Two-Year Functional Outcomes of Operative vs Nonoperative Treatment of Completely Displaced Midshaft Clavicle Fractures in Adolescents: Results From the Prospective Multicenter FACTS Study Group

Abstract

Background: The optimal treatment of midshaft clavicle fractures is controversial. Few previous comparative functional outcome studies have investigated these fractures in adolescents, the most commonly affected epidemiologic subpopulation. Purpose/Hypothesis: The purpose was to prospectively compare the outcomes of operative versus nonoperative treatment in adolescents with completely displaced midshaft clavicle fractures. The study hypothesis was that surgery would yield superior outcomes. Study Design: Cohort study; Level of evidence, 2. Methods: Patients aged 10 to 18 years treated for a midshaft clavicle fracture over a 5-year period at 1 of 8 pediatric centers were prospectively screened, with independent treatment decisions determined by individual musculoskeletal professionals. Demographics, radiographic clinical features, complications, and patient-reported outcomes (PROs) were prospectively recorded for 2 years. Regression and matching techniques were utilized to adjust for potential age- and fracture severity–based confounders for creation of comparable subgroups for analysis. Results: Of 416 adolescents with completely displaced midshaft clavicle fractures, 282 (68) provided 2-year PRO data. Operative patients (n = 88; 31%) demonstrated no difference in sex (78% male) or athletic participation but were older (mean age, 15.2 vs 13.5 years; P < .001), had more comminuted fractures (49.4% vs 26.3%; P < .001), and had greater fracture shortening (25.5 vs 20.7 mm; P < .001) than nonoperative patients (n = 194; 69%). There was no difference in mean PRO scores or rates of “suboptimal” scores (based on threshold values established a priori) between the operative and nonoperative treatment groups (American Shoulder and Elbow Surgeons, 96.8 vs 98.4; shortened version of the Disabilities of the Arm, Shoulder and Hand, 3.0 vs 1.6; EuroQol [EQ] visual analog scale, 93.0 vs 93.9; EQ–5 Dimensions index, 0.96 vs 0.98), even after regression and matching techniques adjusted for confounders. Operative patients had more unexpected subsequent surgery (10.4% vs 1.4%; P = .004) and clinically significant complications (20.8% vs 5.2%; P = .001). Overall, nonunion (0.4%), delayed union (1.9%), symptomatic malunion (0.4%), and refracture (2.6%) were exceedingly rare, with no difference between treatment groups. Conclusion: Surgery demonstrated no benefit in patient-reported quality of life, satisfaction, shoulder-specific function, or prevention of complications after completely displaced clavicle shaft fractures in adolescents at 2 years after injury. Registration: NCT04250415 ( ClinicalTrials.gov identifier).

Evaluation and Management of Midshaft Clavicle Fractures in Adolescents

“…53 More recent prospective work has estimated the rate of nonunion to be around 0.4% in adolescents. 54 Therefore, while operative indications and techniques honed in adult populations have been increasingly applied to adolescents, the primary justification for performing surgery may not be applicable in this younger age group. Symptomatic malunion after conservative management has similarly been more deeply explored in the last 1-2 decades.…”

“…73,74 In recently presented data from the FACTS registry of adolescent clavicle fractures, 40% of 125 operatively treated patients reported at least one complication after surgery. 54 When nonunions and symptomatic malunions occur with conservative treatment, delayed surgical fixation represents a feasible option without a suggestion of long-term morbidity or disability from the delay. Corrective osteotomy, bone grafting, and plate fixation have led to good clinical outcomes with high patient satisfaction in adult populations.…”

“…Plate fixation and intramedullary nailing have both been shown to lead to satisfactory results, 11,[81][82] and patientreported outcomes appear to be similar between operative and nonoperative management in children and adolescents. 54,62,73 Return to Sports…”

“…Heyworth et al described six refractures (2.1%) in a group of adolescents treated nonoperatively, with no subsequent surgery required. In contrast, five patients in the operative group sustained refracture (4%), three of whom underwent subsequent surgery 54. …”

Shoulder & Elbow

“…This prospective, multicentre cohort study performed by a group from Boston (Massachusetts, USA) is presented in this paper with the study hypothesis that surgery would result in superior outcomes. 3 Patients between the age of ten and 18 years were screened in eight paediatric centres over a five-year period. Injuries, which comprised a completely displaced midshaft clavicle fracture, were studied; patients were counselled and independent decisions made in conjunction with their treating surgeon.…”