Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures

Официальное название

Prospective, Multicenter, Randomized Controlled Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures

Обзор

To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures

Вмешательства

• Процедура Sliding compression locking plate
  The patients with femoral neck fracture were treated with three cannulated compression screws or sliding compression locking plate.
• Процедура Three cannulated compression screws
  The patients with femoral neck fracture were treated with three cannulated compression screws.

Первичные конечные точки

• Femoral neck shortened [Срок оценки: 1 year]

Вторичные конечные точки (8)

• Neck shaft angle [Срок оценки: 1 year]
• The effectiveness of guide pin implantation [Срок оценки: 1 day]
• Time of operation [Срок оценки: 1 day]
• Blood loss [Срок оценки: 1 day]
• Bone union [Срок оценки: 1 year]
• Zarit Burden Interview（ZBI） [Срок оценки: 1 year]
• SF-36 Score [Срок оценки: 1 year]
• Harris Hip Score: [Срок оценки: hip function is assessed during outpatient follow-up at 1, 3, 6, and 12 months postoperatively using the Harris Hip Score system.]

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 · 3 центра

• the First Centre of PLA General Hospital — Пекин
• Chinese PLA General Hosptial — Пекин
• the First Medical Center of PLA General Hospital — Пекин

Идентификаторы

NCT: NCT06713291 · Chinese PLA General Hosptial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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