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临床试验/NCT02861794
NCT02861794已完成不适用

Evaluation of Early Migration of Medially Stabilized Arthroplasty as a Predictor of Long Time Survivorship (Implant Design Study)

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年5月1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
44
试验地点
2
主要终点
Stability of the GMK Sphere prosthesis measured by Radiostereometric Analysis (RSA)

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 implants designs have been developed to solve the problem. However, most of their designs are based on experimental data and little has been studied about their actual performance in vivo. In this study, the investigators will analyze the in vivo stability of the Global Medacta Knee Sphere (GMK Sphere) implant. Migration of the implants will be monitored with a high precision measuring method called Radiostereometric Analysis (RSA). The investigators assume the investigators study will contribute 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 knee implants is 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. Kinematics of replaced knees is 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 hip joints which are simple ball-and socket joints, the kinematics of knee joints is more complex. The kinematics are a combination of a rolling and gliding motion of the femoral condyles and rotation of the tibia. 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. All of these implants have satisfying survivorship, but unicondylar arthroplasty which retains both cruciate ligaments has the best clinical results with survivorship at 15 years 93%. In total knee replacement (TKR) the Anterior Cruciate Ligament (ACL) and possibly the Posterior Cruciate Ligament (PCL) are sacrified. When sacrificing the one or both of the cruciate ligaments, natural knee kinematics are affected. The function of the cruciate ligaments can be mimicked by different designs of the tibial insert.

The most used knee implant in Norway, the NexGen Cruciate-retaining (CR) implant design, does not retain the ACL and does not mimic natural knee kinematics. The tibial insert of the medial pivot implant design (GMK Sphere) has a constrained medial ball in socket joint and at the same time allows lateral anterioposterior movement. This new design was developed by a group of dedicated researchers. The design intention is to resemble the function of the cruciate ligaments and at the same time allow for lateral anterioposterior movement (rollback).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
  • Malposition of femoral and tibial implants (Internally rotated or more than 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)
  • Postoperative revision surgery due to deep wound infection

结局指标

主要结局

Stability of the GMK Sphere prosthesis measured by Radiostereometric Analysis (RSA)

时间窗: 5 years

Stability of the implant is measured in mm after 5 years (Maximum Total Point Motion in mm, MTPM)

次要结局

  • Knee injury and Osteoarthritis Outcome Score (KOOS)(5 years)
  • Forgotten Joint Score 12 (FJS-12)(5 years)
  • Hip-knee-ankle angle (HKA-angle)(5 years)
  • Stability of the GMK Sphere prosthesis(5 years)
  • Knee Society Score (KSS)(5 years)
  • Range of motion (ROM)(5 years)
  • CT-rotation of implants(5 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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