跳至主要内容
临床试验/NCT00760188
NCT00760188撤回不适用

Prospective Clinical Evaluation of the Cementless Oxford Partial Knee

Zimmer Biomet1 个研究点 分布在 1 个国家开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Zimmer Biomet
试验地点
1
主要终点
American Knee Society Score

研究概览

简要总结

Prospective data collection on clinical and radiographic outcomes of Cementless oxford Partial Knee.

详细描述

Prospective radiographic and clinical data collection on outcomes of Cementless oxford Partial Knee. Screened radiographs are taken postoperatively and after 12 months. Oxford Knee Scores, SF12 Health Questionnaires and American Knee Society Radiographic Assessment are taken at 12 month follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients undergoing primary knee arthroplasty
  • Patients with one of the following primary diagnoses in the medial compartment of the knee:
  • Osteoarthritis,
  • Avascular necrosis
  • Exclusion criteria:
  • Inability to co-operate with and complete the study.
  • Inadequate fixation of cementless components. If either before or after randomization the surgeon feels that cementless fixation is inadequate, cemented components should be inserted.

排除标准

  • 未提供

结局指标

主要结局

American Knee Society Score

时间窗: 1 yr

The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.

次要结局

  • Short Form 12(1 yr)
  • Oxford Knee Score(1 yr)
  • Radiographic Assessment(1yr)

研究者

发起方
Zimmer Biomet
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验