Orthopaedic surgeons and their staffs are aware of the paradigm shift that has taken place in the last 10 to 15 years regarding the treatment of clavicle fractures. Interest in the outcome differences between surgical and nonsurgical treatment has grown substantially since the 2007 Canadian Orthopaedic Trauma Society publication in JBJS showed that, relative to nonoperative treatment, plate fixation of displaced midshaft clavicle fractures resulted in improved functional outcomes and fewer malunions in active adult patients. Since that time, The Journal alone has published 14 articles related to management of clavicle fractures. In addition, the orthopaedic literature contains a number of well-conducted meta-analyses on the topic, comparing both nonoperative and surgical treatment as well as different methods of surgical fixation.
So, with all this evidence, why have we published the randomized controlled trial on this topic by King et al. in the April 3, 2019 issue of The Journal? Partly because the authors build upon our knowledge by comparing a relatively new fixation device (a flexible intramedullary locked nail) to a more standard treatment (an anatomically contoured plate). These plate and nail devices are very different from one another in terms of mechanics and surgical technique, and the flexible nail used in this study is much different than the rigid, straight nails or pins that have been used in the past.
A union rate of 100% was observed in both groups, but the authors found that the flexible nail was significantly faster in terms of operative time. (A single surgeon experienced with both devices performed all 72 surgeries.) They also found that the DASH scores between the groups were similar until the 12 month follow-up, at which point the flexible intramedullary nail group had statistically better scores. The authors concede, however, that the 12-month DASH-score difference “might not be clinically relevant.”
There is one other reason why we deemed this article important: The flexible intramedullary device used in this study is substantially more expensive than prior fixation devices that have been shown to effectively treat clavicular fractures. King et al. did not compare device costs, but whenever we study a device that adds to the total cost of care we should attempt to prove that it adds enough patient benefit to warrant the added expense. As the authors conclude, both devices evaluated in this study appear to be effective at treating displaced/shortened clavicular fractures, and there are a number of other factors that both the surgeon and patient should consider (such as surgeon skill and experience and cosmetic results) when deciding which treatment to use.
Marc Swiontkowski, MD
3 thoughts on “Clavicle Fracture Research: Enough Already?”
First of all, thank you for discussing our paper. There are always multiple ways to look at an article, as in this case. Overall, similar results were found when treating the clavicle fracture with a plate or the flexible nail. However, it is important to note that less variation in the outcome results were found when using the flexible nail, while a wider treatment response was found when using a plate. Although no significant differences were found, slightly better Cohen effect sizes were found when using a nail. Overall both devices have pros and cons. The biggest advantage of nailing in our setting (South African public hospital) is a lower infection rate (likely due to smaller incision sizes) and fewer requests for hardware removal. With the majority of our patients coming from lower social/income classes and limited available theatre time in our hospital, these advantage can outweigh the slightly higher costs of the nail in our setting. In conclusion, multiple factors should be taken into account when choosing either plate or nail when treating clavicle fractures, as also pointed out by Dr. Swiontkowski. Kind regards, Prof. Dr. Rob Lamberts
“Interest in the outcome differences between surgical and nonsurgical treatment has grown substantially since the 2007 Canadian Orthopaedic Trauma Society publication in JBJS showed that, relative to nonoperative treatment, plate fixation of displaced midshaft clavicle fractures resulted in improved functional outcomes and fewer malunions in active adult patients. Since that time, The Journal alone has published 14 articles related to management of clavicle fractures. In addition, the orthopaedic literature contains a number of well-conducted meta-analyses on the topic, comparing both nonoperative and surgical treatment as well as different methods of surgical fixation.”
From this commentary, Dr. Swiontkowski appears to suggest that there is no longer any controversy regarding the treatment of displaced clavicle fractures by plate fixation.
My stance on this approach is well documented.(ref 1)
No doubt, plate fixation of displaced midshaft clavicle fractures is found to be associated with improved functional outcomes and fewer malunions in active adult patients. However, this fact does not obviate the need for a well-informed discussion in which “the choice to proceed with operative intervention for a displaced mid-shaft fracture of the clavicle will be a decision made between surgeon and patient.” (ref 2)
Furthermore, the economic assessment provided by Robinson et al remains unchallenged (ref 3) after all these years; the overall cost of treatment in non-operative group is lower, even when more expensive secondary reconstructive procedures are included in the analysis of patients initially managed nonoperatively who subsequently require corrective surgery.
As McKee had pointed out (ref 4), the number needed to treat (NNT) to prevent a nonunion/malunion complication is between 4.6 to 6.2; that means between 3 to 4 out of every 5 displaced midshaft clavicle fracture fixed with plate would not have made any difference to the clinical outcome for the patient.
I do not know many fracture fixation operations that have similarly sobering statistics.
Furthermore, at least 1 out of every 8 patient with plate fixation requires plate removal. Again, I am not aware of another operation which requires implant removal at this high rate. It is obviously not a simple matter of “implant choice” or “surgical technique” here.
In fact, 2 recent papers published in JBJS did not give carte blanche to supporters of routine operative fixation.
Woltz in 2017 concludes, “Plate fixation significantly reduces the risk of nonunion, but does not have a clinically relevant advantage regarding final functional outcome. Secondary operations are common after both treatments. Overall, there is not enough evidence to support routine operative treatment for all patients with a displaced midshaft clavicular fracture.”
While Liu et al admits “Operative treatment is more cost-effective than nonoperative treatment for substantially displaced midshaft clavicle fractures,” she cautioned: “The clinical benefits derived with operative treatment must persist for at least 3 years for operative treatment to remain cost-effective. This research should not be used to conclude that all clavicle fractures should be treated surgically. It is best that such a decision is made through a patient-surgeon shared decision-making process.”
Foregone conclusion? Not so.
2. McKee MD The Operative versus Non-operative Treatment of Common Upper Extremity Injuries: What Does Evidence Based Medicine Tell Us?
Fractures of the Clavicle. OTA Annual Meeting Oct 12, 2013. http://ota.org/media/78916/12-McKee.pdf Accessed April 4, 2019
3. Robinson CM et al. Open Reduction and Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular Fractures A Multicenter, Randomized, Controlled Trial. J Bone Joint Surg Am. 2013;95:1576-84
4. McKee MD. Displaced Fractures of the Clavicle: Who Should Be Fixed? J Bone Joint Surg Am. 2013;95:e129(1-2)
5. Woltz S et al. Plate Fixation Versus Nonoperative Treatment for Displaced Midshaft Clavicular Fractures: A Meta-Analysis of Randomized Controlled Trials.J Bone Joint Surg Am. 2017;99: 1051-1057
6. Liu J et al. Cost-Effectiveness of Operative Versus Nonoperative Treatment of Displaced Midshaft Clavicle Fractures: A Decision Analysis.J Bone Joint Surg Am. 2019;101:35-47
Could not the same be said for much of the orthopedic literature: dvt, tja,acl, orif including hips, pain management?