NL-OMON47627已完成不适用
Dynamic Intraligamentairy Stabilisation of the acute torn anterior cruciate ligament, a multicenter prospective cohort study. - Ligamys Trial
Xpert Orthopedie0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Acute primary rupture of the anterior cruciate ligament
- •* Signed patient informed consent
- •* Willingness to present for follow-up
- •* Age between 18 and 50 years at the time of inclusion in the study
- •* Injury - surgery time interval of 21 days or less
- •* BMI <35
- •* Tegner score 6 or more
排除标准
- •* Co-morbidity influencing the outcome of the implant.
- •* Hypersensetivity to metals.
- •* Not being able to fill in the Dutch Questionnaires.
- •* Osteo arthritis Kelgren grade 2 or more on conventional x-ray
- •* Medical non-compliance
- •* Unwillingness to follow the rehabilitation programme
- •* Traumatic cartilage lesion requiring cartilage repair procedure
- •(Microfracturing, MACI, ACT) or degenerative cartilage lesions (Outerbridge >ll
- •and defect >1cm2)
- •* Non-repairable meniscus lesions requiring a resection of >20%
- •* Previous tendon removal on injured leg
- •* Relevant permanent medication (Steroids, cytostatic drugs, ...)
- •* Pregnancy
- •* Reumatoid arthritis
- •* Instability of the contralateral leg
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