Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?

Официальное название

Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? A Multicenter Prospective Randomized Controlled Trial

Обзор

The goal of this clinical trial is to analyze the impact of perineal post-free traction versus traditional perineal post traction on perineal complications in hip arthroscopy. The main question it aims to answer is: • Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications? Researchers will compare the perineal-post-free traction group with the conventional perineal-post traction group to see if the former decreases perineal complications and improves efficiency without compromising surgical outcomes. Participants will: * Undergo either perineal-post-free or standard perineal-post traction during hip arthroscopy * Complete nerve-injury checks on day 1 and at discharge, and hip-function questionnaires (VAS, mHHS, IHOT-12, HOS) at 3 months * Allow collection of operating times, hospital stay, and direct medical costs for economic analysis

Вмешательства

• Процедура Perineal Post-Free Traction
  Traction achieved with a thoraco-abdominal belt and contralateral groin strap; operating table tilted 10-15° Trendelenburg under fluoroscopy to 8-10 mm joint space. No perineal post is used, eliminating direct perineal pressure.
• Процедура Perineal Post Traction
  Standard traction table with padded perineal post placed against the groin providing counter-traction; affected limb distracted under fluoroscopy to 8-10 mm joint space while contralateral limb is abducted.

Первичные конечные точки

• The incidence of perineal nerve injury [Срок оценки: The first day after surgery]

Вторичные конечные точки (12)

• The incidence of pain, numbness, soft tissue injury in other places [Срок оценки: The first day after surgery]
• Patients at discharge perineum area incidence of nerve injury [Срок оценки: 7 days after surgery]
• Intraoperative traction time [Срок оценки: During surgery (intraoperatively)]
• Preoperative preparation time [Срок оценки: Immediately before surgery (preoperatively)]
• Operating time [Срок оценки: During surgery (intraoperatively)]
• The average length of hospital stay after surgery [Срок оценки: 6 weeks after surgery]
• Postoperative joint function assessment [Срок оценки: 3 months after surgery]
• Postoperative joint function assessment [Срок оценки: 3 months after surgery]
• Postoperative joint function assessment [Срок оценки: 3 months after surgery]
• Postoperative joint function assessment [Срок оценки: 3 months after surgery]
• Economic Evaluation - Pain Intensity [Срок оценки: 14 days after surgery]
• Economic Evaluation - Hip Function [Срок оценки: 14 days after surgery]

Критерии участия

Критерии включения

• Aged 15 to 60 years;
• Met the diagnostic criteria of femoroacetabular impingement syndrome (FAI) and indicated for hip arthroscopy based on patient history, symptoms, signs, physical examination, imaging (pelvic anteroposterior view, frog-leg view, CT 3D reconstruction, MRI), and diagnostic injections;
• Able to read and sign the informed consent form.

Критерии исключения

• History of high-energy hip trauma, previous ipsilateral or contralateral hip surgery, avascular necrosis of the femoral head, slipped capital femoral epiphysis, Perthes disease, severe osteoporosis, tumors, acetabular stress fractures, or proliferative or immune hip diseases;
• Diseases causing groin numbness, foot numbness, sexual dysfunction, urinary dysfunction, skin injuries, perineal injuries, nerve injuries, radicular pain, inner or outer thigh numbness;
• Abnormal heart, lung, liver, kidney function, severe coagulation disorders, poorly controlled diabetes, judged by the researcher to have an infection risk;
• Consciousness disorders, psychiatric disorders, or neuromuscular dysfunction affecting lower limb function;
• Active infection foci (systemic or local infectious lesions);
• Pregnancy, lactation, or planned pregnancy during the clinical study period;
• Participation in another clinical trial within the past 3 months;
• Patients deemed unsuitable for the clinical trial by the researcher for other reasons.

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

Китай · 13 центров

• Beijing Jishuitan Hospital, Capital Medical University — Пекин
• Chinese PLA General Hospital — Пекин
• The Second Affiliated Hospital of Chongqing Medical University — Чунцин
• Shenzhen Second People's Hospital — Шэньчжэнь
• Luoyang Orthopedic Traumatological Hospital of Henan — Luoyang
• The Affiliated Drum Tower Hospital, Medical School of Nanjing University — Нанкин
• The Second Affiliated Hospital of Air Force Medical University (AFMU) — Сиань
• The Second Affiliated Hospital of Shandong First Medical University — Tai’an
• … и ещё 5 центров

Идентификаторы

NCT: NCT07322705 · 2024KY0158-KS001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