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?
The FISH (Finnish Shaft of the Humerus) trial is an ongoing prospective, randomized controlled trial comparing the effectiveness and cost-effectiveness between surgery (open reduction and plate osteosynthesis) and nonoperative treatment (functional bracing) of humeral shaft fractures. 82 patients with humeral shaft fracture have been randomly assigned to surgery or to non-surgical treatment with functional bracing. We are following the patients for 10 years and comparing the results of the two groups at different time points.
FISH trial spinoffs
Over the years, we have expanded the scope of the FISH trial to include several subprojects and coined this entity the ‘FISH study’. So far, we have done an epidemiological study, PASS-MID -study on the most commonly used upper-extremity PROMs in humeral shaft fracture patients. Currently, we are working an a publication comparing the randomized and non-randomized FISH trial participants, a study on the prognostic perfomance of the RUSHU (Radiographic Union Score for HUmeral fractures) score, a study on the effect of fracture malunion on PROMs, and a study on prediction of treatment failure in humeral shaft fracture patients.
Where are we now?
The 1-, 2-, and 5-year follow-ups have been carried out and published. Currently, we are analyzing the cost-effectiveness data of the FISH trial, and the 10-year follow-up is still ongoing (completion in Jan 2028).
So far, we have published:
The protocol article of the trial in 2017
Results of the 1-year follow-up
Results of the 2-year follow-up
