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Идёт набор NCT05660031

Treatment of the Biceps With Concomitant Supraspinatus Tears

Без фазы С лечением Supraspinatus Tear

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: LHB Tenotomy, LHB Tenodesis.
Кому может быть актуально
Состояния в реестре: Supraspinatus Tear. Базовые параметры: 50 лет — 80 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
США, Канада, Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial

Обзор

The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.

Подробное описание

The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology.Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The secondary goals are to determine whether there is a difference in post-operative functional outcomes between the LHB tenotomy group and the Intact LHB group, and if there is a difference in complication rates or patient satisfaction between the three groups.

Вмешательства

  • Процедура LHB Tenotomy
    Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors
  • Процедура LHB Tenodesis
    "ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.

Первичные конечные точки

  • ASES score [Срок оценки: At 24 post-operative months]
Вторичные конечные точки (12)
  • VAS pain [Срок оценки: At 24 post-operative months]
  • SSV [Срок оценки: At 24 post-operative months]
  • LHB score [Срок оценки: At 24 post-operative months]
  • AFF [Срок оценки: At 24 post-operative months]
  • ER at side [Срок оценки: At 24 post-operative months]
  • IR [Срок оценки: At 24 post-operative months]
  • Complications [Срок оценки: Within 2 postoperative years]
  • Patient satisfaction [Срок оценки: At 24 post-operative months]
  • Location of the defect (at the foot print | medial cuff failure) [Срок оценки: At 6 post-operative month]
  • Status of the biceps tendon (intact | in continuity | defect) [Срок оценки: At 6 post-operative month]
  • Signs of anchor displacement and location (lateral | medial row). [Срок оценки: At 6 post-operative month]
  • Tendon thickness [Срок оценки: At 6 post-operative month]

Критерии участия

Критерии включения

  • Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
  • Full thickness tear of the supraspinatus tendon
  • Intact subscapularis tendon
  • Primary rotator cuff repair
  • Age 50-80

Критерии исключения

  • Previous full thickness biceps tear
  • Infection and neuropathic joints
  • Known or suspected non-compliance, drug or alcohol abuse
  • Patients incapable of judgement or under tutelage
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Patient declines to participate in study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Sports Medicine and Shoulder Surgery, University of Michigan — Ann Arbor
  • Oregon Health & Science University — Portland
Канада · 1 центр
  • Group 23 Sports Medicine — Calgary
Швейцария · 1 центр
  • la Tour hospital — Meyrin

Идентификаторы

NCT: NCT05660031 · 2021-00066

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