Clavicle fracture. Fracture of clavicle
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Fracture of the middle third of the clavicle with lack of contact between the main fragments on the initial X-ray
Exclusion criteria
Exclusion criteria: Bilateral clavicle fracture Imminent risk of skin perforation by bone fragments Open fracture Associated vascular or nerve injury Unstable fracture of the scapular neck (“floating shoulder”) Concomitant fracture of the upper limb distal to the shoulder Pathological fracture History of unilateral or bilateral shoulder problems prior to the fracture Diagnosis of fracture more than 14 days after the injury Conditions leading to non-compliance with the treatment protocol (e.g., psychiatric disorders or substance abuse) Inability to ensure timely follow-up and patient visits History of clavicle fracture at age 15 or older
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic nonunion. Timepoint: Patients will be followed up and evaluated clinically and radiographically at 1, 3, and 6 months after the fracture. Method of measurement: This variable will be assessed based on radiographic imaging and the absence of bone union at the fracture site during follow-up visits.;Functional assessment. Timepoint: Patients will be followed up and evaluated clinically and radiographically at 1, 3, and 6 months after the fracture. Method of measurement: Shoulder and upper limb function of each patient will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.;Patient pain scale. Timepoint: Patients will be followed up and evaluated clinically and radiographically at 1, 3, and 6 months after the fracture. Method of measurement: Patient pain will be assessed using the Visual Analog Scale (VAS), a single-item measure ranging from 0 to 10 (0 = no pain, 10 = worst pain).;Revision surgery rate. Timepoint: Patients will be followed up and evaluated clinically and radiographically at 1, 3, and 6 months after the fracture. Method of measurement: The number and percentage of patients requiring additional surgical intervention due to complications or unsatisfactory treatment outcomes will be recorded and reported. | — |
Countries
Iran (Islamic Republic of)
Contacts
Kerman University of Medical Sciences