跳至主要内容
临床试验/NCT04460118
NCT04460118已完成不适用

Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
1
主要终点
VAS for pain score

研究概览

简要总结

Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

详细描述

Background:Some studies have advocated the use of suture-button fixation during Bristow-latarjet surgery to reduce complications associated with screw fixation. However, these studies are not comparative studies, and their data are relatively incomplete.

Purpose: To compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were selected. Shoulders were separated into two groups based on surgical fixation method. Radiological results on 3D CT scan and clinical results were assessed preoperatively, immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the final follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • a glenoid defect ≥10%
  • contact sport athletes with a glenoid defect < 10%
  • failure after Bankart repair.

排除标准

  • multidirectional shoulder instability
  • concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
  • Follow-up was less than 2 years or incomplete follow-up data.

结局指标

主要结局

VAS for pain score

时间窗: 2 years after surgery

The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.

ASES score

时间窗: 2 years after surgery

The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.

次要结局

  • Active shoulder ranges of motion(2 years after surgery)
  • Bone union(3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery)
  • Bone block position(immediately after surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验