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Frequency and complications after operative fixation of clavicular fractures
ARTICLE IN PRESS J Shoulder Elbow Surg (2016) ■■, ■■–■■
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Frequency and complications after operative fixation of clavicular fractures Ronald A. Navarro, MDa,*, Jonathan D. Gelber, MDb, John J. Harrast, MSc, John G. Seiler III, MDd, Kent R. Jackson, MDa, Ivan A. Garcia, MDe a
Department of Orthopaedic Surgery, Kaiser Permanente South Bay Medical Center, Torrance, CA, USA Department of Orthopaedic Surgery, Harbor-UCLA Medical Center, Torrance, CA, USA c American Board of Orthopaedic Surgery, Hinsdale, IL, USA d Georgia Hand, Shoulder, and Elbow, Atlanta, GA, USA e Department of Orthopaedic Surgery, Kaiser Permanente Baldwin Park Medical Center, Baldwin Park, CA, USA b
Background: The purpose of this study was to analyze whether a recent trend in evidence supporting operative treatment of clavicular fractures is matched with an increase in operative fixation and complication rates in the United States. Methods: The American Board of Orthopaedic Surgery database was reviewed for cases with Current Procedural Terminology (American Medical Association, Chicago, IL, USA) code 23515 (clavicle open reduction internal fixation [ORIF]) from 1999 to 2010. The procedure rate for each year and the number of procedures for each candidate performing clavicle ORIF were calculated to determine if a change had occurred in the frequency of ORIF for clavicular fractures. Complication and outcome data were also reviewed. Results: In 2010 vs, 1999, there were statistically significant increases in the mean number of clavicle ORIF performed among all candidates (0.89 vs. 0.13; P < .0001) and in the mean number of clavicle ORIF per candidate performing clavicle ORIF (2.47 vs. 1.20, P < .0473). The difference in the percentage of part II candidates performing clavicle ORIF from the start to the end of the study (11% vs. 36%) was significant (P < .0001). There was a significant increase in the clavicle ORIF percentage of total cases (0.11% vs. 0.74%, P < .0001). The most common complication was hardware failure (4%). Conclusion: The rate of ORIF of clavicular fractures has increased in candidates taking part II of the American Board of Orthopaedic Surgery, with a low complication rate. The increase in operative fixation during this interval may have been influenced by literature suggesting improved outcomes in patients treated with operative stabilization of their clavicular fracture. Level of evidence: Epidemiology Study; Large Database Analysis © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved. Keywords: Clavicle; Fixation; Rate; Fracture; Shoulder; Complications; ABOS
Institutional Review Board approval was not required for this study. *Reprint requests: Ronald A. Navarro, MD, Department of Orthopaedic Surgery, Kaiser Permanente Baldwin Park Medical Center, 1011 Baldwin Park Blvd, Baldwin Park, CA 91706, USA. E-mail address: [email protected] (R.A. Navarro).
Clavicular fractures are common injuries that account for 2.6% of all fractures and represent 44% of fractures in the shoulder girdle.11 They are most common in young, active individuals who participate in activities or sports involving high-speed falls or violent collisions and are more fre-
1058-2746/$ - see front matter © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jse.2015.11.065
ARTICLE IN PRESS 2 quently found in the middle third of the clavicle.7 The fractured clavicle has traditionally been viewed as a nonoperative condition that can heal with a sling or a figure-of-8 swathe that pushes the shoulders apart. Two series in the 1960s combining 3000 patients largely reaffirmed the nonoperative nature of the fractured clavicle by demonstrating a nonunion rate of less than 1% with conservative treatment.10,14 More recently, however, published studies have begun to question whether all clavicular fractures are best treated conservatively. Hill et al3 found that a subset of adults with completely displaced middle-third clavicular fractures treated nonoperatively had a nonunion rate of 15%, considerably higher than previously reported. McKee et al8 studied 30 adults with displaced middle-third clavicular fractures who were treated nonoperatively and demonstrated significant strength deficits, especially endurance strength. A prospective, observational study of 868 patients with clavicular fractures revealed a nonunion rate of 4.5%. When a subgroup of displaced, comminuted midshaft fractures was analyzed, the rate of nonunion increased to 21%.13 More recent randomized controlled studies by Virtanen et al16 and Robinson et al12 have further confirmed increased nonunion rates with nonoperative treatment of displaced midshaft clavicular fractures. A recent meta-analysis of surgical fixation vs. nonoperative treatment of displaced midshaft clavicular fractures revealed nonunion rates of 2% with surgical fixation compared with 15% with conservative treatment.18 A multicenter prospective randomized controlled trial by the Canadian Orthopaedic Trauma Society comparing initial operative plate fixation vs. nonoperative treatment of displaced midshaft clavicular fractures revealed significantly improved Constant and Disabilities of Arm, Shoulder and Hand scores in the operatively treated group.2 Two nonunions occurred in the operative group compared with 7 nonunions (P = .042) and 9 symptomatic malunions in the nonoperative group. Furthermore, the patient satisfaction rate with the appearance of the shoulder was significantly higher after operative treatment. The purpose of this study was to analyze whether a recent trend in evidence supporting operative treatment of clavicular fractures is matched with an increase in operative fixation rates and reported complications.
