跳至主要内容
临床试验/NCT04597684
NCT04597684终止不适用

What Are the Results of Cemented vs. Cementless TKA With the Same Implant Design? A Randomized Clinical Trial.

OrthoCarolina Research Institute, Inc.1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2020年9月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
1
主要终点
Revision for loosening

研究概览

简要总结

The investigators are evaluating an implant (Depuy Attune TKA) that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options. The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant.

详细描述

Aseptic Loosening remains a leading cause for revision following TKA. Cemented TKAs have shown high failure rates in obese and younger populations. There is renewed interest in biologic fixation of total knee components with a more active and younger patient population, as well as long term alternatives in obese patients receiving TKA.

Questions remain whether cemented or cementless long term fixation is superior in total knee arthroplasty in these populations.

Potential benefits of cementless fixation include preservation of bone, decreased operative times, and elimination of complications specific to cemented components. Older cementless TKA designs had higher failure rates due to poor fixation methods, patch porous coating on the implant, poor tibial locking mechanisms and the use of conventional polyethylene. The combination of these factors led to unacceptable failure rates in these devices. Newer designs have looked to improve these flaws with advances in the biologic interface, use of highly porous metals, improved locking mechanisms, and cross-linked polyethylene.

Recently, cementless implants with these improved design features have shown improved long term outcomes of cementless components versus their cemented predecessors. The combination of these improved long term outcomes in younger, more active population warrant further investigation of cementless components in TKA. There is a need for more durable, long term fixation in all implants treating obese, as well as young active patients.

The investigators are evaluating an implant (Depuy Attune TKA) that was recently released to market with a cementless design that is yet to have long term comparative data between this cementless design or cemented options. The investigators are conducting a study to compare the results of this cementless design to the cemented design of the same implant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Evaluation for TKA at OrthoCarolina
  • •Evaluated and scheduled for TKA by Drs. Keith Fehring, Bo Mason, William Griffin, Thomas Fehring, or Jesse Otero
  • •Determined by the above surgeon to be a candidate for the Attune Posterior Stabilized knee system, with the patella to be resurfaced during surgery
  • •>18 years of age at enrollment

排除标准

  • •Previous surgery with hardware on the joint of interest
  • •>= 65 years old at the time of TKA surgery
  • •Previous diagnosis of inflammatory disease (RA, inflammatory arthropathy, any autoimmune disease)
  • •Physician discretion due to not being able to follow standard-of-care (SOC) TKA follow up protocol
  • •History of contralateral TKA
  • •Current Tobacco Use

研究组 & 干预措施

Treatment/Intervention

Active Comparator

Total Knee Arthroplasty (TKA) with cementless knees

干预措施: Cementless Total Knee Arthroplasty (Procedure)

Control

Active Comparator

Total Knee Arthroplasty (TKA) with cemented knees

干预措施: Cemented Total Knee Arthroplasty (Procedure)

结局指标

主要结局

Revision for loosening

时间窗: Within 20 years of study surgery

Did the subject have a revision procedure due to loosening (yes/no)

次要结局

  • Radiographic evidence of loosening(PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year)
  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.)(PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year)
  • The Veterans RAND 12-Item Health Survey (VR-12)(PreOperative, 3 months, 6 months, 1 year, 2 year, 5 year, 10 year, 15 year, 20 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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