The WASP Trial (Wiring Versus Anterior Star Plate): Comparison of Patella Plating Versus Tension Band Wiring for the Treatment of Unstable Patellar Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This study aims to compare the efficacy and safety of patella anatomical locking plate fixation versus tension band wiring in the treatment of patellar fractures.
详细描述
Patellar fractures are a common injury that can cause significant pain and disability. Conventional treatment options frequently include tension band wiring (TBW) with or without axial K-Wires or through cannulated screws. However, tension band wiring does have its issues, including implant prominence and frequent reoperation rates, especially for comminuted patella fractures.
More recently, plate fixation has become increasingly more prevalent in the past decade. Initially, this began with small fragment or mini-fragment plates; which progressed to mesh locking plates and now, anatomical locking patella plates. Biomechanical studies have shown greater loads to failure, less fracture gapping or fracture displacement with locking plate fixation compared to TBW. Its low profile construct and round edges may be more tolerable to patients and less prominent than TBW. Furthermore, another possible advantage of plate fixation is the avoidance of quadricep and patellar tendon insertion scarring, as they do not need to be dissected or passed through for fixation as in TBW. This is the first randomized controlled trial comparing anatomical locking plate fixation and conventional tension band wiring for patella fractures to be performed. This study aims to compare the efficacy and safety of these two methods in the treatment of patellar fractures.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are randomly assigned to either one of the interventional arms and will not be informed of the randomization result.
A blinded reviewer will assess the radiographs, surgical quality, and clinical outcomes postoperatively and during study follow-ups.
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
- •Aged 18 years or older
- •Diagnosed with an isolated closed injury, displaced, unstable fracture with displacement >2mm (AO/OTA Classification 34-B and C with surgical indication)
- •Able to give consent
排除标准
- •History of previous knee surgery
- •Poly trauma,
- •Ongoing malignancy
- •Pre-existing severe knee osteoarthritis (>KL stage 4)
- •Other neurological conditions/injuries to the lower limb
- •Unfit for surgical anaesthesia
- •Non-ambulatory
- •Unable to consent or follow commands
结局指标
主要结局
Region specific patient reported functional outcome scores - Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used, and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems), and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Tegner Activity Scale
时间窗: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
The Tegner Activity Scale is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes. Patients are asked to choose the highest level of activity they partake in at that moment.
Tegner Lysholm Knee Score
时间窗: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.
次要结局
- Radiographic outcomes(At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months)
- Incidence of Complications(At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months)
- Subjective Implant Impingement Questionnaire(At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months)
研究者
Prof. Christian Xinshuo Fang
Clinical Assistant Professor
The University of Hong Kong