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临床试验/NCT04503512
NCT04503512已完成不适用

Effect of Excision of the Fat Pad in Total Knee Replacement Surgery. A Randomised Controlled Trial

Liverpool University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2012年10月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
1
主要终点
Koos Knee Score

研究概览

简要总结

Introduction:

The infrapatellar fat pad (Hoffa's fat pad) is a structure which is located intra-articularly. Its function is not well known. During knee replacement surgery, some surgeons would prefer removing the whole of the fat pad as this can improve exposure of the knee joint, as it can affect exposure of the knee joint which will in turn make the procedure slightly more efficient. Other surgeons would rather resect the minimum amount and preserve the bulk of the structure as anecdotally this is thought to decrease the level of post operative pain. This surgical step fat pad resection is a very small part of the whole total knee replacement procedure.

A previous retrospective review of patients whose fat pad had been removed showed that they were nearly twice as likely to experience postoperative pain (P = 0.0005), while another study showed that they are at a slight risk of patellar tendon shortening.

A randomised controlled trial of 68 patients did not show any difference in patella tendon length at six months and no difference in pain relief in both groups 3. However this study did not evaluate the functional outcome in both groups.

To our knowledge, there are no RCT looking at the effect of the excision or preservation of the fat pad in TKR and the functional outcomes post operatively.

Study Hypothesis:

Excision of Hoffa's fat pad during total knee replacement surgery does not affect functional outcome, pain level after surgery or the patella tendon length at either one or two years.

详细描述

RCT of excision or preservation of fat pad in TKR and the functional outcomes post operatively

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, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •1- Primary total knee replacement for knee osteoarthritis

排除标准

  • •Revision Surgery.
  • •Primary Knee Replacement for pathologies other than Osteoarthritis.
  • •Previous knee fractures around the knee.
  • •Previous confirmed intra-articular infections.
  • •Non English speaking/reading patients.

研究组 & 干预措施

Non removal of fat pad

Active Comparator

Non removal of fat pad

干预措施: non removal of fat pad (Procedure)

Removal of fat pad

Active Comparator

Removal of fat pad

干预措施: removal of fat pad (Procedure)

结局指标

主要结局

Koos Knee Score

时间窗: 3 months post op,

The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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