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Идёт набор NCT05757739

Randomized Controlled Trial (RCT) of Open Debridement Versus Tenex

Без фазы С лечением Orthopedic Devices Associated With Misadventures

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: Tenex Procedure, Open Debridement Surgical Intervention Treatment Plan.
Кому может быть актуально
Состояния в реестре: Orthopedic Devices Associated With Misadventures. Базовые параметры: 18 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
США
Следующий шаг
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Официальное название

Randomized Controlled Trial (RCT) of Open Debridement Versus Percutaneous Ultrasonic Treatment for Symptomatic Lateral Epicondylitis.

Обзор

Lateral epicondylitis (Tennis Elbow) can cause pain and keep individuals from completing their daily activities and require them to miss work. There are currently different treatment options to address tennis elbow. However surgeons do not know if one is better than the other. This study will compare two treatment options for tennis elbow. Participants will either be treated by Ultrasound-guided Percutaneous Tenotomy Technique or Open Surgical Debridement. Traditional open surgical debridement is a surgical procedure that requires the surgeon to make an incision to remove the damaged tissue. This procedure is done under anesthesia in a surgery center. In the Tenex procedure, the surgeon inserts a special needle into the damaged portion of the tendon under ultrasound guidance. Ultrasonic energy vibrates the damaged tissue and it can be suctioned out. This procedure is done with local anesthesia in surgeon's office.

Подробное описание

During the initial screening visit, the physician will obtain your medical history and perform a physical exam. If you pass the screening, you will be randomized into either Ultrasound-guided Percutaneous Tenotomy Technique or Open Surgical Debridement. It will be a 50% chance. It will be compared to flipping a coin.

Once you have been placed in your treatment group, your treatment will be scheduled. You will have follow up appointments with your physician to monitor your progress at 3 week(visit 3), 6 weeks (visit 4), 3 months (visit 5) 6 month (visit 6), and 12 month (visit 7) time points. You will also be requested to complete patient questionnaires about your progress at visits 3-7.

Вмешательства

  • Процедура Tenex Procedure
    In the Tenex procedure, the surgeon inserts a special needle into the damaged portion of the tendon under ultrasound guidance. Ultrasonic energy vibrates the damaged tissue and it can be suctioned out. This procedure is done with local anesthesia in surgeon's office.
  • Процедура Open Debridement Surgical Intervention Treatment Plan
    Operative treatment will be performed under anesthesia, and debridement of the extensor tendon's common origin will be performed with an open assessment of the tendon origin with tendon repair or reattachment

Первичные конечные точки

  • The objective of this study is to compare, complications, function outcomes, in patients treated with traditional open surgical techniques versus ultrasonic ablation [Срок оценки: Study Enrollment Period]

Критерии участия

Критерии включения

  • Individuals 18-70 years of age
  • Clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities.
  • Failed alternative treatment for > 3 months.

Критерии исключения

  • Surgical procedure on affected extremity within last six months.
  • Dermatological disorder in affected area
  • Currently pregnant, confirmed via pregnancy test.
  • Blood disorders, autoimmune disorders, disorders requiring immunosuppression, cancer, malignancies, an ongoing infectious disease, or sickle cell or other blood disorders.
  • Failed prior surgical procedure on the affected joint.
  • No prior effort to treat (stretching, rest, medication) or implementation of external protocol in an effort to improve condition (physical therapy, massage treatment, rehabilitation techniques).

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
Другое

Центры проведения

США · 10 центров
  • Virtua Reconstructive Orthopedics — Burlington
  • Virtua Reconstructive Orthopedics — Cherry Hill
  • Virtua Reconstructive Orthopedics — Moorestown
  • Fellowship Surgical Center — Mount Laurel
  • Surgical Center of South Jersey — Mount Laurel
  • Virtua Reconstructive Orthopedics — Riverside Park
  • Virtua Reconstructive Orthopedics — Sewell
  • Centennial Surgery Center — Voorhees Township
  • … и ещё 2 центра

Идентификаторы

NCT: NCT05757739 · G23004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