Introduction Humeral shaft fractures account for 1–3% of all adult fractures. They are usually caused by simple falls, traffic accidents, and sports injuries. Historically, the treatment of these injuries has been mainly nonsurgical. However, there has been a marked increase in the rate of surgical treatment for humeral shaft fractures in recent years without high-quality evidence supporting this trend. Aim The Finnish Shaft of the Humerus (FISH) randomized clinical trial was planned to compare the effectiveness of surgery versus nonsurgical care in the treatment of humeral shaft fractures in patients traditionally deemed suitable for nonsurgical care with functional bracing (Study I). Patients and methods Patient recruitment was conducted at the Helsinki and Tampere University hospitals between November 2012 and January 2018. Consenting adult patients with displaced, closed, unilateral humeral shaft fractures were randomized to either surgical care using open reduction and plate fixation or nonsurgical care using functional bracing. Patients with a history or condition affecting the function of the injured upper limb, pathological fracture, other concomitant injury affecting the same upper limb, other trauma requiring surgery (e.g., fracture, internal organ, brachial plexus, or vascular injury), polytrauma, multimorbidity with high anesthesia risk, or inadequate cooperation for any reason were excluded. Altogether, 321 patients were assessed for eligibility and of these 140 were eligible for randomization. After informed consent, 82 were willing to undergo randomization. The primary outcome was the Disabilities of the Arm, Shoulder, and Hand (DASH) score (range, 0 to 100 points; 0 = no disability, 100 = extreme disability). In Study II, the patients were analyzed according to the initially allocated treatment method (surgery group and bracing group). In Study III, the patients were analyzed in three groups according to their final treatment method: 1) initial surgery group, 2) bracing group with successful healing, and 3) secondary surgery group including patients randomized to functional bracing but who underwent late surgery due to fracture healing problems. Results Study II. The mean DASH score was 8.9 (95% confidence interval [CI], 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group at 12 months. The between-group difference was -3.1 (95% CI, -9.6 to 3.3). This difference was not statistically significant, and it was below the predefined minimal clinically important difference of 10 points. Of the patients allocated to functional bracing, 13/44 (30%) underwent late surgery due to healing problem during the 12-month follow-up. In the post hoc analysis, the results of those with initial surgery were superior to those with late surgery due to healing problem (between-group difference, -11.1; 95% CI, -20.1 to -2.1) at 12 months. Study III. The mean DASH score was 6.8 (95% CI, 2.3 to 11.4) in the initial surgery group (n=38), 6.0 (95% CI, 1.0 to 11.0) in the bracing group (n=30), and 17.5 (95% CI, 10.5 to 24.5) in the secondary surgery group (n=14) at the 2-year follow-up. The between-group difference was -10.7 (95% CI, -19.1 to -2.3) between the initial and secondary surgery groups and -11.5 (95% CI, -20.1 to -2.9) between the bracing and secondary surgery groups. Conclusions Study II. Surgery with plate fixation, compared with functional bracing in the treatment of adult patients with closed humeral shaft fractures, did not significantly improve functional outcomes at 12 months. However, 30% of the patients allocated to functional bracing underwent late surgery due to healing problem. Study III. Shared decision-making between the clinicians and patients with closed humeral shaft fractures should weigh the prospect that 2/3 of patients undergo successful healing and have good functional outcomes using functional bracing against the 1/3 risk of fracture healing problems leading to secondary surgery and inferior outcomes even at 2 years after the injury.
|Tila||Julkaistu - 2021|
|OKM-julkaisutyyppi||G5 Tohtorinväitöskirja (artikkeli)|
LisätietojaM1 - 85 s. + liitteet
- 3126 Kirurgia, anestesiologia, tehohoito, radiologia