Why is this trial needed?
Humeral shaft fractures account for 1%–3% of all fractures. There is approximately 60000 emergency department visits annually due to humeral shaft fracture in the United States alone.
The majority of humeral shaft fractures have traditionally been treated nonoperatively while surgery has been reserved for more complex cases. The outcome of nonoperative treatment has generally been reported to be good, but concerns have been expressed with regards to the rate of non-unions that has been shown to be as high as 33% in some studies. In contrast, the rate of union after surgical treatment has been as high as 98%, but surgery is inherently related to certain complications, such as infection and iatrogenic radial nerve palsy
The paucity of high-quality evidence to inform the most appropriate treatment choices has resulted in a marked increase in the surgical treatment of humeral shaft fractures in the past two decades. There is, however, little evidence to support this evolution.
What is the primary objective of the FISH study?
We aim to carry out a prospective, randomized comparison between surgery (open reduction and plate osteosynthesis) and nonoperative treatment (functional bracing) in the treatment of patients with humeral shaft fracture.
Where are we now?
The trial is conducted as a collaborative initiative between the Helsinki and Tampere University Hospitals.We launched the trial in 2012 and completed recruitment in January 2018.
So far, we have published:
The manuscript of the 2-year follow-up is under preparation.