Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial

Abstract

Importance: Humeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend.

Objective: To compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures.

Design, setting, and participants: Randomized clinical trial conducted at 2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019. A total of 82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion. Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma.

Interventions: Patients were randomly assigned to surgical treatment with open reduction and internal plate fixation (n = 38) or to nonsurgical treatment with functional bracing (n = 44).

Main outcome and measure: The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 12 months (range, 0 to 100 points, 0 denotes no disability and 100 extreme disability; minimal clinically important difference, 10 points).

Results: Among 82 patients who were randomized (mean age, 48.9 years; 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial. Thirteen (30%) of the patients assigned to functional bracing underwent surgery during the 12-month follow-up period to promote healing of the fracture. At 12 months, the mean DASH score was 8.9 (95% CI, 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group (between-group difference, -3.1 points; 95% CI, -9.6 to 3.3; P = .34). Eleven patients (25%) allocated to functional bracing developed fracture nonunion. Three patients (8%) allocated to surgery developed a temporary radial nerve palsy.

Conclusions and relevance: Among patients with closed humeral shaft fracture, internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months. However, the substantial amount of treatment crossover from nonoperative to surgical treatment should be considered when interpreting the trial results.

Trial registration: ClinicalTrials.gov Identifier: NCT01719887.

Figure 1.. Enrollment, Randomization, and Analysis of Patients in the FISH Trial

^aThe reasons for exclusion are given in eTable 5 in Supplement 2. Patients could have had more than 1 reason for exclusion. ^bQualifying fractures had to be in the area delimited proximally by the superior border of the pectoralis major tendon attachment and distally by the line lying 5 cm from the upper border of the olecranon fossa as evaluated from the x-ray. ^cPatients who declined randomization were invited to participate in an observational cohort (declined cohort) that followed the study protocol and were treated according to their preference. ^dBlock randomization conducted in groups of 4 with stratification by status of radial nerve and fracture type. ^eThirteen patients randomized to the bracing group underwent surgery during the 12-month follow-up but were analyzed in the bracing group for the primary analysis. ^fAll randomized patients with any data were included in the primary analysis. See eTable 6 in Supplement 2 for details on missing data. ^gThe declined cohort was analyzed separately from the randomized cohort. All patients with any data were included in the analysis.

Figure 2.. Illustration of the Fracture Zone, Excluded Fracture Type, and a Functional Brace

Figure 3.. Disabilities of Arm, Shoulder and Hand Score Over Time

The colored error bars indicate 95% CIs of the point estimates of group means; boxes, 25th and 75th percentiles of observed values; horizontal lines within boxes, median Disabilities of Arm, Shoulder and Hand (DASH) scores; black error bars, highest and lowest values within 1.5 times the interquartile range; data points beyond the error bars, individual values outside of this range. The 13 patients in the bracing group who underwent surgery are included in the bracing group. The “before fracture” time point represents patients’ perception of their DASH score prior to fracture. One patient did not report the DASH score at baseline (eTable 6, footnote c); no imputation was performed for missing data (eTable 7 for data and eFigure 3 for parallel line plot [Supplement 2]).