Radiographs of a 14-year-old male who presented to the emergency department with a completely displaced right midshaft clavicle fracture with a butterfly fragment and 2 cm of shortening after a contact injury while playing football (A) and who underwent a nonsurgical course of treatment. Appropriate bony remodeling is seen at six months post-injury (B), continuing at more than three years after initial injury (C).
Courtesy of Benton E. Heyworth, MD

AAOS Now

Published 11/30/2019
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Terry Stanton

Study Favors Nonoperative Management of Clavicle Fractures in Adolescents

A study presented at the Orthopaedic Trauma Society Annual Meeting found that surgery offered no significant advantage over nonoperative management in the major outcome categories assessed in adolescent patients with clavicle fractures.

The study, presented by Benton E. Heyworth, MD, FAAOS, of Boston Children’s Hospital, followed a final group of 267 patients with midshaft clavicle fractures and found no outcome advantages at two years for the 82 patients (31 percent) who underwent surgery versus the nonsurgical group in terms of functional measures, satisfaction, activity levels, or complication rates. Overall, operative patients were significantly more likely to sustain a complication (P < 0.001) or undergo a secondary operation (P = 0.0006), even when sensory deficits were excluded (P < 0.0004). Nonunion (0.2 percent of cases), delayed union (1.7 percent), and symptomatic malunion (0.5 percent) were exceedingly rare events, with no differences observed between treatment groups.

Dr. Heyworth said the two major findings of the study were:

  1. The two most common complications of nonoperative treatment cited in the literature regarding adult clavicle fractures—nonunion and symptomatic malunion—were observed in less than 1 percent of the adolescent nonoperative cohort (compared to 15 percent and 10 percent, respectively, in most adult meta-analyses).
  2. Even when the researchers applied matching and regression techniques to more precisely compare subgroups in the Function After Adolescent Clavicle Trauma and Surgery (FACTS) operative and nonoperative treatment groups—in an attempt to eliminate confounding treatment selection criteria and compare “apples to apples”—no difference was seen between the groups in terms of two-year function, satisfaction, or activity levels.

Dr. Heyworth and coauthors explained that although controversy remains regarding the optimal treatment approach or algorithm for displaced clavicle shaft fractures, “meta-analyses and systematic reviews have made clear that the two most clinically significant risks of nonoperative treatment are nonunion and symptomatic malunion, which arise at approximate rates of 15 percent and 10 percent, respectively. Meanwhile, the most clinically significant risk of operative treatment appears to be painful hardware requiring secondary removal treatment, which arises in 15 [percent] to 20 percent of surgical patients.”

The authors noted that most of the studies have been performed in adult populations; relatively few have evaluated pediatric and adolescent cohorts. The adolescent studies that have emerged primarily consisted of retrospective series with small sample sizes and few comparative cohorts.

Adolescents versus adults

Although surgery was established as a relatively safe treatment approach for this age group, rates of symptomatic hardware and removal were comparable to or greater than rates reported in adults. “Moreover, even the largest cohorts of nonoperatively treated adolescents demonstrated rates of nonunion and symptomatic malunion substantially lower than those in adults,” the authors noted. “Additionally, criteria that have been identified in adult studies as risk factors for nonunion and symptomatic malunion, such as comminution and fracture shortening, do not appear to adversely influence outcomes in adolescents in [a] similar fashion, with good strength and functional outcome scores reported in adolescents with severe fracture shortening who were assessed at follow-up points well beyond healing. While still limited to single centers and relatively small numbers of patients, adolescent studies have demonstrated equivalent patient-reported outcomes and significantly higher complication rates with surgery when compared to no surgery.”

Dr. Heyworth explained that despite such evidence suggesting fairly distinct natural histories of clavicle fracture healing between adults and adolescents, “Caregivers of adolescent populations have followed the trend toward surgical treatment in the last decade or so.” A survey of Pediatric Orthopaedic Society of North America surgeons illustrated that adult studies, such as a 2007 randomized, controlled trial (RCT), were among the most influential factors in treatment decision-making. “As a result, multiple studies have shown significant increases in the rates and volume of adolescent patients being treated with fixation,” the authors wrote.

