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临床试验/NCT01348958
NCT01348958已完成不适用

Evaluation of Orthopedic Knee Measurement Using Lunar iDXA

GE Healthcare2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
GE Healthcare
入组人数
36
试验地点
2
主要终点
Efficacy of Lunar orthopedic knee software.

研究概览

简要总结

This study is to compare scans of the knee performed using new software designed specifically to look at the knee joint with those performed using approved software designed for scans of the hip.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Adult (>30 years) males and females.
  • Have had a hemi knee replacement of one knee at least 8 weeks ago.
  • Patello-femoral osteoarthritis is not a contraindication if person does not have symptoms from the patello-femoral joint.
  • Able to provide informed consent.
  • In good general health.

排除标准

  • Neuromuscular or vascular disease in the affected leg.
  • Found to be unsuitable for hemi knee arthroplasty (KA) before or at surgery.
  • Preoperative extensions defect greater than 15 degrees.
  • Preoperative maximal flexion of less than 100 degrees.
  • Symptomatic patello-femoral osteoarthritis.
  • Insufficiency of anterior cruciate ligament (ACL)
  • Fracture sequalae (Intraarticular fracture and all tibial condyle fractures).
  • Previous osteotomy.
  • Previous extensive knee surgery.
  • Metabolic bone disease including osteoporosis with a T score of <-2.
  • Rheumatoid arthritis.
  • Postmenopausal women on systemic hormone replacement therapy (HRT).
  • Long-term treatment with oral corticosteroids and/or bisphosphonates.
  • Inability to consent (such as Alzheimer's Disease).
  • Misuse of drugs or alcohol.
  • Serious psychiatric disease.
  • Disseminated malignant disease and treatment with radiotherapy or chemotherapy.

结局指标

主要结局

Efficacy of Lunar orthopedic knee software.

时间窗: 5 months from starting study.

This study will compare the bone density and bone mass measurements acquired with Lunar orthopedic knee software and for the same scans acquired with Lunar orthopedic software. A determination of precision of bone measurements acquired and analyzed with Lunar orthopedic knee software.

次要结局

未报告次要终点

研究者

发起方
GE Healthcare
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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