Infrapatellar Fat Pad Excision in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Knee pain
研究概览
简要总结
To examine whether removing the infrapatellar fat pad from the knee during total knee arthroplasty affects the patient outcome in terms of pain and knee function following the procedure. Currently there is no consensus on whether removing this tissue from the knee has a positive or detrimental effect. Small studies have been published, some showing improved symptoms and some worse symptoms. Current practice of orthopaedic surgeons is either to routinely remove or routinely retain the tissue when performing total knee arthroplasty.
详细描述
Aim and Objectives The aim of the study is to examine whether removing or retaining the infrapatellar fat pad influences pain or knee function in the short and medium term.
Study Design A single centre randomized controlled trial of total knee arthroplasty with and without infrapatellar fat pad excision
Methodology A research nurse or the responsible consultant orthopaedic surgeon will identify potentially eligible patients from the list of those invited to attend the pre-operative assessment clinic for total knee arthroplasty. As part of their written invitation to attend this clinic, they will receive an information leaflet about the study from their consultant.
A research nurse or the responsible consultant orthopaedic surgeon will discuss the trial with them at the pre-assessment clinic. If the patient is willing to take part in the study they would then be asked to sign a consent form and will be reminded of the opportunity to withdraw from the study at any point. Their consent will be confirmed on the day of their admission for surgery.
Consented patients will be randomized to one of two arms of the study, the only variable being whether or not the infrapatellar fat pad is excised.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blinded RCT
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/female patients between 40 and 100 years of age
- •Undergoing primary total knee arthroplasty
排除标准
- •Patient undergoing unicompartmental knee arthroplasty
- •Patient undergoing revision knee arthroplasty
- •Patient undergoing arthroplasty using non standard implants
- •Previous patella surgery or injury
- •Cognitive impairment
- •Lack of conversational English
结局指标
主要结局
Knee pain
时间窗: 2 years post-operatively
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Knee pain (Anterior)
时间窗: 2 years post-operatively
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
Knee function
时间窗: 2 years post-operatively
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
次要结局
- Shortening of patellar tendon- comparison between X-ray at 2 years with pre-operative X-ray(2 years post-operatively)
- Knee Range of Movement- flexion and extension in degrees(2 years post-operatively)
- Shortening of patellar tendon- comparison between X-ray at 3 months with pre-operative X-ray(3 months post-operatively)
- Shortening of patellar tendon- comparison between X-ray at 1 year with pre-operative X-ray(1 year post-operatively)