FISH

Surgery vs. Functional bracing for humeral shaft fracture

Project timeline

Study design

RCT

Status

Follow-up & reporting

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 protocol article of the trial in 2017

Results of the 1-year follow-up

Results of the 2-year follow-up

Results of the 5-year follow-up

MID-PASS publication

Epidemiological study

Principal investigators

Project team

Cyrill Suter – Henrik Mattila – Thomas Ibounig – Tuomas Lähdeoja – Vesa Lepola – Antti Launonen – Eerik Hällfors – Mikko Salmela – Miia Mäntysaari – Robert Björkenheim – Antti Malmivaara – Pasi Aronen – Aleksi Reito – Tomasz Czuba – Jonas Ranstam – Teppo Järvinen

Clinical research coordinators

Leena Caravitis – Seija Rautiainen

News

Publications

JB & JS Open Access, 2024 Dec 2

Thomas Ibounig, Cyrill Suter, Bakir Sumrein, Antti Launonen, Tomasz Czuba, Teppo Järvinen, Simo Taimela, Mika Paavola, Lasse Rämö

JAMA 2024, March 4

Lasse Rämö, Thomas Ibounig, Bakir O. Sumrein, Vesa Lepola, Mika Paavola, Simo Taimela, Teppo Järvinen

J SHOULDER ELBOW SURG, 2022 NOV 23

Henrik Mattila, Topias Keskitalo, Tomi Simons, Thomas Ibounig, Lasse Rämö

BMC MED RES METHODOL, 2022 NOV 10

Thomas Ibounig, Joona Juurakko, Tuomas Lähdeoja, Bakir Sumrein, Teppo Järvinen, Mika Paavola, Clare Ardern, Teemu Karjalainen, Simo Taimela, Lasse Rämö

JAMA, 2020 May 12

Lasse Rämö, Bakir Sumrein, Vesa Lepola, Tuomas Lähdeoja, Jonas Ranstam, Mika Paavola, Teppo Järvinen, Simo Taimela

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