跳至主要内容
临床试验/NCT05686915
NCT05686915招募中不适用

Metal Artifact Reduction Sequence MRI in Revision Total Hip Arthroplasty With a Ceramic Femoral Head and Titanium Sleeve

Colorado Joint Replacement1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
1
主要终点
MARS MRI abnormalities

研究概览

简要总结

Revision total hip replacement using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in individuals doing well after a revision total hip replacement and ceramic bearing surface that utilizes a titanium sleeve.

详细描述

Metal-on-metal total hip arthroplasty (THA) were heralded as a solution for two of the most common problems in hip arthroplasty in the last decade, instability and osteolysis. Unfortunately, their failures have led to diminished enthusiasm for this bearing surface. Adverse local tissue reactions (ATLRs) have been well documented as a means of pain and failure in this population. A recent report revealed that the most commonly used bearing surface in total hip arthroplasty, metal-on-polyethylene, may have up to a 28% incidence of MRI abnormalities in asymptomatic hips. Revision THA using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in asymptomatic individuals after a revision THA and ceramic bearing surface that utilizes a titanium sleeve. To our knowledge, this has not been studied previously and may provide important baseline features of this diagnostic tool with this particular bearing surface. We hypothesize that there will be fluid collections in a small but clinically significant portion of asymptomatic patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
  • Patient whose age ranges from 18-99
  • Patients who are not experiencing groin pain, thigh pain, or pain with ROM of the hip
  • Patients who are at least 2 years after a revision THA
  • Acetabular implant (cup) was placed in the appropriate position
  • Patients with a Harris Hip Score of >90

排除标准

  • Patients who do not meet the above criteria
  • Patients unable to have an MRI (i.e. pacemaker, metal implants or issues with claustrophobia requiring sedation)

结局指标

主要结局

MARS MRI abnormalities

时间窗: 2 Years Post Revision Total Hip Replacement

Local Tissue Reactions or Fluid collections on the MARS MRI Scan

次要结局

  • Chromium Lab Value(2 Years Post Revision Total Hip Replacement)
  • Titanium Lab Value(2 Years Post Revision Total Hip Replacement)
  • Cobalt Lab Value(2 Years Post Revision Total Hip Replacement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Jennings

Orthopedic Surgeon

Colorado Joint Replacement

研究点 (1)

Loading locations...

相似试验