Effect of Excision of the Fat Pad in Total Knee Replacement Surgery. A Randomised Controlled Trial
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
Non removal of fat pad
干预措施: non removal of fat pad (Procedure)
Removal of fat pad
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
