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临床试验/NCT01352247
NCT01352247已完成不适用

Total or Partial Knee Arthroplasty Trial

University of Oxford2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
2
主要终点
Pain and Function

研究概览

简要总结

In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two different approaches to replacing this arthritic area. Some surgeons feel that it is always best to replace both the knee compartments with a Total Knee Replacement (TKR). Others feel it is best to replace just the damaged component of the knee with a Unicompartmental Knee Replacement (UKR). There is little agreement amongst knee surgeons. Both interventions are established and well documented procedures, yet little evidence exists to support either practice. Each intervention is considered standard care. There exists little evidence, however, to prove the clinical and cost effectiveness of either management option.

The aim of the Total or Partial Knee Arthroplasty Trial (TOPKAT) will be to assess the clinical and cost effectiveness of Total Knee Replacements versus Unicompartmental Knee Replacements in patients with medial osteoarthritis. This will be examined using an appropriate patient base and long term assessments.

The trial has a combined device/expertise based allocation depending on the local situation. Surgeons who are in equipoise and have sufficient experience to perform both TKR and UKR, randomisation and allocation can be based on "device" (UKR or TKR). The same surgeon will perform the operation for both arms of the study.

For surgeons who hold a preference for one treatment over the other, an "expertise" based randomisation will then occur. UKR surgeons will work alongside TKR surgeons. Patients recruited to the study from these sites will be randomised to one of the treatment options and treated by the appropriate surgeon. In such cases the patient is internally referred to the other surgeon's operating list.

Patients will be recruited by their consultant knee surgeons in collaboration with the local research team. TOPKAT are hoping to recruit 500 patients altogether, with 250 per arm of the trial.

详细描述

The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. The randomised controlled trial design will help reduce and prevent potential bias influencing the evaluation.

Participants will be randomised to either UKR or TKR. The trial has a combined equipoise/expertise approach. It enables surgeons who are not in equipoise to deliver only one of the two operations while also allowing surgeons in equipoise to provide both operations. A surgeon who is in equipoise ('equipoise surgeon') and has sufficient experience to perform both TKR and UKR will deliver the allocated operation (UKR or TKR). The same surgeon will perform the operation for both arms of the study.

Not all surgeons are able to exhibit this equipoise. They may hold a preference for one treatment over the other often due to experience/expertise with one type of operation. Interestingly, a surgeon may also believe the patient may benefit from one particular operation even though they may not be able to perform it themselves.

Equipoise is difficult to investigate or establish. Self declaration has been used as the main approach but in order to sufficiently secure this state the following aspects are important:

  • The equipoise considered must be patient- or individual-based equipoise rather than an overall or general category equipoise based on operation type. The surgeon must consider their position for each individual patient. Only if they believe that either operation will be suitable for an individual patient can the patient then be recruited.
  • No surgeon will ever knowingly perform what they consider a substandard surgical procedure.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pain and Function

时间窗: Year 5 (additional extended follow-up to 10 years)

This will be measured by using the Oxford Knee Score, a patient reported outcome questionnaire.

次要结局

  • Range of Motion and Function(Year 5)
  • Economic Evaluation(Year 5 (additional extended follow-up to 10 years))
  • Patient Satisfaction(Year 5 (additional extended follow-up to 10 years))
  • Activity level(Year 5 (additional extended follow-up to 10 years))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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