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临床试验/NCT07289334
NCT07289334
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Tenotomy Versus no Tenotomy of the Long Head of the Biceps in Rotator Cuff Repair: Clinical-functional Analysis and Ultrasound Evaluation

Consorci Sanitari de Terrassa0 个研究点目标入组 60 人开始时间: 2015年1月1日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Consorci Sanitari de Terrassa
入组人数
60
主要终点
Constant Murley

概览

简要总结

The function of the long head of the biceps tendon (LHBT) in the glenohumeral joint generates controversy among researchers. For some, the tendon does not have a significant function in the shoulder, while others consider it acts as a depressor of the humeral head and a stabilizer of the joint. These functions may be enhanced in cases of rotator cuff injuries, where compensatory hypertrophy and/or instability of the LHBT can occur, which can also be a source of pain. One of the imaging techniques used for diagnosing these injuries is ultrasound.

Initially, G. Walch proposed tenotomy of the LHBT in massive rotator cuff tears to improve pain and, in some cases, shoulder function. Currently, many authors advocate tenotomy of the LHBT as an adjunct to rotator cuff repair to avoid postoperative pain. However, there is no evidence that this procedure improves the clinical outcomes of isolated rotator cuff repair.

Based on the pathophysiology of the LHBT associated with rotator cuff injuries and the current trend to perform tenotomies in conjunction with cuff repair, the objectives of this doctoral thesis project were:

To compare the clinical and imaging outcomes of arthroscopic rotator cuff repairs with and without LHBT tenotomy.

To analyze the position and cross-sectional area of the LHBT in the bicipital groove using ultrasound in cases with and without tenotomy.

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
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 40 and 65 years
  • Partial supraspinatus tears (≥ 50% thickness)
  • Complete supraspinatus tears ≤ 3 cm in the coronal plane
  • Muscle atrophy less than stage 2 according to Thomazeau
  • Presence of the LHBT in the bicipital groove

排除标准

  • Patients younger than 40 or older than 65 years
  • LHBT rupture
  • Partial supraspinatus tears \< 50% thickness
  • Supraspinatus tears \> 3 cm
  • Tears of other rotator cuff tendons, with or without supraspinatus involvement
  • Traumatic tears with surgery performed less than 3 months after injury
  • Muscle atrophy ≥ stage 2 Thomazeau
  • Associated degenerative glenohumeral pathology (\> Samilson 1)
  • Previous shoulder surgeries
  • Previous shoulder infections

结局指标

主要结局

Constant Murley

时间窗: 24 month

100-point standardized tool for assessing shoulder function, comprising four domains Pain (0-15 points) daily life activity (0-20 points) range of motion (0-40 points) strenght (0-25 points) 0 (the worst) - 100 (the best)

次要结局

  • cross sectional area of the LHBT(24 months)
  • ASES(24 MONTHS)

研究者

发起方
Consorci Sanitari de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Maria Mora Guix

Surgeon of Shoulder Unit, Consorci Sanitari de Terrassa

Consorci Sanitari de Terrassa

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