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临床试验/NCT04468906
NCT04468906终止不适用

Tenodesis vs. Self-locking Tenotomy in Long Head of the Biceps Tendon Lesions: A Randomized Clinical Trial

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
42
试验地点
2
主要终点
Rate of Reverse Popeye Deformity

研究概览

简要总结

One of the common complaints after long head of the biceps brachii tendon (LHBT) surgery is a Popeye deformity, which can occur with both the tenodesis and tenotomy. Tenotomy using the traditional technique has a higher incidence of Popeye deformity as the residual stump is not fixated in place. However, the more recently-described self-locking tenotomy improves upon this by having a wider stump base to theoretically prevent reduce the incidence of tendon retraction down the bicipital groove. If this technique is shown to result in a similar incidence of Popeye deformity, then it may be preferable to tenodesis due to its advantages of reduced postoperative pain, more rapid return to activity, and reduced surgical time and cost. The purpose of the proposed study is to evaluate the effect of biceps tenodesis versus self-locking T tenotomy in the management of lesions involving the LHBT.

详细描述

Long head of the biceps brachii tendon (LHBT) lesions are a common pathology and can be a significant source of pain in the shoulder due to the large number of free nerve endings around the tendon. There are 3 main subtypes of LHBT lesions 1) LHBT degeneration, 2) LHBT anchor disorders, and 3) LHBT instability. These lesions can occur both in isolation or in conjunction with rotator cuff disease. Treatment options include tenotomy and tenodesis, and while both are utilized there exists a lack of consensus treatment choice.

The optimal management of LHBT lesions remains controversial, with surgeons typically treating younger patients with tenodesis and older patients with tenotomy. Previous RCTs have failed to discern a clinical difference between tenodesis and tenotomy, apart from the reduced incidence of Popeye deformity in the tenodesis cohorts. However, all previous literature has utilized the traditional biceps tenotomy technique of transecting the tendon just lateral to its insertion on the superior labrum. This results in a narrow tendon stump that usually slips through the transverse humeral ligament and retracts down the arm, resulting in the aforementioned deformity. A newer tenotomy technique, termed the self-locking tenotomy, consists of preserving the attachment of the LHBT on the superior labrum and instead releasing the superior labrum off the glenoid from the 11 o'clock to 1 o'clock positions. As a result, the residual LHBT stump is broad and "T-shaped", which has a lower incidence of retracting down the arm. Using this technique, LHBT tenotomy has been shown to result in similar rates of Popeye deformity as the tenodesis in a number of recent case series.

This will be a single-center randomized controlled trial. The study is comparing biceps tenodesis and self-locking tenotomy in patients undergoing arthroscopic shoulder surgery for lesions involving the LHBT.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary indication is for pathology of the LHBT or biceps-labrum complex
  • Age 40-80
  • Ability to comply with a standardized postoperative protocol
  • Willing and able to provide consent

排除标准

  • Associated rotator cuff tear requiring arthroscopic repair
  • Pregnant patient
  • Age <40 years
  • Previous shoulder surgery
  • Unable to speak English or perform informed consent

结局指标

主要结局

Rate of Reverse Popeye Deformity

时间窗: up to 24 months post-op

Reverse popeye deformity is the loss of the theoretical LHBT stabilizing effect on the humeral head, which can be determined with a physical exam.

次要结局

  • Average timing of return to work/sport(up to 24 months post-op)
  • Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale(6 months post-op, 24 months post-op)
  • Change in Score on Visual Analogue Scale (VAS)(6 months post-op, 24 months post-op)
  • Incidence of fatigue, cramping, biceps groove tenderness(up to 24 months post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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