Materials and methods The American Board of Orthopedic Surgery (ABOS) certification involves a 2-step process. Part I (written examination) is taken upon completion of an accredited orthopedic surgery residency. Candidates who have passed the written examination, have been in practice for 20 months, and have undergone peer review are allowed to sit for part II (oral examination) of board certification. Candidates submit a list of all surgical cases performed during a specified 6-month period to a Web-based database. Information collected includes date
R.A. Navarro et al. of the procedure, International Classification of Diseases, 9th Revision diagnosis codes, and Current Procedural Terminology (CPT; American Medical Association, Chicago, IL, USA) codes. The applicants also complete sections on each patient regarding outcomes of pain, function, deformity, complications, and patient satisfaction. This information is used to select 10 cases for each candidate to review during an oral examination. The ABOS database has been used for evaluating trends for various orthopedic procedures.1,4,9,17 The ABOS national database of cases submitted by part II candidates was reviewed for CPT code 23515–ORIF (open reduction internal fixation) clavicle from 1999 to 2010. From this group the number of clavicle ORIF cases performed each year was determined for 1999 to 2010. The procedure rate for each year was calculated. The total number of procedures and the number of procedures for each candidate performing clavicle ORIF were calculated. Using this information, we compared procedure rates for each year of a given time period to determine whether a significant increase occurred in the frequency of ORIF for clavicular fractures. In addition, the data submitted by the applicants were used to determine clavicle ORIF complications and early outcomes from this group.
Statistical methods An independent biostatistician performed the inferential statistical analysis. Parametric comparisons were conducted with use of unpaired 2-tailed t tests for 2-sample comparisons. Fisher exact tests were performed for contingency tables, and χ2 tests were performed for larger contingency tables. Statistical significance for all tests was selected at P < .05. Regression analysis was performed on the database where ABOS candidates performed at least 1 ORIF of the clavicle or code 23515 to assess for associations with year as a general trend. The years were also split variously to assess if certain years were the strongest predictor for change in trend.
Results During 1999 to 2010, candidates taking part II of the ABOS examination performed 2895 clavicle ORIF procedures. The patients who received ORIF of clavicle were an average age of 34 years, and 77% were male. The data from the ABOS part II candidates showed there was a statistically significant difference between the mean number of clavicle ORIF performed among all candidates in 2010 and 1999 (0.89 vs. 0.13, P < .0001). A significant difference occurred in the clavicle ORIF percentage of total cases between 2010 and 1999 (0.74% vs. 0.11%, P < .0001; Table I). A significant increase was also found between the percentage of part II candidates performing clavicle ORIF in 2010 and 1999 (36% vs. 11%, P < .0001). In addition, a significant difference was noted between the mean number of clavicle ORIF procedures performed by candidates with at least 1 clav-
ARTICLE IN PRESS Frequency and complications of clavicular fractures Table I Part II exam year
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
3
All candidates* Total candidates
Total cases
CPT 23515 cases
Cases/candidate
CPT 23515 cases/candidate
CPT 23515 cases/total cases
(No.)
