Psoas Tenotomy Under Ultrasound

Обзор

The ilio-psoas conflict is a commonly accepted complication after total hip replacement, often linked to a mispositioning of the acetabular prosthetic component that conflicts with the ilio-psoas tendon. To correct these pains, a psoas tenotomy can be proposed. The results proven by the literature are very satisfactory. Psoas tenotomy is performed endoscopically, arthroscopically, or more rarely open. The contribution of echo surgery allows to limit the scar ransom but also to free itself from a complex infrastructure to the operating room including an arthroscopy column and an intraoperative fluoroscopy for a conventional tenotomy, This also saves procedural and installation time. No studies to date have described ultrasound-assisted psoas tenotomy Yhe investigators conducted a cadaveric study of the feasibility of psoas tenotomy under ultrasound that confirms the feasibility of this technique and the safety of the gesture for the surrounding anatomical structures. The objectives of this study are to assess the feasibility, pain and functional outcomes of ultrasound-assisted psoas tenotomy in patients with ilio-psoas conflict after total hip replacement.

Вмешательства

• Процедура Psoas tenotomy under ultrasound
  Tenotomy of the ilio-psoas tendon under ultrasound is performed using an ultrasound machine, a 3 mm Acufex hook blade and a specific kit usually used for guided vertebroplasty and which allows the introduction of the Acufex hook blade atraumatically (foam end). The patient, under general anesthesia, is placed in supine position with the hip extending from 15 to 20°.

Первичные конечные точки

• Evaluate the success rate of this new ultrasound-guided ilio-psoas tendon tenotomy technique [Срок оценки: 3 weeks post-operative]

Вторичные конечные точки (12)

• Evaluate the new ultrasound-guided ilio-psoas tendon tenotomy technique compared to standard practice on pain experienced by the patient [Срок оценки: Pre-operative, 3 hours, 1 day, 3 weeks, 6 weeks, 3 and 6 months post-operative]
• Evaluate the Oxford Hip Score [Срок оценки: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative]
• Evaluate the Harris Hip Score [Срок оценки: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative]
• Evaluation the Postel and Merle Aubigne score [Срок оценки: At baseline, 3 weeks, 6 weeks, 3 and 6 months post-operative]
• Evaluate the technical difficulty of surgical procedure [Срок оценки: the day after surgery]
• Evaluate the operative time [Срок оценки: the day of surgery]
• Evaluate the installation time [Срок оценки: the day of surgery]
• Evaluate the total blood loss [Срок оценки: in the month before surgery and the day after surgery]
• Evaluate the length of hospital stay [Срок оценки: the day after surgery]
• Evaluate the scarring after surgery [Срок оценки: 6 weeks post-operative]
• Evaluate the impact of the patient's quality of life [Срок оценки: At baseline, 6 weeks, 3 and 6 months post-operative]
• Evaluate the patient satisfaction with the results of the operation [Срок оценки: 3 weeks, 6 weeks, 3 and 6 months post-operative]

Критерии участия

Критерии включения

• Patients 18 years of age or older
• Indication of psoas tenotomy for ilio-psoas conflict after total hip replacement
• Signature of the written informed consent form by the patient
• Affiliation to a French health insurance scheme or equivalent

Non Inclusion criteria:

• Vulnerable people: pregnant or breast-feeding women (patients will undergo a pregnancy test: urinary test), adult under guardianship or deprived of freedom.
• Allergies to local anesthetics
• Patient on anticoagulant or antiplatelet agents
• Contraindication to surgery
• Refusal of patient involvement

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Nice University Hospital — Nice

Идентификаторы

NCT: NCT06064136 · 22-AOIP-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