FISH

FISH is a randomized controlled trial comparing surgical treatment with plate fixation and non-surgical treatment with functional bracing in patients with humeral shaft fracture.

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.

Where are we now?

The one- and two-year follow-up have been carried out and published. The final data entry for the five-year follow-up has been done in February 2023, the statistical analyses of the data is now underway and we intend to publish the data in the following months.

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 

Principal investigators

Lasse Rämö

MD, PhD, Orthopaedic Surgeon, Senior researcher

Mika Paavola

Deputy research director, chief surgeon, adjunct professor

Bakir O. Sumrein

MD, Orthopaedic surgeon

Vesa Lepola

MD, PhD, Orthopaedic surgeon

Simo Taimela

Adjunct professor, Research director

Project team

Teppo Järvinen, Prof – Jonas Ranstam, Prof – Tuomas Lähdeoja, MD

 

Contributors

Thomas Ibounig, MD – Eerik Hällfors, MD – Mikko Salmela, MD – Miia Mäntysaari, MD – Robert Björkenheim, MD – Cyrill Suter, MD – Henrik Mattila, MD – Antti Launonen, MD, PhD – Antti Malmivaara, MD, PhD – Pasi Aronen, statistician

Clinical research coordinators:

Leena Caravitis – Seija Rautiainen

Publications