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Набор скоро начнётся NCT07394348

Impact of Rotator Cuff Repair on Rehabilitation Outcome

— Наблюдательное Rotator Cuff Repairs

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Jamar Handheld dynanometer.
Кому может быть актуально
Состояния в реестре: Rotator Cuff Repairs. Базовые параметры: 50 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

Impact of Biceps Tenotomy Versus Tenodesis on Rehabilitation Outcomes After Rotator Cuff Repair

Обзор

This study will investigate the difference between BTT (biceps tenotomy ) versus BTD (biceps tenodesis)in patients undergoing rotator cuff repair on postoperative shoulder pain levels, shoulder function, HGS, forearm supination muscle strength, elbow flexion strength

Подробное описание

Rotator cuff tears are common musculoskeletal conditions that are often degenerative and typically affect older adults. They may or may not be symptomatic, and their prevalence increases significantly with age, from approximately 9.7% in individuals under 20 years to 62% in those over 80 years. The rotator cuff plays a critical role in stabilizing the shoulder joint through the concavity-compression mechanism, and its dysfunction can result in shoulder instability, pain, and reduced upper limb strength. Conservative management, including physical therapy, therapeutic modalities, and medications, is considered the first-line approach for treating Rotator cuff tears , while surgical intervention is reserved for cases unresponsive to conservative treatment. Among the commonly performed surgical procedures, biceps tenotomy and biceps tenodesis are often combined with rotator cuff repair to alleviate pain and improve functional outcomes. Hand grip strength is widely recognized as a reliable indicator of overall upper limb function and may be affected by both the pathology and its surgical management. Despite its clinical relevance, limited studies have directly compared the impact of Biceps tenotomy and Biceps tenodesis on Hand grip strength. Furthermore, these surgical techniques may influence other functional outcomes, including elbow flexion strength, forearm supination strength, and pain perception. Therefore, this study seeks to investigate and compare the effects of Biceps tenotomy versus Biceps tenodesis on these parameters in patients undergoing surgical repair for rotator cuff tears.

Вмешательства

  • Устройство Jamar Handheld dynanometer
    is a precision instrument used to measure isometric grip strength. It is widely recognized in clinical research as the "gold standard" for assessing hand strength and general upper-body physical function due to its high test-retest reliability and inter-instrument validity.

Первичные конечные точки

  • Pain level [Срок оценки: 3 time intervals ( pre , within 1 week post , 3 months post )]
  • shoulder function [Срок оценки: 3 time intervals ( pre , within 1 week post , 3 months post )]
Вторичные конечные точки (3)
  • Hand grip strength [Срок оценки: 3 time intervals ( pre , within 1 week post , 3 months post )]
  • Elbow flexion strength [Срок оценки: 3 time intervals ( pre , within 1 week post , 3 months post )]
  • Forearm supination strength [Срок оценки: 3 time intervals ( pre , within 1 week post , 3 months post )]

Критерии участия

Критерии включения

The participant's selection will be based on the following criteria:

  • Both genders adults diagnosed with ≥ 1-cm full-thickness tears of rotator cuff.
  • Age ranged from 50 to 70 years .
  • LHB pathology is involved that will receive ARCR combined with biceps tenotomy or tenodesis.
  • Arthroscopically confirmed LHB pathology.
  • Functionality according to their physical level -

Критерии исключения

Participants will be excluded if they have any of the following criteria:

  • Massive irreparable tears.
  • Inflammatory arthritis.
  • Thyroid disease.
  • Glenohumeral osteoarthritis.
  • Severe cervical disorders or paralysis of the axillary nerve.
  • Previous surgery of the affected shoulder.
  • Revision surgeries for a rotator cuff tear.
  • Complete LHBT rupture. -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Liu YC, Huang SW, Adams CR, Lin CY, Chen YP, Kuo YJ, Chuang TY. Preoperative handgrip strength can predict early postoperative shoulder function in patients undergoing arthroscopic rotator cuff repair. J Orthop Surg Res. 2024 Apr 30;19(1):270. doi: 10.1186/s13018-024-04750-8. PMID 38689328
  • Aouad D, El Rassi G. Shoulder Arthroscopic Rotator Cuff Repair With Biceps Tenodesis and Acromioplasty Using a Single Working Portal. Arthrosc Tech. 2021 Mar 22;10(4):e1125-e1129. doi: 10.1016/j.eats.2021.01.005. eCollection 2021 Apr. PMID 33981560

Идентификаторы

NCT: NCT07394348 · Rehab outcomes in Rotator cuff

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