Abstract
Objectives:
To investigate the two-year functional outcomes and complications following operative versus non-operative treatment of completely displaced midshaft clavicle fractures in adolescents.
Methods:
All patients 10-18 years-old treated for a midshaft clavicle fracture between August, 2013 and August, 2018 at one of 8 geographically diverse, high-volume, tertiary-care pediatric centers were enrolled, with independent treatment decisions determined by individual providers. The sub-population of patients with completely displaced fractures was prospectively followed for over 2 years. Clinical course, complications, validated patient-reported outcome measures (PROs), quality of life metrics, and satisfaction scores were analyzed. To address the ceiling effect of the PRO/satisfaction data following clavicle injuries, a priori thresholds for ‘suboptimal’ scores were established (ASES scores <90, QuickDASH scores >10, EQ-5D <0.80). According to ‘intention to treat’ statistical principles, one post-operative complication (and a subsequent secondary operation) was analyzed within the non-operative cohort, given that the patient represented a ‘crossover’ from the non-operative to the operative treatment group.
Results:
Of the 909 patients enrolled in the prospective study, 417 patients (45.9%) demonstrated completely displaced fractures and maintained enrollment over the study period, 277 (66%) of whom had reached two year follow up, and 151 of whom provided adequate PRO data, representing a 55% response rate. Of these patients, 55 (36%) underwent operative treatment, while 96 (64%) were treated non-operatively. Those treated surgically showed no difference in gender distribution (76% males,p=0.43), athletic participation (p=0.76), or fracture pattern (p=0.18), but were older (mean age 15.3 vs. 13.5 years, p<0.001) and had greater shortening (p<0.001) than those treated non-operatively. Within the subset with adequate complication data, listed in Figure 1, complications were less common in non-surgical than surgical patients (p=0.0003), but this difference did not reach significance when sensory deficits were excluded (p=0.17). There was no difference in secondary surgeries (p=0.43). While greater percentages of operative than non-operative patients reported suboptimal PRO/satisfaction scores (ASES: 15% vs. 5%, QuickDASH 11% vs 5%, satisfaction 11% vs. 5%), these differences did not reach significance (p=0.07, 0.20, 0.06, respectively).
Conclusion:
At eight large pediatric centers with many surgeons making independent treatment decisions, non-operative treatment of adolescent clavicle fractures demonstrated lower complication rates and similar satisfaction and functional outcomes.These data establish a comprehensive functional assessment of adolescents treated for clavicle fractures, which represents the epidemiological sub-population most affected by this condition. Unlike several adult studies demonstrating superiority in operative treatment, this adolescent study demonstrates equivalent function and fewer complications associated with non-operative treatment.
Complications of Completely Displaced Midshaft Clavicle Fractures with 2-Year Follow-Up
| Complication | Surgical (N=53) | Clinical Outcome | Non-Surgical (N=87) | Clinical Outcome | p-value |
|---|---|---|---|---|---|
| n (%) | n (%) | ||||
| Hardware pain/irritation | 5 (9.4%) | 2 out of 5 (40%;3.8% overall): ROH surgery (mean 21.5 months post-op)$ | 1 (1.1%) | ‘Crossover’ patient: ORIF 2 months post-injury → ROH surgery 10 months post-op | 0.03 |
| Sensory symptoms | 13 (24.5%) | Numbness distal to incision (resolution reported in 5 out of 13, 38%, mean 6 months post-op) | 1 (1.1%) | Occasional paresthesias (6mo post-op) → spontaneous resolution | <0.0001 |
| Superficial Infection | 0 (0.0%) | 0 (0.0%) | n/a | ||
| Deep Infection | 0 (0.0%) | 0 (0.0%) | n/a | ||
| Delayed Union | 2 (3.8%) | Patient 1: bone stimulator (6 months post-op) → healing Patient 2: Revision ORIF → healed | 2 (2.3%) | Both patients: non-operative treatment → healed | n/a |
| Non-union | 0 (0.0%) | 0 (0.0%) | n/a | ||
| Symptomatic Malunion | 0 (0.0%) | 2 (2.3%) | Patient 1: PT → improvement Patient 2: operative exostosis for bony prominence → resolution | n/a | |
| Refracture | 1 (1.9%) | 2 wks following ROH → healed w/ non-operative tx | 2 (2.3%) | Both patients: non-operative treatment → healed | n/a |
| Other described below) | 3 (5.7%) | 0 (0.0%) | n/a | ||
| Atlanto-axial rotatory subluxation (immediately postoperative) | 1 (1.9%) | Unresponsive to halo traction → C1-2 fusion | 0 (0.0%) | n/a | |
| Intra-operative blood loss (1 liter) —* urgent vascular surgery consultation | 1 (1.9%) | Ligation of cephalic vein branch | 0 (0.0%) | n/a | |
| Development of acromioclavicular (AC) joint ganglion cyst (4 mo post-op) | 1 (1.9%) | US-guided AC joint aspiration, injection (7 mo post-op)# | 0 (0.0%) | n/a | |
| Any secondary operation | 4 (7.5%) | 3 (3.4%) | 0.43 | ||
| Any Complication | 19 (35.8%) | 8 (9.2%) | 0.0003 | ||
| Any Complication (excluding ‘Sensory’) | 9 (17.0%) | 7 (8.0%) | 0.17 |
$ ROH = removal of hardware
*PT = physical therapy
#US = ultrasound