(No.)
(No.)
Mean
SD
Mean
SD
(%)
648 709 725 706 613 698 687 655 662 664 663 680
76,030 89,009 91,267 91,190 77,444 91,382 88,205 86,854 87,253 88,021 85,557 81,675
83 116 103 114 140 158 172 186 322 408 489 604
117.3 125.5 125.9 129.2 126.3 130.9 128.4 132.6 131.8 132.6 129.0 120.1
58.3 58.7 59.5 60.9 62.5 62.1 65.9 69.5 69.7 67.3 65.4 64.2
0.1 0.2 0.1 0.2 0.2 0.2 0.3 0.3 0.5 0.6 0.7 0.9
0.4 0.5 0.5 0.5 0.6 0.7 0.6 0.8 1.2 1.2 1.4 1.9
0.1 0.1 0.1 0.1 0.2 0.2 0.2 0.2 0.4 0.5 0.6 0.7
CPT, Current Procedural Terminology (American Medical Association, Chicago, IL, USA); SD, standard deviation. * Year-by-year breakdown of all American Board of Orthopaedic Surgery part II candidates compared with those performing open reduction with internal fixation (ORIF) of the clavicle. There was a statistically significant difference between the mean number of clavicle ORIFs performed among all candidates in 2010 and 1999 (0.89 vs. 0.13; P < .0001).
icle ORIF in 2010 vs. 1999 (2.47 vs. 1.20, P < .0473). The percentage of total clavicle ORIF cases by candidates with at least 1 clavicle ORIF between 2010 and 1999 was significantly different (1.76% vs. 0.85%, P < .0001; Table II). The regression analysis revealed consistent trends in CPT 23515 cases/candidate (P < .0001) and CPT 23515 cases as a percentage of total cases (P = .0003), but not total cases/ candidate (P = .5609). The data were analyzed for a split before vs. after various years, comparing 1999 to 2002 vs. 2003 to 2010, then 1999 to 2003 vs. 2004 to 2010, all the way through 1999 to 2007 vs. 2008 to 2010. For both CPT 23515 cases/ Table II Part II exam year 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
candidate (R2 = 0.808, P < .0001) and CPT 23515 cases as a percentage of total cases (R2 = 0.750, P = .0003), the strongest increase was 1999 to 2006 vs. 2007 to 2010. Early outcomes reported pain was decreased or absent in 95%. Function was normal or improved in 88%. Deformity was normal or improved in 94%. Patient satisfaction was good or excellent in 90%. Complications reported were implant failure in 4%, infection in 2.3%, nonunion or delayed union in 1.9%, nerve palsy in 1.7%, and wound dehiscence in 1.4%. Fifteen patients returned to the operating room for intervention. However, we were unable to determine the exact reason
Candidates performing at least 1 case with Current Procedural Terminology code 23515* Total candidates
Total cases
CPT 23515 cases
Cases/candidate
CPT 23515 cases/candidate
CPT 23515 cases/total cases
(No.)
(No.)
(No.)
Mean
SD
Mean
SD
(%)
69 93 83 87 103 110 124 113 165 216 238 245
9814 12,952 12,734 13,699 15,251 17,199 18,790 18,442 27,121 32,335 35,748 34,289
83 116 103 114 140 158 172 186 322 408 489 604
142.2 139.3 153.4 157.5 148.1 156.4 151.5 163.2 164.4 149.7 150.2 140.0
57.6 53.9 58.9 55.5 70.1 64.3 62.4 75.1 73.8 65.1 66.4 62.6
1.2 1.2 1.2 1.3 1.4 1.4 1.4 1.6 2.0 1.9 2.1 2.5
0.5 0.5 0.7 0.7 0.7 1.0 0.7 1.2 1.6 1.3 1.7 2.6
0.8 0.9 0.8 0.8 0.9 0.9 0.9 1.0 1.2 1.3 1.4 1.8
CPT, Current Procedural Terminology (American Medical Association, Chicago, IL, USA); SD, standard deviation. * Year-by-year breakdown of all American Board of Orthopaedic Surgery (ABOS) candidates who performed at least 1 case with CPT 23515. There appears to be a steady increase from 2005 to 2010 resulting in a doubling of the percentage of total reported ABOS candidate cases represented by clavicle open reduction with internal fixation.
