outcome Score(24 months)
- Functional tests(24 months)
- Pain Visual Analog Scale(24 months)
- Knee Injury and Osteoarthritis Outcome Score Patellofemoral(24 months)
- The Victorian Institute of Sport Assessment(24 months)
- International Knee Documentation Committee(24 months)
- Tegner Lysholm Knee Scoring Scale(12 months)
- Pain Visual Analog Scale.(12 months,)
研究者
Rafał Kamiński
Clinical Professor, Head of Knee Surgery Division and Arthroscopy, Department of Trauma Surgery and Orthopedics
Centre of Postgraduate Medical Education