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Original Investigation
April 14, 2021

Outcomes With Surgery vs Functional Bracing for Patients With Closed, Displaced Humeral Shaft Fractures and the Need for Secondary Surgery: A Prespecified Secondary Analysis of the FISH Randomized Clinical Trial

Author Affiliations
  • 1Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
  • 2Orthopedics and Traumatology, University of Tampere and Tampere University Hospital, Tampere, Finland
  • 3Mdas AB, Ystad, Sweden
JAMA Surg. Published online April 14, 2021. doi:10.1001/jamasurg.2021.0906
Key Points

Question  Do patients who require secondary surgery after initial nonoperative treatment of closed humeral shaft fracture have inferior outcomes compared with those who undergo uneventful fracture healing after initial operative or nonoperative treatment?

Findings  In this 2-year follow-up of the Finnish Shaft of the Humerus (FISH) randomized clinical trial comparing surgery with nonoperative functional treatment among 82 adults with humeral shaft fractures, 30 of 44 patients (68%) allocated to nonoperative treatment healed uneventfully with similar results as the patients undergoing initial surgery. However, the 2-year functional outcomes (group means using the Disabilities of Arm, Shoulder and Hand score; range, 0 to 100 points; minimal clinically important difference, 10 points) of patients who required secondary surgery (17.5 points) were statistically significantly inferior compared with those who underwent uneventful fracture healing after initial surgery (6.8 points) and after successful nonoperative functional bracing (6.0 points).

Meaning  Nonoperatively treated patients who experienced fracture healing problems that required secondary surgery had inferior outcomes at 2-year follow-up compared with patients whose fractures healed successfully, irrespective of whether the latter were initially treated with surgery or with functional bracing.

Abstract

Importance  Existing evidence indicates that surgery fails to provide superior functional outcome over nonoperative care in patients with a closed humeral shaft fracture. However, up to one-third of patients treated nonoperatively may require secondary surgery.

Objective  To compare the 2-year outcomes of patients who required secondary surgery with the outcomes of patients with successful initial treatment.

Design, Setting, and Participants  This 2-year follow-up of the Finnish Shaft of the Humerus (FISH) randomized clinical trial comparing surgery with nonoperative treatment (functional brace) was completed in January 2020. Enrollment in the original trial was between November 2012 and January 2018 at 2 university hospital trauma centers in Finland. A total of 321 adult patients with closed, displaced humeral shaft fracture were assessed for eligibility. After excluding patients with cognitive disabilities, multimorbidity, or multiple trauma and those refusing randomization, 82 patients were randomized.

Interventions  Interventions were surgery with plate fixation (n = 38; initial surgery group) or functional bracing (n = 44); the latter group was divided into the successful fracture healing group (n = 30; bracing group) and the secondary surgery group (n = 14) with fracture healing problems.

Main Outcomes and Measures  The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 2 years (range, 0 to 100 points; 0 denotes no disability, 100 extreme disability; minimal clinically important difference, 10 points).

Results  Of 82 randomized patients, 38 (46%) were female. The mean (SD) age was 48.9 (17.1) years. A total of 74 patients (90%) completed the 2-year follow-up. At 2 years, the mean DASH score was 6.8 (95% CI, 2.3 to 11.4) in the initial surgery group, 6.0 (95% CI, 1.0 to 11.0) in the bracing group, and 17.5 (95% CI, 10.5 to 24.5) in the secondary surgery group. The between-group difference was −10.7 points (95% CI, −19.1 to −2.3; P = .01) between the initial and secondary surgery groups and −11.5 points (95% CI, −20.1 to −2.9; P = .009) between the bracing group and secondary surgery group.

Conclusions and Relevance  Patients contemplating treatment for closed humeral shaft fracture should be informed that two-thirds of patients treated with functional bracing may heal successfully while one-third may experience fracture healing problems that require secondary surgery and lead to inferior functional outcomes 2 years after the injury.

Trial Registration  ClinicalTrials.gov Identifier: NCT01719887

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