ARTICLE IN PRESS 4 due to limited reporting on ABOS. Implant fracture was reported in 13 patients, pneumonia in 6, and vascular injury in 3.
Discussion Clavicular fractures have long been viewed as a nonoperatively treated fracture. Earlier publications supported the efficacy of nonoperative treatment.10,14 However, more recent publications have questioned whether nonoperative treatment of midshaft, displaced clavicular fractures is equivalent to operative fixation.3,8,12,13,16,18 These reports support early fixation of displaced clavicular fractures to prevent nonunion and improve function or patient satisfaction, or both, by reducing the rate of deformity. If the rate of nonunion or malunion is higher after nonoperative treatment of displaced midshaft clavicular fractures, then it may be in the best interest of the patient to perform ORIF early to decrease the risk of complications, allow an easier surgical reduction, and speed the recovery process. In 2007, the Canadian Orthopaedic Trauma Society published their results from a multicenter randomized controlled trial demonstrating improved patient outcome measures with early primary ORIF of displaced clavicular fractures.2 The nonunion rate was decreased in the operative group vs. the nonoperative group, and 9 patients with symptomatic malunions were treated with a sling. Patients who underwent surgical fixation had earlier return to normal function. These authors attribute the contrasting evidence by era to changes in operative technique and perioperative care as well as newer implants. Several recent studies have used and published ABOS part II data as a means to assess trends and patterns in orthopedic surgery.1,4,5,17 The ABOS data from 1999 to 2010 in this study appear to show that the rate of open fixation treatment for clavicular fractures has increased since 1999. The mean number of clavicle ORIFs per candidate increased (2.47 vs. 1.20, P < .0473), and the percentage of part II candidates performing clavicle ORIF increased from the beginning period in 1999 to 2010 (11% vs. 36%). This increase amounts to approximately 1 operative case per year per candidate. However, this study confirms the increase in clavicle fixation during the period evaluated. The change in the practice pattern for increasing fixation of displaced clavicular fractures may have been influenced by published studies in 2005 to 2007.3,8,13,18 These studies demonstrated improved outcomes in patients treated with operative stabilization of displaced clavicular fractures compared with nonoperative management. Interestingly, the regression analysis performed in the current study revealed that the strongest predictor of association with increasing frequency of clavicle ORIF was the 1999 to 2006 vs. 2007 to 2010 year split. Although challenging to prove, this analysis may support the role that published studies may have in influencing practice patterns.
R.A. Navarro et al. The overall complication rate found in this database was low compared with other published studies. The nonunion or delayed union rate was 1.9%. According to a meta-analysis by Zlowodzki et al,18 nonrandomized, noncomparative pooled data across all studies showed that plating resulted in a nonunion rate of 2.5%, which was significantly lower compared with 5.9% for nonoperative treatment. The group then separately evaluated displaced clavicular fractures and found a significant nonunion rate of 15.1% in the nonoperative group. A recent, randomized controlled trial by Robinson et al12 of operative vs. nonoperative management of displaced clavicle fractures reported a 26% nonunion rate for the nonoperative group. Although studies have demonstrated decreased nonunion rates and improved outcomes with surgical fixation of displaced clavicular fractures, ORIF of the clavicle has its own associated complications. In a more recent study by the Canadian Orthopaedic Trauma Society,2 37% of operative patients experienced complications. The most common were transient brachial plexus symptoms (13%), hardware irritation requiring removal (8%), and wound infection or dehiscence, or both (4%). The nonoperative group had a similar rate of transient brachial plexus symptoms at 14%. A recent study by Leroux et al6 reported a reoperation rate of 24.6% after clavicle ORIF, with hardware removal being the most common reason for a secondary procedure. Robinson et al,12 reported 10 of 86 patients treated with clavicle plates required implant removal. The most common complication in our ABOS study was implant failure (4%), which is lower than reported by others. Improvements in precontoured plates have decreased hardware-related problems associated with ORIF of clavicular fractures.15 In our group of ABOS-reported patients, pain was decreased or absent in 95% of patients. The Canadian trauma group study reported 85% of operated-on patients were satisfied and without sensitivity or painful fracture sites. According to the surgeons reporting in our ABOS study, deformity was improved or eliminated in 94%. Because it is not stated on the applicant form specifically, this could have been radiographic or gross appearance. In the ABOS database, patient satisfaction was good or excellent in 90%. Limitations of our study include the question of whether the ABOS part II cohort is truly the best proxy for a national rate. Part II candidates may be more “conservative” than their board-certified counterparts and may have less technical experience. This method may thus have underestimated the national rate of ORIF of displaced clavicular fractures. Furthermore, our ABOS cohort represents patients operatedon during a 6-month period with short-term follow-up, which may underestimate the complication rates and ultimate outcomes. Longer follow-up could theoretically result in more implant-related issues and reoperation rates. Another study limitation is that all outcome measures (pain, function, deformity, and patient satisfaction) are reported by surgeons. This has its inherent bias and may not fully represent patient outcomes. In addition, evaluation of a
ARTICLE IN PRESS Frequency and complications of clavicular fractures retrospective database with input provided by various surgeons with different surgical techniques and equipment also has its limitations.
