跳至主要内容
临床试验/NCT02296554
NCT02296554终止不适用

SLAP Repair Versus Biceps Tenodesis for SLAP Tears in the Shoulder: A Randomized Outcomes Study

HealthPartners Institute2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
150
试验地点
2
主要终点
Patient reported function and pain

研究概览

简要总结

Biceps Tenodesis is currently advocated for older, less active patients, but to date is not often advocated for Superior Labral Tear from Anterior to Posterior (SLAP) tears in young, active patients. The ideal surgical management for this pathology is not clearly known. More surgeons are using biceps tenodesis as a treatment for SLAP tears, including in the young, active population. If this study were to demonstrate that biceps tenodesis is similar to or better than SLAP repair, this would fundamentally change the treatment of SLAP tears. Perhaps more importantly, it would likely mean a less involved rehabilitation and earlier return to activities for patients with this pathology.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Primary isolated SLAP tear, confirmed on MRI

排除标准

  • Concomitant procedure needed such as a labral repair, rotator cuff repair or distal clavicle excision.
  • Revision Surgery
  • Previous shoulder surgery
  • Major medical illness
  • Inability to speak or read English

研究组 & 干预措施

Biceps Tenodesis Repair

Experimental

Patient will receive biceps tenodesis repair for their SLAP tear.

干预措施: Biceps Tenodesis (Procedure)

SLAP Repair

Experimental

Patient will receive SLAP repair for their SLAP tear.

干预措施: SLAP Repair (Procedure)

结局指标

主要结局

Patient reported function and pain

时间窗: 5 years

ASES

次要结局

  • Range of Motion(3 months)
  • Range of Motion & Strength(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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