The present study was conducted among surgeon-investigators from eight different pediatric centers who established a multicenter study group (FACTS) designed to prospectively compare outcomes following operative versus nonoperative treatment, with a focus on outcomes of the subset of completely displaced fractures. At each study institution, patients were not required to seek care with one of the study investigators; any orthopaedic or sports medicine professional could be the primary caregiver for the clavicle fracture, provided he or she was willing to allow the patient to participate in the study.

Radiographs of a 14-year-old male who presented to the emergency department with a completely displaced right midshaft clavicle fracture with a butterfly fragment and 2 cm of shortening after a contact injury while playing football (A) and who underwent a nonsurgical course of treatment. Appropriate bony remodeling is seen at six months post-injury (B), continuing at more than three years after initial injury (C).
Courtesy of Benton E. Heyworth, MD
Benton E. Heyworth, MD

Radiographic views at all follow-up time points through time of healing included two views of the clavicle on the affected shoulder: an anteroposterior view and a cephalad view, ranging from 15 degrees to 30 degrees cephalad, depending on the institutional standard for clavicle assessment. Bony healing was assessed radiographically, with caregivers at study institutions encouraged at study outset to consider CT scans for suspected or equivocal cases of delayed union or nonunion, particularly if a change in treatment would be considered for such patients.

Validated, shoulder-specific functional outcome measures and activity surveys (including the American Shoulder and Elbow Surgeons score; short-form version of Disabilities of the Arm, Shoulder, and Hand score; Marx Shoulder Activity score; and global health, quality-of-life, and five-scale satisfaction score) were obtained at six-, 12-, and 24-month follow-up time points, with standard “windows” or time durations around each follow-up point.

Rates of delayed union were not significantly different (P = 0.37) between operative (2.4 percent) and nonoperative (1.4 percent) treatment groups, although one operative patient underwent revision plate fixation to address slow healing. As previously noted, complications were significantly less common in nonoperative (5.5 percent) versus operative (40.8 percent, P < 0.0001) patients—a difference that was maintained when sensory deficits (all of which were Clavien-Dindo “level 1” complications) were excluded (5.1 percent versus 15.2 percent, P = 0.0004). There were significantly more secondary surgeries in the operative group (6.4 percent) than the nonoperative group (1.0 percent, P = 0.0006).

‘Vastly different’ algorithms

The authors noted that the two most significant complications, or causes of suboptimal function, following nonoperative treatment in adults—nonunion and symptomatic malunion—were exceedingly rare in the current adolescent population. They also noted that delayed union, defined in the study as failure to show a radiographically healed fracture three to six months after injury, “is another complication along the same spectrum of suboptimal healing as nonunion, and may be particularly relevant to the adolescent subpopulation, who show greater baseline activity levels than their adult counterparts and are often anxious to return to sports and full activity soon after injury. These marked differences in the natural history of clavicle fracture healing between adults and adolescents may be more intuitive than recent trends toward adolescent clavicle surgery might suggest, as fracture treatment algorithms are vastly different between these subpopulations for a variety of other common fractures, such as tibia fractures and distal radius fractures.”

The clinical takeaway of the study, Dr. Heyworth said, is that “Nonoperative treatment of completely displaced clavicle fractures appears to have an exceedingly low risk of complications and suboptimal shoulder function two years post-injury and may be preferred as a first-line treatment to surgery.”

Limitations of the study include: “While the FACTS study represents a level 2 study, which is prospective comparative research, there are some factors of selection bias at work in the two treatment groups. While we tried to control for this in the analysis, a level 1 study, or prospective RCT, may have better avoided some of these forms of bias. How ethical an RCT in children might be, given some of the findings of this research, is somewhat debatable now.”

Dr. Heyworth’s coauthors of “Two-year functional outcomes of operative versus nonoperative treatment of completely displaced midshaft clavicle fractures in adolescents: Results from the prospective, multi-center, level-two ‘FACTS’ study” are Andrew Pennock, MD; Ying Li, MD; Elizabeth S. Liotta, MBBS; Brittany Dragonetti, MA; David Williams, PhD; Henry B. Ellis, MD; Jeffrey Nepple, MD; Cliff Willimon, MD; Crystal Perkins, MD; David Spence, MD; Nirav Pandya, MD; Mininder Kocher, MD, MPH; Eric Edmonds, MD; Frances Farley, MD; Philip Wilson, MD; Michael Busch, MD; Coleen Sabatini, MD; and Donald S. Bae, MD.

Terry Stanton is the senior science writer for AAOS Now. He can be reached at tstanton@aaos.org.