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临床试验/NCT06870708
NCT06870708已完成不适用

Arthroscopic Repair Of Partial Thickness Articular Side Rotator Cuff Tears Using Transtendon Versus Conversion Repair Techniques

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
American Shoulder and Elbow Surgeons score

研究概览

简要总结

This study aims to compare the functional results of patients who underwent two different arthroscopic methods for the management of articular-sided partial-thickness rotator cuff tears (PT-RCTs).

The present study aims to compare the functional results following the repair of PT-RCTs using the conversion versus the trastendon techniques

详细描述

This is a prospective randomized study carried out at a tertiary trauma center between October 2022 and June 2023. The research ethical Committee authorized this study protocol [(Institutional Review Board (IRB) number: N-383-2023)], and all participants signed an informed consent prior to joining the study. This study included 50 patients with PT-RCTs who underwent arthroscopic repair using either the conversion technique (25 patients) in group A or the transtendon technique (25 patients) in group B. The random assignment of all patients to enter either group was computerized using simple randomization.

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
None

入排标准

年龄范围
49 Years 至 63 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The inclusion criteria were:
  • •Patients suffering symptomatic PT-RCTs exceeding 50% of the tendon thickness, documented by preoperative magnetic resonance imaging (MRI) and confirmed by arthroscopy intraoperative.
  • •Failure of nonoperative management for at least 3 months.

排除标准

  • •Prior shoulder surgery.
  • •Severe concomitant pathologies including glenohumeral arthritis, advanced subscapularis tear, and biceps tendon rupture.
  • •Associated Bankart lesion.
  • •Patients with uncontrolled Diabetes mellites.

研究组 & 干预措施

The Conversion repair technique: Group A

Experimental

arthroscopic repair of partial rotator cuff tear using the conversion technique

干预措施: arthroscopic repair of partial rotator cuff tear using the conversion versus the transtendon technique (Procedure)

The Transtendon repair technique: Group B

Experimental

arthroscopic repair of partial rotator cuff tear using the transtendon technique

干预措施: arthroscopic repair of partial rotator cuff tear using the conversion versus the transtendon technique (Procedure)

结局指标

主要结局

American Shoulder and Elbow Surgeons score

时间窗: baseline, and 18 months after surgery

shoulder score, the maximum is 100, the minimum is zero, a higher score means a better outcome

Constant and Murley score

时间窗: baseline, and 18 months after surgery

shoulder score, the maximum is 100, the minimum is zero, a higher score means a better outcome

次要结局

  • Visual analogue scale(baseline, and 18 months after surgery)

研究者

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

Mohamed hussein khalil

principal investigator

Cairo University

研究点 (1)

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