跳至主要内容
临床试验/NCT04037228
NCT04037228招募中不适用

Surgical Outcomes of the Accelerometer-based Navigation System for Total Knee Arthroplasty

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Changes of Radiological Assessments of the knees post-operatively

研究概览

简要总结

Osteoarthritis (OA) is a very common condition in the elderly population. Treatment for end-stage OA is total knee Replacement (TKR)

详细描述

Overall the success rate of TKR is very high with high patient satisfaction and outcomes. Survivorship depends on patient selection and surgical techniques. Femoral and tibial component mal-alignment might lead to early failure.

Although recent studies have questioned the significance of overall postoperative mechanical alignment on survivorship, most studies still demonstrate alignment to be a crucial factor in the clinical success of TKA [1]. Ritter et al [2], in a review of 6070 TKAs, noted the risk of aseptic failure to significantly increase with a tibial component orientation less than 90° relatives to the tibial axis and a femoral component orientation greater than 8° of valgus relative to the femoral axis (failure rate, 8.7%).

Berend et al [3], in a review of 3152 TKAs, demonstrated that a tibial varus alignment of greater than 3° increased the odds of implant failure and medial bone collapse by roughly 17 times.

The most commonly used methods of component alignment in TKA are an extramedullary (EM) alignment guide for the tibial resection and an intramedullary (IM) alignment guide for the distal femoral resection. Unfortunately, these "conventional" methods have demonstrated a limited degree of accuracy for both overall mechanical alignment and individual component Method to create an even more accurate resection includes the use computer-assisted navigation technique. In a meta-analysis of 29 studies comparing computer assisted surgical (CAS) to conventional techniques in TKA (Mason et al). The authors found that only 68.2% of TKAs in the conventional group achieved an overall mechanical axis within 3° of neutral (vs 91.0% in the CAS group), 65.9% achieved a femoral varus/valgus alignment within 2° of perpendicular to the femoral mechanical axis (vs 90.4% in the CAS group) and 79.7% achieved a tibial varus/valgus alignment within 2° of perpendicular to the tibial mechanical axis (vs 95.2% in the CAS group).

However, despite these advantages, concerns regarding increased capital costs, operative times, extra pin sites, and the learning curve associated with the use of CAS techniques have continued to limit its widespread acceptance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Male and female subjects aged over 18 years old
  • All patients must provide their written consent
  • patients with a history of osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis who will receive a primary, posterior-stabilized TKA.
  • All patients should have at least 8 years of school education;
  • Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 or above

排除标准

  • Patients are planned to receive a unicondylar or patellofemoral arthroplasty.
  • Patients with previous cases of alcoholism or drug abuse;
  • Pregnancy and breast-feeding;
  • Presence of serious pathologies;
  • revision surgery
  • Knee infection
  • Non-consenting patients who have not provided the written Informed Consent;
  • Mechanical instability, ligamentous laxity/deficiency and gross deformity

结局指标

主要结局

Changes of Radiological Assessments of the knees post-operatively

时间窗: Through study completion, an average of 1 year

Standing antero-posterior (AP) hip-knee-ankle (HKA) and lateral knee-to-ankle radiographs will be performed to determine the varus/valgus alignment and the posterior slope of the tibial components relative to the mechanical axis.

Changes of Radiological Assessments of the knees at baseline

时间窗: Through study completion, an average of 1 year

Standing antero-posterior (AP) hip-knee-ankle (HKA) and lateral knee-to-ankle radiographs will be performed to determine the varus/valgus alignment and the posterior slope of the tibial components relative to the mechanical axis.

次要结局

  • Knee Functions measure by the Knee Society Score(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ho Ki Wai

Clinical Professional Consultant

Chinese University of Hong Kong

研究点 (1)

Loading locations...

相似试验