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临床试验/NCT01407042
NCT01407042已完成不适用

Patellofemoral Pain After Unicondylar Knee Arthroplasty

Medical University Innsbruck1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年9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
入组人数
24
试验地点
1
主要终点
KOOS questionnaire changes

研究概览

简要总结

Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. Two different types of UKA design are available - both with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an additional amount of cartilage and bone close to the implantat. It is unclear whether this is of clinical relevance.

We speculate that the amount of cartilage/bone removal is related to the clinical outcome of the UKA-surgery.

In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured during the surgery. The clinical success of the procedure will be determined with certain knee questionnaires (Kujala & KOOS)preoperatively, 3 months postoperatively, 6 months postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.

The three variables (removed amount of cartilage/bone; clinical success with regard to the questionnaires; bone remodelling) are then analyzed with statistical methods to find out potential assoziations among them.

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

  • osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment

排除标准

  • failed upper tibial osteotomy
  • insufficiency of the collateral or anterior cruciate ligaments
  • a fixed varus or valgus deformity (not passively correctable) above 15°
  • a flexion deformity greater than 15°
  • rheumatoid arthritis

结局指标

主要结局

KOOS questionnaire changes

时间窗: -1 days, 3 months, 6 months, 1 year

Size of anterior femoral notch

时间窗: day 0

Required cartilage / bone removal adjacent to the femoral implant

Kujala Score changes

时间窗: -1 days, 3 months, 6 months, 1 year

Radionuclide tracer uptake at the surgically created notch

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Liebensteiner

MD, PhD

Medical University Innsbruck

研究点 (1)

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