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临床试验/CTRI/2022/11/047637
CTRI/2022/11/047637已完成不适用

A retrospective, single centre, observational study to evaluate the safety, clinical outcomes and patient reported outcomes after meniscus repair using Surestitch all inside meniscal repair implant.

Healthium Medtech Limited1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
To evaluate the clinical outcomes after meniscus repair using Surestitch all inside meniscal repair implant.

研究概览

简要总结

Thisstudy is a retrospective, single centre, observational study to evaluate thesafety, clinical outcomes and patient reported outcomes after meniscus repairusing Surestitch all inside meniscal repair implant. All patients who hadundergone meniscus repair using Surestitch all inside meniscal repair implantbetween October 2020 to July 2022 will be included in the study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Male or Female patients with age of 18-
  • Patients who underwent meniscus repair with Surestitch meniscus repair implant between October 2020 to July
  • Able to give written informed consent during hospital visit or provide a verbal consent during a telephonic visit.

排除标准

  • Patient who has suffered from traumatic injury to the operated knee after the meniscus repair surgery
  • Patient who cannot be contacted for attending an inclinic/telephonic follow-up visit.

结局指标

主要结局

To evaluate the clinical outcomes after meniscus repair using Surestitch all inside meniscal repair implant.

时间窗: At baseline

次要结局

  • 1. To evaluate the patient reported outcomes after meniscus repair using Surestitch all inside meniscal repair implant(2. To evaluate the safety of the SURESTITCHâ„¢ meniscal repair implant after meniscus repair surgery.)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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