Conclusions Data from the ABOS show that the rate of open treatment for clavicular fractures has increased dramatically since 1999. This change in practice specific to ORIF of displaced clavicular fractures may have been influenced by clinical trials suggesting superior outcomes in patients treated with operative stabilization. The ABOS national dataset revealed a detailed but low rate of complications after clavicle ORIF at short-term follow-up.
Disclaimer Acumed Inc provided research support directly to the American Board of Orthopaedic Surgery (ABOS) to support the Principal Investigator’s (Ronald A. Navarro) acquisition of data that served as the basis for this study. The authors, their immediate families, and any research foundation with which they are affiliated did not receive any financial payments or other benefits from any commercial entity related to the subject of this article.
References 1. Anglen JO, Weinstein JN. Nail or plate fixation of intertrochanteric hip fractures: changing pattern of practice. A review of the American Board of Orthopaedic Surgery Database. J Bone Joint Surg Am 2008;90:700-7. http://dx.doi.org/10.2106/JBJS.G.00517 2. Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am 2007;89:110. http://dx.doi.org/10.2106/JBJS.F.00020 3. Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br 1997;79:537-9. 4. Koval KJ, Harrast JJ, Anglen JO, Weinstein JN. Fractures of the distal part of the radius. The evolution of practice over time. Where’s the evidence? J Bone Joint Surg Am 2008;90:1855-61. http://dx.doi.org/ 10.2106/JBJS.G.01569
5 5. Koval KJ, Marsh L, Anglen J, Weinstein J, Harrast JJ. Are recent graduates of orthopaedic training programs performing less fracture care? American Board of Orthopedic Surgeons part II: a quality improvement initiative. J Orthop Trauma 2012;26:189-92. http://dx.doi.org/10.1097/ BOT.0b013e31822c846e 6. Leroux T, Wasserstein D, Henry P, Khoshbin A, Ogilvie-Harris D, Mahomed N, et al. Rate of and risk factors for reoperations after open reduction and internal fixation of midshaft clavicle fractures: a population-based study in Ontario, Canada. J Bone Joint Surg Am 2014;96:1119-25. http://dx.doi.org/10.2106/JBJS.M.00607 7. McKee M. Fractures of the clavicle. In: Bucholz RW, Heckman JD, Court-Brown CM, Tornetta P 3rd, editors. Rockwood and Green’s fractures in adults. 7th edition. Philadelphia: Lippincott Williams and Wilkins; 2010. p. 1106-43. 8. McKee MD, Pedersen EM, Jones C, Stephen DJG, Kreder HJ, Schemitsch EH, et al. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am 2006;88:35-40. http://dx.doi.org/10.2106/JBJS.D.02795 9. Musahl V, Jordan SS, Colvin AC, Tranovich MJ, Irrgang JJ, Harner CD. Practice patterns for combined anterior cruciate ligament and meniscal surgery in the United States. Am J Sports Med 2010;38:918-23. http://dx.doi.org/10.1177/0363546509357900 10. Neer CS. Nonunion of the clavicle. J Am Med Assoc 1960;172:1006-11. 11. Postacchini F, Gumina S, De Santis P, Albo F. Epidemiology of clavicle fractures. J Shoulder Elbow Surg 2002;11:452-6. http://dx.doi.org/ 10.1067/mse.2002.126613 12. Robinson C, Goudie EB, Murray IR, Jenkins PJ, Ahktar MA, Read EO, 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. http://dx.doi.org/10.2106/JBJS.L.00307 13. Robinson CM, Court-Brown CM, McQueen MM, Wakefield AE. Estimating the risk of nonunion following nonoperative treatment of a clavicular fracture. J Bone Joint Surg Am 2004;86-A:1359-65. 