Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch)

Официальное название

Study Evaluating the Clinical Improvement Obtained by Endoscopic Tenotomy of the Ilio-Psoas, at the Level of the Lesser Trochanter Versus at the Level of the Acetabular Notch, on Psoas Cup Impingements After Total Hip Prosthesis

Обзор

The purpose of the study is to assess Oxford Hip Score at baseline, at 2 months and at over 12 months.

Подробное описание

This is an interventional, comparative, randomized study, in 2 parallel groups, single-blind (the patient does not know which technique he will benefit from, the surgeon will carry out the surgery and will therefore be informed of the result of the randomization ) and monocentric.

Comparative prospective cohort study of an endoscopic tenotomy surgery of the iliopsoas tendon at the level of the lesser trochanter versus at the level of the acetabular notch, in the context of anterior pain for impingement between the iliopsoas tendon and the prosthetic cup in patients after Total Hip Prosthesis.

The study will be proposed to the patient during the preoperative consultation. Patients eligible for surgery will be offered the study. After a reflection period of at least 15 days, patients who agree to participate in the study will be included. Randomization will be done by drawing lots to decide whether the endoscopic tenotomy will be performed at the level of the lesser trochanter or at the level of the acetabular notch. The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.

Вмешательства

• Процедура Endoscopic tenotomy surgery of the iliopsoas tendon
  The surgery will be performed under general anesthesia with standardized multimodal analgesia. Whatever the techniques, the approaches, the instruments to perform the procedure and the postoperative course will be identical, as in usual practice.

Первичные конечные точки

• Oxford Hip Score [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age ≥ 18 years old;
• Definite diagnosis of iliopsoas tendinopathy due to conflict between the tendon and the prosthetic cup;
• Failure of first-line conservative treatment;
• Planned endoscopic tenotomy;
• Affiliation to the social security scheme;
• Signed informed consent.

Критерии исключения

• Revision total hip prosthesis, multiple operations prior to tenotomy;
• Other surgical or medical interventions planned during the study;
• Participation in another clinical trial, or during a period of exclusion from another clinical trial;
• Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
• Patient deprived of liberty or under guardianship or curatorship or unable to give consent.

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

Франция · 1 центр

• Clinique de la Sauvegarde — Lyon

Идентификаторы

NCT: NCT05950022 · 2023-A00802-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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