Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Jan 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical methods for fixing broken collarbones, specifically in the middle part of the bone, known as the midshaft. One method uses a single pre-shaped plate, while the other method uses two smaller plates. The goal of the study is to see if using the two smaller plates leads to fewer patients needing to have their plates removed later, while still ensuring the bone heals properly and there are no more complications.

To participate in this trial, individuals must be between 18 and 65 years old and have a completely displaced midshaft clavicle fracture, meaning the broken pieces of the bone do not touch at all. Participants will undergo surgery with one of the two methods and will be monitored during their recovery. This study is important because many patients experience discomfort from the plates used in surgery, and finding a more effective method could help reduce the need for additional procedures in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Between 18 and 65 years of age
• • A completely displaced midshaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments (AO/OTA 15.2A/B/C)
• • Fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment
• Exclusion Criteria:
• • Open fracture
• • Pathological fracture
• • Fracture seen \> 28 days after injury
• • Associated neurovascular injury
• • Associated head injury (Glasgow Coma Scale \< 12)
• • Concomitant ipsilateral upper extremity fracture
• • Significant medical comorbidities (i.e., ASA grade IV and V)
• • Inability to comply with follow-up and
• • Lack of consent