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临床试验/NCT03352180
NCT03352180Unknown不适用

Do Concomitant Subscapularis Tears in Large to Massive Rotator Cuff Tears

Wonkwang University Hospital2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2017年11月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Visual analogue scale

研究概览

简要总结

Do concomitant subscapularis tears in large to massive rotator cuff tears affect postoperative functional and structural outcomes?

Background and purpose:

The subscarpularis tendon is essential force maintaining normal glenohumeral biomechanics. However, there are few studies which have addressed the outcomes of tears extending to the subscapularis tendon in massive rotator cuff tears. The purpose of this study was to assess the clinical and structural outcomes of arthroscopic reapair of massive rotator cuff tears involving the subscapulrais.

详细描述

MATRALS AND METHODS This retrospective comparative study was approved by our institutional review board.

Patient Selection This study targeted patients who had undergone arthroscopic rotator cuff repair, which was performed by a single surgeon in our institution between January 2010 and January 2014.

The inclusion criteria were as follows: (1) a full-thickness superoposterior rotator cuff tear larger than 5 cm(19) or complete superoposterior rotator cuff tear(24) identified on preoperative MRI and intra operative arthroscopic findings, (2) a follow-up MRI evaluation at 6 months after surgery, and (3) a clinical assessment performed a minimum 2 years postoperatively. The exclusion criteria were as follows: (1) small, medium, or large tears(21); (2) a partial-thickness tear; (3) an isolated subscapularis tear; (4) failure of subscapularis repair at the time of the index procedure; (5) previous rotator cuff surgery of the affected shoulder; (6) concomitant surgery for glenohumeral joint instability or other bony procedure; and (7) substantial glenohumeral arthritis (Hamada classification29 grade 4) or inflammatory arthropathy of the affected shoulder.

Tear Classification Rotator cuff tear patterns were classified into the following 3 categories according to the tear size of the subscapularis tendon on preoperative MRI: I-massive tear, intact subscapularis tendon; S-massive tear, tear involving half or less than half of the subscapularis tendon; and L-massive tear, tear extending to more than half of the subscapularis tendon.

Clinical Assessments Clinical data were recorded on the day before surgery and at final follow-up (at least 24 months postoperatively) by fellowship trainees. Four outcome measures were used in this study: VAS pain score, ASES score, Constant score, and active shoulder ROM. The ASES score involves a score summation using a 100-point system (50 points for daily function and 50 points for pain).

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
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • a full-thickness superoposterior rotator cuff tear larger than 5 cm or complete superoposterior rotator cuff tear identified on preoperative MRI and intra operative arthroscopic findings
  • a follow-up MRI evaluation at 6 months after surgery, and
  • a clinical assessment performed a minimum 2 years postoperatively.

排除标准

  • small, medium, or large tears
  • a partial-thickness tear
  • an isolated subscapularis tear
  • failure of subscapularis repair at the time of the index procedure
  • previous rotator cuff surgery of the affected shoulder
  • concomitant surgery for glenohumeral joint instability or other bony procedure
  • substantial glenohumeral arthritis (Hamada classification grade 4) or inflammatory arthropathy of the affected shoulder.

结局指标

主要结局

Visual analogue scale

时间窗: 4weeks

The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

次要结局

  • The American Shoulder and Elbow Surgeons Shoulder Score (ASES)(4weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Woo Kim

Department of Orthopedic Surgery, Wonkwang University Hospital, Iksan, Korea Professor Jeong Woo Kim, MD

Wonkwang University Hospital

研究点 (2)

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