跳至主要内容
临床试验/NCT01324531
NCT01324531Unknown2 期

Arthroscopic Bankart Repair With and Without Arthroscopic Infraspinatus Remplissage in Anterior Shoulder Instability With a Hill-Sachs Defect: A Randomized Controlled Trial

Panam Clinic3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
150
试验地点
3
主要终点
Western Ontario Shoulder Instability (WOSI) score

研究概览

简要总结

The purpose of this prospective, randomized, controlled trial is to compare subjective patient-reported outcomes and objective clinical results between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder instability with a Hill-Sachs Defect.

详细描述

Significant osseous defects of the glenohumeral joint can often lead to failure of arthroscopic shoulder stabilization procedures. The best treatment in the setting of shoulder instability with significant glenoid and/or humeral defects remains controversial. Several open procedures have been suggested, but arthroscopic methods have started to garner some attention in the literature. In patients with an engaging Hill-Sachs lesion without significant glenoid bone loss, arthroscopic remplissage consisting of arthroscopic posterior capsulodesis and infraspinatus tenodesis to fill the Hill-Sachs lesion has been proposed as a novel treatment method.

The authors believe it is scientifically necessary to investigate the role of addition of arthroscopic infraspinatus remplissage to the conventional arthroscopic Bankart repair. As more surgeons are trained in the technique, it will be performed more frequently. Increased patient awareness continues to lead to increasing demand for minimally invasive approaches. Arthroscopic remplissage brings with it an increase in operative time, with a theorized risk of reduction in dislocation risk. For these reasons, the authors believe that it is scientifically and fiscally necessary to determine the difference in outcome between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage for patients with anterior shoulder instability and a Hill-Sachs defect in the framework of a prospective, randomized controlled study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • 14 years or older
  • must have anterior shoulder instability and Hill-Sachs defect
  • must have anterior instability with any engaging Hill Sachs Lesion on CT scan, MRI or ultrasound and no more than 15% glenoid bone loss

排除标准

  • Glenoid defect >15% of AP diameter of glenoid
  • significant shoulder comorbidities (i.e, OA, previous surgery other than previous instability)
  • active joint or systemic infection
  • significant muscle paralysis
  • rotator cuff or Charcot's arthropathy
  • significant medical comorbidity that may alter effectiveness of surgical intervention
  • major medical illness
  • unable to speak French or English
  • psychiatric illness that precludes informed consent
  • unwilling to be followed for 2 years

结局指标

主要结局

Western Ontario Shoulder Instability (WOSI) score

时间窗: 24 months post-surgery

WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate

次要结局

  • Ultrasound imaging(24 months post-surgery)
  • Simple Shoulder Test(24 months post-surgery)
  • American Shoulder and Elbow Society assessment (ASES)(24 months post-surgery)

研究者

发起方
Panam Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter MacDonald

Department Head, Orthopaedic Surgery

Panam Clinic

研究点 (3)

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