This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment

Официальное название

Treatment of Olecranon Fractures in the Elderly, a Randomised Controlled Trial Comparing Surgical and Conservative Treatment

Обзор

This study takes place in one hospital and uses a random method to divide patients into groups. It looks at the best way to treat a broken elbow (specifically, a displaced olecranon fracture) in older adults who don't use their arms heavily. There are 84 patients in total, with 42 people in each group

Вмешательства

• Процедура Open reduction and plate osteosynthesis
  A cut is made along the back of the elbow to reach the broken bone. The surgeon carefully moves tissues aside and protects nearby nerves. The broken bone is cleaned, realigned, and held in place with a special metal plate and screws. This helps support the bone, especially in older patients with fragile bones. The surgeon checks the placement using live X-ray and moves the arm to ensure stability. The area is then closed with stitches, bandaged, and sometimes supported with a light splint. Rec
• Другое Conservative treatment with early mobilisation
  Conservativel treatment usually involves wearing a sling or light support for about two weeks to manage pain. After that, the patient begins gentle, supervised arm movements to prevent stiffness and muscle loss. As the pain improves, exercises become more active and focused on regaining strength. The goal is to let the bone heal while keeping the elbow working well.

Первичные конечные точки

• between-group difference in the Oxford Elbow Score (Italian Version) with the subscales Function, Pain, and Social-Psychological [Срок оценки: 6 months after injury]

Критерии участия

Критерии включения

• Patients with an acute (< 2 weeks) Mayo type 2A or 2B olecranon fracture
• Patients aged > 65 years • Patients with reduced functional demand, with a score > 2 and < 7 on the Clinical Frailty Scale
• Patients able to provide informed consent and follow all study procedures as indicated in the protocol
• Signed informed consent for study participation

Критерии исключения

• Patients aged < 65 years or with a Clinical Frailty Scale score > 7 or < 2
• Patients with a Mayo type 2A or 2B fracture seen more than 2 weeks after injury
• Old fracture (> 6 months), pseudoarthrosis, or unhealed nerve injury of the ipsilateral upper limb
• Open (Gustilo-Anderson type 2 or 3) or pathological fracture
• Previous injury to, or other condition of, the elbow with severe functional impairment
• Patients with severe comorbidities preventing safe surgical treatment
• Other acute fracture or nerve damage of the ipsilateral upper limb
• Known drug or alcohol abuse
• Inability to follow study procedures (e.g., due to language barriers or severe comorbidities)

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

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• EOC - Orthopaedics and Traumatology Service — Lugano

Идентификаторы

NCT: NCT07400692 · ORL-ORT-049

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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