Utility of the Variable Angle LCP Patella Plating System for Traumatic Patellar Fractures: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison
研究概览
简要总结
The Depuy Synthes Locking Compression Plate (LCP) Variable Angle Patella Plating System is an FDA approved device. The purpose of this study is to see how well the Depuy Synthes LCP Variable Plating System work in fixing a broken kneecap (patella). Depuy says that the device will improve healing when compared to traditional ways of repairing a broken patella.
The goal of this randomized control trial is to learn how well the LCP Variable Plating System works to fix a broken patella (kneecap) compared to traditional fixation methods, in male and females, age 18 to 74, with a patellar fracture, and being treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital. The main question it aims to answer are:
- To understand if the Depuy Synthes LCP Variable Angle Plating System will provide a better way to help patients recover from a broken patella.
Participants will evaluated at specific time points: post-op day 1, 6 weeks, 3 months, 6 months, and 12 month post-surgery. Participants will be asked to:
- Complete surveys at all evaluation timepoints.
- Have x-rays(radiographs) taken at the 6 week, 3 month, 6 month, 9 month, and 1 year timepoints.
- Participants will have a passive range of motion tests done at 6 week, 3 month, 6 month, 9 month, and 1 year timepoints.
- Participants would have strength and balance tests done at the 3 month, 6 month, 9 month, and 1 year timepoints.
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
- Single (Participant)
盲法说明
It insures unbiased patient reported outcomes in data collection, the participants are blinded to what arm they are put in.
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Age between 18 and 74 years old (inclusive)
- •Patellar fracture
- •Treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital
排除标准
- •Age greater than or equal to 75 or less than 18
- •Patients that are non-ambulatory/limited ambulation prior to their injury
- •Previous patellar fracture
- •Pre-existing osteoarthritis of the knee
- •Ipsilateral femoral or tibia fractures
结局指标
主要结局
DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison
时间窗: 1 year
Comparing the DePuy Synthes LCP Variable Patella Plating System to tradition fixation methods using clinical outcomes measures.
DePuy Synthes LCP Variable Angle Patella Plating System functional outcomes comparison
时间窗: 1 year
Comparing the DePuy Synthes LCP Variable Patella Plating System to traditional fixation methods using functional outcomes measures.
DePuy Synthes LCP Variable Angle Patella Plating System patient reported outcomes comparison
时间窗: 1 year
Comparing the DePuy Synthes LCP Variable Angle Patella Plating System to traditional fixation methods using patient/participant reported outcomes measures.
次要结局
- Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)(1 year)
- Radiographs(1 year)
- Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)(1 year)
- Strength(1 year)
- Passive Range of Motion (ROM)(1 year)
- Balance(1 year)
研究者
Michael Miranda
Clinical Professor
Hartford Hospital