Arthroscopic Rotator Cuff Repair Trial

Официальное название

A Prospective Randomized Controlled Trial Comparing Arthroscopic Rotator Cuff Repair With and Without Biceps Tendon Autograft Patch Augmentation

Обзор

This study aims to assess post-operative outcomes and healing rates following arthroscopic rotator cuff repair with and without biceps tendon autograft patch augmentation in patients with medium to large rotator cuff tears. This will be a single center, parallel arm randomized trial within the Orthopedics Shoulder Surgery Department at University of Iowa Hospitals and Clinics (UIHC). Eligible patients indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis will be enrolled, consented and randomized, in a 1:1 scheme, into 2 study arms. Arm 1 will consist of arthroscopic rotator cuff repair without biceps tendon autograft. Arm 2 will consist of arthroscopic rotator cuff repair with biceps tendon autograft patch augmentation. Outcomes of interest are American Shoulder and Elbow Surgeons Score (ASES), at 1 year and 2 years postoperatively. Exploratory outcomes are SANE, VAS Pain and active shoulder range of motion, and healing signs on MRI imaging studies at minimum 6-months postoperatively.

Подробное описание

Rotator cuff tears are common causes of shoulder pain, and it is a highly prevalent condition among a variety of ages. Treatment options for rotator cuff tears include nonsurgical and surgical options. Surgical repair of rotator cuff tears is a widely accepted treatment option; however, re-tear rates are concerning and a frequent complication. Published studies suggest failure rates ranging from 11-94%. Different surgical techniques have been designed to address this potential complication, such as patch augmentation. Recently, patch augmentation with biceps tendon autograft has been utilized as a cost-effective approach. Therefore, the purpose of this study is to evaluate and compare post-operative outcomes and tendon healing rates after rotator cuff repairs with and without patch augmentation with biceps tendon. This study aims to assess post-operative outcomes and healing rates following arthroscopic rotator cuff repair with and without biceps tendon autograft patch augmentation in patients with medium to large rotator cuff tears. Both surgical techniques are standard of care procedures performed routinely at University of Iowa Health Care. This will be a single center, parallel arm randomized trial within the Orthopedics Shoulder Surgery Department at University of Iowa Hospitals and Clinics (UIHC). Eligible patients indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis will be enrolled, consented and randomized, in a 1:1 scheme, into 2 study arms. Arm 1 will consist of arthroscopic rotator cuff repair without biceps tendon autograft. Arm 2 will consist of arthroscopic rotator cuff repair with biceps tendon autograft. Outcomes of interest are American Shoulder and Elbow Surgeons Score (ASES), at 1 year and 2 years postoperatively. Exploratory outcomes are SANE, VAS Pain and active range of motion, and healing signs on imaging studies at minimum 6-months postoperatively. Participants in both arms will undergo a shoulder MRI without contrast at 6 months post-operatively. This MRI is the same type of MRI perform as diagnosis or control as standard of care practices.

Вмешательства

• Процедура Rotator cuff repair with biceps patch augmentation
  This is a standard of care practice surgical technique. This arm will undergo arthroscopic rotator cuff repair with the use of called "Biceps Smash" technique which may provide improved tendon thickness and biology with limited morbidity and in a cost effective approach
• Процедура Rotator cuff repair without biceps patch augmentation
  Standard of care technique. Active comparator

Первичные конечные точки

• ASES Score [Срок оценки: 1 year post-operative]

Вторичные конечные точки (1)

• Rotator cuff healing [Срок оценки: 6 months post-operative]

Критерии участия

Критерии включения

• Patients > 18 years of age who speak English, indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis.
• Supraspinatus (+/- anterior infraspinatus tendon) full thickness tears.
• Medium (1-3cm) and large (3-5) cm tears. Classification according to anterior to posterior dimensions: small <1cm, medium 1-3 cm, large 3-5 cm, massive >5cm or 2 tendons.
• Patte Grade 1 and 2. Patte Classification: grade 1, tear at insertion; grade 2, retracted to humeral head; grade 3, retracted to glenoid or medial to glenoid.
• Goutallier grade 0-2 fatty infiltration on pre-operative MRI.
• Repairable upper border subscapularis tendon tear.
• Patients undergoing concomitant biceps tenodesis.

Критерии исключения

• Pregnant women, non-English speakers and prisoners.
• Patients with prior surgery on the ipsilateral shoulder.
• Worker's compensation status.
• Adhesive capsulitis.
• Patient with glenohumeral osteoarthritis, as graded by the modified Samilson and Prieto Classification (grades 1-3).
• Partial thickness rotator cuff tears.
• Any cuff tears requiring medialization of the footprint
• Patients undergoing concomitant distal clavicle resection.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07568392 · 202512509

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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