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临床试验/NCT05146791
NCT05146791已完成不适用

Clinical and Radiographic Outcomes in Arthroscopic Cuistow Procedure and Arthroscopic Modified Bristow Procedure

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年1月17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
70
试验地点
1
主要终点
Bone union rate

研究概览

简要总结

To evaluate the clinical and radiographic outcomes of arthroscopic Chinese Unique Inlay Bristow procedure (Cuistow procedure) and arthroscopic Bristow procedure in treating recurrent anterior shoulder instability.

详细描述

Aim: To compare the clinical and radiographic outcomes following the arthroscopic Chinese Unique Inlay Bristow (Cuistow) procedure and the arthroscopic Bristow procedure.

Background: The Cuistow procedure is a modified Bristow surgery in which a Mortise and Tenon structure was added to the contact surface between the coracoid tip and the glenoid. In previous study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no comparative studies was performed.

Study Design: Retrospective comparative case-cohort study

Methods: Patients who underwent the arthroscopic Cuisotw procedure and modified Bristow procedure between Jan 2017 and Mar 2018 were selected. 70 patients with recurrent anterior shoulder instability were included. Radiological evaluations with 3D CT scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). Clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, University of California at Los Angeles scoring system (UCLA score), American Shoulder and Elbow Surgeons score (ASES score), ROWE score, Subjective Shoulder Value (SSV) and active range of motion were completed by independent observers and analyzed.

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% but <25%,
  • participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect <25% of the glenoid or without defect
  • failure after Bankart repair.

排除标准

  • multidirectional shoulder instability (MDI),
  • uncontrolled epilepsy
  • pathological involvement of other soft tissue such as the long head of the biceps or a rotator cuff tear
  • previous shoulder stability surgery other than Bankart repair
  • Follow-up was less than 2 years or incomplete follow-up data.

结局指标

主要结局

Bone union rate

时间窗: 2-year postoperatily

Bone healing was observed in 3D-CT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people.

ASES score

时间窗: 2-year postoperatively

The ASES score (Michener 2002) is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.

次要结局

  • VAS for pain score(2-year postoperatively)
  • dislocation rate(2-year postoperatively)
  • Active shoulder ranges of motion(2-year postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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