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临床试验/NCT07014813
NCT07014813已完成不适用

Mini Open Subpectoral Press Fit Biceps Tenodesis

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
The proportion of patients reported having at least a 50% Increase in their Amircan Shoulder and Elbow Society (ASES) Scoring, and decrease in their pain (measured according to VAS score) with no loss in the range of motion.

研究概览

简要总结

Surgical management of long head of biceps (LHB) lesions is frequent, often alongside other shoulder issues. When conservative treatment fails, tenotomy (for low-demand patients) or tenodesis (preferred for active individuals) is performed. Subpectoral tenodesis offers advantages, and this study assesses a novel press-fit bony plug technique for this approach, evaluating its safety and efficacy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Biceps tendon pathologies after failure of conservative measures: biceps tenosynovitis, recurrent subluxation, or SLAP lesions.
  • Young and middle-aged individuals (20-60 years old).

排除标准

  • Patients with avascular necrosis or arthritis.
  • Extensive bone loss.
  • Poor bone density.
  • Active infection.

结局指标

主要结局

The proportion of patients reported having at least a 50% Increase in their Amircan Shoulder and Elbow Society (ASES) Scoring, and decrease in their pain (measured according to VAS score) with no loss in the range of motion.

时间窗: 42 Months

The Success rate of sub-pectoral fixation of the biceps tendon was assessed as that there was proportion of patients who achieved a clinically significant improvement in shoulder and elbow function (at least a 50% increase in ASES score), a notable reduction in pain (decrease in VAS score), while maintaining their ange of motion.

次要结局

未报告次要终点

研究者

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

Hesham Abd ElGhafour Abd ElRady

Assistant Lecturer at Department of Trauma and orthopedics, Faculty of Medicine

Cairo University

研究点 (2)

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