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NCT07400692
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
Conditions: Olecranon Fracture
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: Ente Ospedaliero Cantonale, Bellinzona
Location: EOC - Orthopaedics and Traumatology Service Lugano
Summary
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
Eligibility Criteria
Inclusion Criteria
* 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
Exclusion criteria:
* 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)
Source: ClinicalTrials.gov (NCT07400692). StuddyBuddy aggregates publicly available trial information.