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临床试验/NCT03654118
NCT03654118已完成不适用

Long-term Review of a Cohort of Arthroscopic Bankart Interventions

Rennes University Hospital11 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2017年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
125
试验地点
11
主要终点
Number of instability recurrence after arthroscopic Bankart intervention

研究概览

简要总结

Recurrent instability is the most common chronic shoulder pathology of the young and athletic patient. It is a source of functional, sporting and professional disability, and a permanent apprehension to the use of the affected shoulder.

Surgical treatment has been proposed for a long time by the reintegration of the labrum (intervention of Bankart) then by the making of an osteo-muscular stop (intervention of Latarjet).

Like in many domains, surgical techniques have evaluated towards the search for endoscopic alternatives to open surgery, more deleterious.

Bankart's intervention has been performed arthroscopically since the 1980s and remains the majority intervention in the United States. However, its success rate never reached that of open techniques, Bankart and Latarjet. Surgeons therefore sought the predictors of these failures in order to define the limits of the indications for arthroscopic Bankart intervention.

The determination and use of the preoperative instability score (Instability Severity Index Score : ISIS) described by Balg and Boileau is one of the ways to clarify these indications.

The aim of this study is to prospectively establish the values of the ISIS score to obtain an acceptable recurrence rate of long-term instability

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

  • Major patient
  • Patient who already volunteered in a first ISIS study
  • Inclusion Criteria of the ISIS Study:
  • Patients operated between December 2007 and December 2008 for recurrent shoulder instability, according to the arthroscopic procedure (Arthroscopic Bankart) in the investigative centers and presenting at the time of the indication of operation an ISIS score of ≤ 4 points (regardless of the positive criteria) (see Annex 2- ISIS score)
  • Age> 16 years
  • Supported by a joint arthroscopic technique completed.
  • Patient not objecting to his participation in the study
  • Exclusion Criteria (same as those of the ISIS study)
  • First dislocation or resumption of another technique at the time of indication for surgery
  • Voluntary or multidirectional instability at the time of the indication of operation
  • Painful shoulder without instability felt at the time of the operative indication
  • Lesion of the cap (perioperative report)
  • Humeral lesions Avulsion Gleno-humeral Ligament (per-operative finding)
  • Unsuccessful technique
  • Major benefiting from a legal protection measure (safeguard of justice, trusteeship, guardianship)

排除标准

  • 未提供

结局指标

主要结局

Number of instability recurrence after arthroscopic Bankart intervention

时间窗: Through study completion, 2 months on average

The rate of instability recurrence 9 years after an arthroscopic Bankart intervention, is derived from the patient's responses to the interview

次要结局

  • Predictive value of the ISIS score in the occurrence of recurrence of instability(Through study completion, 2 months on average)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (11)

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