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临床试验/NCT04017533
NCT04017533已完成不适用

In Vivo Stability of an Uncemented Total Knee Arthroplasty With Medially Stabilized Design

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
MTPM

研究概览

简要总结

Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patients' satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implants designs have been developed to solve the problem. The most common fixation mode is cemented TKR with good survival up to 15 years. However, newer series in younger patients also have shown lasting survival with uncemented implants (Nilsson et al 2006, Prudhon et al. 2017). Among various different designs, medially stabilized total knee, which are designed to reproduce natural knee kinematics with medial ball-in-socked design, is a promising implant (Australian registry report 2018). Dynamically the medial pivot knee performs more naturally (Bragnazoli et al, 2019) compared to other designs. Most data for this design is available only for the cemented version. Up to now there is no safety study performed that confirms the stability over time for this implant with uncemented fixation.

In this study, we will therefore analyze the in vivo stability of an uncemented knee implant with medially stabilized design. Our study will contribute to the understanding of fixation and lead to safety to the patient.

详细描述

Worldwide the number of patients requiring treatment for osteoarthritis is increasing (Kurtz et al. 2007). Especially the young population will increase within the group of patients for arthroplasty (Kurtz et. al. 2009). Learmonth describes hip arthroplasty as the "operation of the century" because patients are highly satisfied with pain relief and function after the procedure (Learmonth et al, 2007). Knee arthroplasties have in recent years also shown promising results and have surpassed hip arthroplasty in frequency in western countries. However, patient satisfaction is not as high (Dieppe et al. 2012, Carr et al, 2013). Reported problems are insufficient function (Hawker et al. 2013) and persistent pain (Wylde et al. 2012). On the other hand, knee arthroplasties are increasingly implanted in younger and more active patients (Rabi et al. 2012, Ibrahim et al. 2010) who require high function and quality of life. Improvement of knee implants is an urgent issue in the field of orthopedic research.

Knee Kinematics and implant designs

A possible cause of lower function of replaced knees is the unnatural postoperative knee kinematics. Kinematics of replaced knees is closely related to their function. For example, replaced knees with excellent flexion angles have kinematic similarities to normal knees (Watanabe et al. 2013) and malalignments of implants can cause postoperative pain (Bell et al. 2014).

Compared to hip joints, which are simple ball-and socket joints, the kinematics of knee joints is more complex. It is a combination of rolling and gliding motion of femoral condyles and rotation of tibia (Smith et al. 2003). Based on the kinematics of the normal knee joint, various attempts have been made on the design of knee implants to reconstruct normal kinematics after replacement surgery. In healthy knees the contributing anatomical structures for knee kinematics are two cruciate ligaments (anterior cruciate ligament; ACL, and posterior cruciate ligament; PCL) inside the joint (Figure. 1). However, in knees with osteoarthritis, ACL may be degenerated by inflammation and often not deserve retaining. Therefore, the majority of total knee implant designs sacrifices ACL. Instead, various attempts have been made on implant design to develop knee implants with increased stability.

One of the designs is PCL-retaining (CR) knee with extended posterior femoral radius in flexion to provide greater femoral/tibial contact area in high flexion. This implant design allows for PCL retention and theoretically enhances antero-posterior rollback. CR knees are widely used for many decades and various implants with this design are available. Although they have favorable clinical results in the point of survivorship (Chalidis et al. 2011), CR knees do not reproduce femoral rollback during flexion in vivo (Watanabe et al. 2013).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to Oslo University Hospital, Ullevål for knee replacement surgery will be included to this study for a total of 30 subjects.

排除标准

  • 75 and more years of age at the time of surgery
  • Use of walking aids because of other muscoloskeletal and neuromuscular problems
  • Preoperative diagnosis other than osteoarthritis and avascular necrosis (e.g. rheumatoid arthritis, tumors)
  • Obesity with BMI>35
  • Lateral collateral ligament deficient knee
  • Reduced bone quality in the proximal tibia before surgery
  • Insufficient language to answer questionnaires in Norwegian

结局指标

主要结局

MTPM

时间窗: 2 years

Maximum Total Point Motion in mm

次要结局

  • Segmental RSA(2 years)
  • DEXA of the proximal tibia(2 years)
  • Conventional radiography(2 years)
  • Forgotten Joint Score (FJS)(2 years)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)(2 years)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan M Rohrl

ass.professor

Oslo University Hospital

研究点 (2)

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