TENSION BAND VERSUS LOCKING PLATE FIXATION FOR THE TREATMENT OF PATELLA FRACTURE - a High Quality, Multicenter, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 6
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score - (KOOS5)
研究概览
简要总结
This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures.
详细描述
This study is a multicenter pragmatic, prospective, assessor-blinded, randomized independent clinical trial in which we compare locking plate fixation to standard tension band fixation in patients with patella fractures.
Primary objective The overall objective of the study is to compare the 1-year patient-reported Knee Injury and Osteoarthritis Outcome Score (KOOS5) after standard tension band fixation with locking plat fixation for patients with patella fractures.
Secondary objectives Several other analyses are of interest and are planned but are not objectives of this study. Therefore, these analyses will, for the major part, hypothesis-generating. Analyses of this type include, but are not limited to harms, muscle atrophy, pain, general health, gait function, time to return to work and economical consequences between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Due to the surgical nature of the study the surgeon can not be blinded. The outcome assessor, patients and care providers will be blinded with regards to the two treatment groups.
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
- •Above 18 years of age
- •Patella fracture suitable for surgically treatment, with both surgical methods
- •AO classification 34-B, 34-C
排除标准
- •Open patella fracture above Gustillo grade 2
- •Bilateral patella fracture
- •Total knee replacement in the affected extremity
- •Other fractures of the affected extremity within the previous 12 months.
- •Other reasons for exclusion (unable to understand Danish, mentally unable to participate, etc).
- •Prior ipsilateral patella fracture
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score - (KOOS5)
时间窗: One year following treatment
The Knee Injury and Osteoarthritis Outcome Score (KOOS) 29 is a standardised patient-reported questionnaire developed to evaluate knee problems. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL and an overall score KOOS5 can be calculated. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
次要结局
- EQ-5D-5L questionnaire (5-level version)(3-, 6- and 12-months)
- Pain intensity measured on a 10 cm VAS scale(3-, 6- and 12-months)
- Bone union(3-, 6- and 12-months)
- Knee Injury and Osteoarthritis Outcome Score - subscales: pain, ADL, symptoms, sport and QOL.(3-, 6- and 12-months)
- Knee Injury and Osteoarthritis Outcome Score - (KOOS5)(3- and 6 months)
- "PainDETECT" questionnaire(3-, 6- and 12-months)
- Maximum isometric knee-extension strength(12-months)
- Maximum isometric knee-flexion strength(12-months)
- Knee range of motion(3-, 6- and 12-months)
- Time to return to work(3-, 6- and 12-months)
研究者
Rasmus Elsøe
Head of orthopaedic trauma surgery
Aalborg University Hospital