Идёт набор NCT03718637

Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Фаза IV С лечением Tennis Elbow Lateral Epicondylitis

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: Smith & Nephew Bioinductive Implant, Lateral Epicondylectomy, Ultrasound Imaging.
Кому может быть актуально: Состояния в реестре: Tennis Elbow, Lateral Epicondylitis. Базовые параметры: от 18 лет · Мужчины.
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
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Обзор

The investigators are testing the efficacy of a new, FDA-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients. A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomize into one of two groups: control and investigational. Patients in the "control group" will receive the normal surgery for patients who do not respond to physical therapy, lifestyle changes, and anti-inflammatory treatment. Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

Подробное описание

A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non surgery options for 6 months (physical therapy, lifestyle changes, anti-inflammatories, injections) Patients in the "control group" will receive the standard surgery (open lateral epicondylectomy) . Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

Вмешательства

Биопрепарат Smith & Nephew Bioinductive Implant
A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.
Процедура Lateral Epicondylectomy
This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.
Лучевая терапия Ultrasound Imaging
An ultrasound will be performed on each patient both preoperatively and at 6 months.

Первичные конечные точки

PROMIS CAT Scores [Срок оценки: Preoperative to 1 year postoperative]
Visual Analog Scale (VAS) for Pain [Срок оценки: Preoperative to 1 year postoperative]
Range of Motion [Срок оценки: Preoperative to 1 year]

Критерии участия

Критерии включения

Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.