跳至主要内容
临床试验/NCT02965690
NCT02965690进行中(未招募)不适用

Comparison of in Vivo Kinematics of Different Implants in ACL-sacrificing vs. Medially Stabilized Arthroplasty (Implant Design Study)

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
26
试验地点
2
主要终点
Knee Kinematics measured though all Degrees of freedom (DOF)

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, patient satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implant designs have been developed to solve the problem. However, most of the designs are based on experimental data and not on in vivo kinematics. In this study, we will analyze the in vivo kinematics of the Global Medacta Knee Sphere (GMK Sphere) implant and compare it with a well documented design and implant (NexGen Cruciate Retaining (CR), Zimmer Biomet). We assume our study will contribute to the development of more satisfying knee implants.

详细描述

Worldwide the number of patients requiring treatment for osteoarthritis is increasing due to increasing obesity, an ageing population and a high demanding younger population. Learmonth describes hip arthroplasty as the "operation of the century" because patients are highly satisfied with pain relief and function after the procedure. 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. Reported problems are insufficient function and persistent pain. On the other hand, knee arthroplasties are increasingly implanted in younger and more active patients who require high function and quality of life. Improvement of results after knee arthroplasty is therefore an urgent issue in the field of orthopaedic research.

Knee kinematics and implant designs:

A possible cause of lower function of replaced knees is the unnatural postoperative knee kinematics. The kinematics of replaced knees are closely related to their function. Studies show that replaced knees with excellent flexion angles have kinematic similarities to normal knees and malalignments of implants can cause postoperative pain.

Compared to the hip joint which is a simple ball-and-socket joint, the kinematics of knee is more complex. Native knee kinematics are a combination of a rolling and gliding motion of the femoral condyles and rotation of the tibia, where roll back of the lateral femoral condyle is larger than medially. Roll back is important for high degrees of flexion. Native knee kinematics are not fully understood, but the anterior cruciate ligament (ACL) seems to be an integral part, as knees without a functioning ACL show decreased roll back. 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, but in knee osteoarthritis the ACL and posterior cruciate ligament (PCL) is often deficient as they are damaged by inflammation. Therefore, there are three concepts regarding the retaining of these ligaments in knee replacement surgery. 1: Sacrifice both the ACL and PCL, 2: Retain the PCL (cruciate retaining (CR) design), 3: Retain both the ACL and PCL (bicruciate-reataining design).

The function of the cruciate ligaments can be mimicked by different designs of the tibial insert. The CR design has been widely used in the northern countries, especially the Zimmer Biometri NexGen CR implant in Norway. There are migration data for the NexGen implant with high precision measurements available in the literature. However, the NexGen CR implant does not retain the ACL and does not mimic natural knee kinematics.

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

盲法说明

Non-blind

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 with knee osteoarthritis

排除标准

  • Preoperative severe deformity (Femoro-tibial angle < 175°or > 190° measured on a full-length leg image at weight bearing)
  • Preoperative flexion contracture more than 15°
  • Preoperative limited range of motion under anesthetics (less than 110°)
  • Less than 50 or more than 75 years of age at the time of surgery
  • Use of walking aids because of other musculoskeletal and neuromuscular problems
  • Preoperative diagnosis other than osteoarthritis and avascular necrosis (e.g. rheumatoid arthritis, tumors)
  • Revision arthroplasty
  • Obesity with BMI>35
  • Impaired collateral ligaments
  • Postoperative KOOS score less than 80
  • Malposition of femoral and tibial implants (Internally rotated or more han 10° externally rotated implants will be excluded. The rotation of femoral implant is measured on postoperative CT images in reference to surgical epicondylar line. The rotation of tibial implant is determined according to Berger's measurement)
  • Limb surgery within 3 months before the analysis
  • Postoperative revision surgery due to deep wound infection

结局指标

主要结局

Knee Kinematics measured though all Degrees of freedom (DOF)

时间窗: 1 year

Roentgen Fluoroscopic Stereophotogrammetric Analysis (RFSA). We measure all DOFs (i.e. X-Y-Z rotations and translations in degrees and millimeters respectively)

次要结局

  • Knee Society Score (KSS)(1 year)
  • Forgotten Joint Score 12 (FJS-12)(1 year)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)(1 year)
  • Hip-knee-ankle angle (HKA-angle)(1 year)
  • CT-rotation of implants(1 year)
  • Clinical stability(1 year)
  • Range of motion (ROM)(1 year)

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

PhD, MD, orthopaedic consultant

Oslo University Hospital

研究点 (2)

Loading locations...

相似试验

Kinematics of Contemporary Knee Arthroplasty | 临床试验