Brace or ORIF for Humeral Shaft Fractures? Go FISH (Again)

FISH is a complicated tale, but an important one

What’s the Claim?

When a big randomized trial comes out showing no differences favoring surgery, the first thing surgeons look at is how many patients crossed over — that is, were randomized to something other than surgery, but somewhere along the way, threw in the towel and decided after randomization to have surgery despite their initial allocation to another group.

That occurred pretty often in the original Finnish Shaft of the Humerus (FISH) trial 4 years ago, which randomized patients to ORIF or functional bracing for closed humeral shaft fractures. It found no advantages in patient-reported outcomes scores favoring surgery, but 32% of patients randomized to the brace underwent secondary surgery, and at 2-year follow-up, they looked worse than those who were randomized to surgery initially or those who had successful bracing.

Now with 5 years of follow-up on the original RCT, those same authors are back with an interesting twist — although in aggregate there were no differences between surgery and bracing, a careful look at those who got a brace but did not heal and crossed over found that, within the 95% confidence intervals, there still could be a clinically important difference. In other words, though they couldn’t prove it, it’s possible that those who did not heal in the brace — which was a large subset of them (about one-third) — paid a price in terms of pain and function, even out to 5 years.

How’s It Stack Up?