Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 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
- 否
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.
研究组 & 干预措施
Post-operative knee replacement
Subjects that have had a hemi knee replacement of one knee at least 8 weeks ago had the post-operative knee scanned using the orthopedic hip application and the Lunar orthopedic knee application.
干预措施: iDXA knee software (Device)
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