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临床试验/NCT05018507
NCT05018507已完成不适用

NavOne - Variations in Osteoarthritic Knee Laxity Between Individuals and Populations

The Royal Wolverhampton Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2021年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
255
试验地点
1
主要终点
The degree of ligamentous laxity in severely arthritic knees

研究概览

简要总结

Severe osteoarthritis of the knee is a condition associated with severe pain, disability and a loss of independence. The most definitive method of surgical treatment for this condition is total knee arthroplasty (TKA). Total knee arthroplasty aims to provide new metallic bearing surfaces within the knee, in order to alleviate the major source of pain.

Although total knee arthroplasty is an established surgical treatment option, up to 20% of patients may be dissatisfied with the outcome , and many prostheses fail over time, requiring costly revision surgery. Current understanding suggests that soft tissue balancing has a crucial role to play in the outcome of total knee arthroplasty. Instability after total knee replacement is an important cause of failure. It is not clear what the normal collateral ligament laxity should be. There is a paucity of current data on normal knee collateral ligament laxity . Nevertheless, restoring this may improve patient satisfaction with TKA and longevity. It appears that there is considerable variation between individuals, genders , and ethnic groups , when it comes to "normal" laxity. However, much of the existing data relates to healthy young volunteers , and it is not clear how this information should map against the elderly osteoarthritic population who are most likely to be in need of TKA. Recent advances in computer assisted navigation have provided surgeons with a more precise measure of knee alignment , and knee laxity .

Orthopaedic surgeons at New Cross Hospital have been utilising this technology to improve intraoperative placement of total knee replacement implants since 2015. Computer navigation is carried out using the Stryker Precision Navigation System. This system records kinematic and static measurements of knee alignment and laxity in patients just prior to the commencement of the total knee replacement procedure.

By gathering and analysing data from this machine, on the degree of laxity in osteoarthritic patients about to undergo TKA, I this study aims to gain a greater understanding of what can be considered "normal" and whether there are significant differences between individuals, and between ethnic populations in this regard. This will help future surgical decision making about how tight or loose prosthetic knee replacements should be, based on individual characteristics.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All cases of TKA recorded on the 2 Stryker navigation machines based at New Cross and Cannock Chase Hospitals will be included in the study. Duplicates will be identified and removed from the case series.

排除标准

  • Cases in which there is incomplete or inadequate kinematic data recorded in the machine database will be excluded from the study.

结局指标

主要结局

The degree of ligamentous laxity in severely arthritic knees

时间窗: 4 weeks

kinematic and static measurements pre and post op laxity in flexion and extension

Pattern of laxity in relation to pre-existing knee deformity

时间窗: 4 weeks

Establish a pattern of laxity in relation to pre-existing knee deformity

Baseline ligamentous laxity between males and females, and between Caucasian and Asian populations

时间窗: 4 weeks

To compare baseline ligamentous laxity between males and females, and between Caucasian and Asian populations

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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