Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures

Официальное название

Prospective, Multicenter, Randomized Controlled Clinical Study of Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures

Обзор

The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures. Participants will: * Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures. * Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.

Вмешательства

• Процедура Three cannulated compression screws by navigation system
  Patients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system
• Процедура Traditional three cannulated compression screws
  Patients with femoral neck fractures treated with traditional three cannulated compression screws

Первичные конечные точки

• Perspective frequency [Срок оценки: 1 day]

Вторичные конечные точки (9)

• Neck shaft angle [Срок оценки: 1 year]
• Guide needle implantation effect [Срок оценки: 1 day]
• Fluoroscopy times of needle implantation [Срок оценки: 1 day]
• Operation time [Срок оценки: 1 day]
• Operative blood loss [Срок оценки: 1 day]
• Fracture union [Срок оценки: 1 year]
• Zarit Burden Interview score [Срок оценки: 1 year]
• Harris score [Срок оценки: 1 year]
• SF-36 score [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age ≥18 years old, gender is not limited;
• Patients diagnosed with femoral neck fracture;
• Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
• The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

Критерии исключения

• Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit;
• The patient is known to have a history of allergy to one or more implanted materials;
• Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
• Active infection of the hip joint or other parts of the body is determined by the investigator;
• Diagnosed as metabolic bone disease, radiation bone disease, etc.;
• Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
• have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
• The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;
• Other conditions deemed unsuitable for inclusion by the investigator.

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

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Публикации

• Li M, Tong D, Cheng M, Li J, Ji F, Zhang W. Navigation System-Assisted vs Freehand Cannulated Screw Fixation for Femoral Neck Fractures: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 23;15:e88180. doi: 10.2196/88180. PMID 42335459

Идентификаторы

NCT: NCT06713018 · S2024-341-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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