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临床试验/NCT05651009
NCT05651009进行中(未招募)不适用

Comparison of the in Vivo Stability of 2 Cementless TKA Designs Using CT Micromotion Analysis - A Randomized Controlled Trial

Helse Møre og Romsdal HF2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
2
主要终点
CTMA Maximum Total Translation

研究概览

简要总结

The goal of this randomized controlled trial is to analyze the stability of a cementless Total Knee Arthroplasty (TKA) over time and compare it to a well-documented implant in patients with knee osteoarthritis. The main aim is to answer if there is a difference in stability over time as a measure of long time survivorship in these 2 implants.

50 participants will be randomly allocated to receive either the Triathlon Tritanium (Stryker) or the Global Medacta Knee Sphere (GMK Sphere, Medacta) 3D printed cementless TKAs.

详细描述

Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both TKA and Total Hip Artrhoplasties (THA) have excellent implant survivorship. However, patients' satisfaction is lower in TKA than THA. A possible cause of the discrepancy is the unnatural knee kinematics after TKA. Various implants designs have been developed to solve the problem. The most common fixation mode is cemented TKA with good survival up to 15 years. However, newer series in younger patients also have shown lasting survival with cementless implants (Nilsson KG, Prudhon JL). Among various different designs, the medially stabilized total knee, which are designed to reproduce natural knee kinematics with a medial ball-in-socked design, is a promising implant design (No authors listed). Dynamically the medial pivot knee performs more naturally (Bragonzoni L,Petersen ET) 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 cementless fixation.

In this study, the investigators will therefore analyze the in vivo stability of an uncemented TKA with a medially stabilized design, and compare it with a well-documented comparable implant. In order to do this, the investigators will use the CT based micromotion analysis (Broden C, Broden C). This study will contribute to the understanding of fixation and lead to safety to the patient.

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
Single (Participant)

盲法说明

Double blinded study (patient and research nurse)

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 Kristiansund Hospital for primary total knee replacement surgery for osteoarthritis with Kellgren & Lawrence grade 3 or 4

排除标准

  • Preoperative severe deformity (Hip-Knee-Ankle angle of >5 (valgus) or <-15 degrees (varus) on a full-length leg image at weight bearing
  • Preoperative flexion contracture more than 15°
  • Less than 50 and 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 or avascular necrosis (e.g. rheumatoid arthritis, tumours)
  • Revision arthroplasty
  • Obesity with BMI>35 g/m2
  • Lateral collateral ligament deficient knee
  • Previous knee joint infection
  • Cognitive dysfunction or severe psychiatric disorders.

研究组 & 干预措施

Control group

Experimental

Cementless Triathlon Tritanium 3D printed TKA

干预措施: TKA (Procedure)

Study group

Experimental

GMK Sphere cementless 3D printed TKA

干预措施: TKA (Procedure)

结局指标

主要结局

CTMA Maximum Total Translation

时间窗: Up to 5 years

The highest total translation on the implant at each time point

次要结局

  • CTMA Total rotation(Up to 5 years)
  • Range of motion(Up to 5 years)
  • HKA(Up to 5 years)
  • The Forgotten Joint Score (FJS)(Up to 5 years)
  • CTMA Total translation(Up to 5 years)
  • The Knee injury and Osteoarthritis Outcome Score (KOOS)(Up to 5 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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