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临床试验/NCT01138696
NCT01138696已完成不适用

Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for ACL Repair

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
to determine the evolution in pain, safety and tolerability of replacement of anterior cruciate ligament (ACL) after trauma or injury

研究概览

简要总结

About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the repairing and replacement of injuries of the anterior cruciate ligament. After less than 10 years it appeared that a relatively important number of patients showed complications on the basis of synovitis. The situation of another group of patients on the other hand evolved favourably without complications. The study to focuses on this group of patients and attempts to determine how the replacement without problems ab initio, evolved in the time.

It concerns a group of 57 patients who received an implantation in the UZ Ghent between November 85 and October 87 with the Stryker Dacron ligament and a group of 33 patients who received the Trevira ligament in the ASZ Aalst. The clinical result will be stipulated by means of standardized questionnaires and a clinical examination. The radiological result will be determined by the degree of integrity of the ligament that was implanted at the time. In this way the study could give an idea about the degree in which the technical success of the intervention correlates with the clinical success 20 years later.

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
49 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
  • Max age: 75
  • Min age: 49
  • Minimum follow up: 22 years

排除标准

  • 未提供

结局指标

主要结局

to determine the evolution in pain, safety and tolerability of replacement of anterior cruciate ligament (ACL) after trauma or injury

时间窗: 20 years after surgery

Pain is measured by the VAS-score. For the evaluation of safety and tolerability the patients fill in the Tegner, Lysholm, IKDC, KOOS and SF-36 questionnaires

次要结局

  • A clinical and radiographical evaluation of the knee after implantation of a synthetic ligament.(20 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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