14. Rowe C. An atlas of anatomy and treatment of midclavicular fractures. Clin Orthop Relat Res 1968;58:29-42. 15. Vanbeek C, Boselli KJ, Cadet ER, Ahmad CS, Levine WN. Precontoured plating of clavicle fractures: decreased hardware-related complications? Clin Orthop Relat Res 2011;469:3337-43. http://dx.doi.org/10.1007/ s11999-011-1868-0 16. Virtanen KJ, Remes V, Pajarinen J, Savolainen V, Björkenheim J-V, Paavola M. Sling compared with plate osteosynthesis for treatment of displaced midshaft clavicular fractures: a randomized clinical trial. J Bone Joint Surg Am 2012;94:1546-53. http://dx.doi.org/10.2106/JBJS.J.01999 17. Vogel LA, Moen TC, Macaulay AA, Arons RR, Cadet ER, Ahmad CS, et al. Superior labrum anterior-to-posterior repair incidence: a longitudinal investigation of community and academic databases. J Shoulder Elbow Surg 2014;23:e119-26. http://dx.doi.org/10.1016/j.jse.2013.11.002 18. Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma 2005;19:504-7. http://dx.doi.org/10.1097/01.bot.0000172287.44278.ef
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Frequency and complications after operative fixation of clavicular fractures Ronald A. Navarro, MDa,*, Jonathan D. Gelber, MDb, John J. Harrast, MSc, John G. Seiler III, MDd, Kent R. Jackson, MDa, Ivan A. Garcia, MDe a
Department of Orthopaedic Surgery, Kaiser Permanente South Bay Medical Center, Torrance, CA, USA Department of Orthopaedic Surgery, Harbor-UCLA Medical Center, Torrance, CA, USA c American Board of Orthopaedic Surgery, Hinsdale, IL, USA d Georgia Hand, Shoulder, and Elbow, Atlanta, GA, USA e Department of Orthopaedic Surgery, Kaiser Permanente Baldwin Park Medical Center, Baldwin Park, CA, USA b
Background: The purpose of this study was to analyze whether a recent trend in evidence supporting operative treatment of clavicular fractures is matched with an increase in operative fixation and complication rates in the United States. Methods: The American Board of Orthopaedic Surgery database was reviewed for cases with Current Procedural Terminology (American Medical Association, Chicago, IL, USA) code 23515 (clavicle open reduction internal fixation [ORIF]) from 1999 to 2010. The procedure rate for each year and the number of procedures for each candidate performing clavicle ORIF were calculated to determine if a change had occurred in the frequency of ORIF for clavicular fractures. Complication and outcome data were also reviewed. Results: In 2010 vs, 1999, there were statistically significant increases in the mean number of clavicle ORIF performed among all candidates (0.89 vs. 0.13; P < .0001) and in the mean number of clavicle ORIF per candidate performing clavicle ORIF (2.47 vs. 1.20, P < .0473). The difference in the percentage of part II candidates performing clavicle ORIF from the start to the end of the study (11% vs. 36%) was significant (P < .0001). There was a significant increase in the clavicle ORIF percentage of total cases (0.11% vs. 0.74%, P < .0001). The most common complication was hardware failure (4%). Conclusion: The rate of ORIF of clavicular fractures has increased in candidates taking part II of the American Board of Orthopaedic Surgery, with a low complication rate. The increase in operative fixation during this interval may have been influenced by literature suggesting improved outcomes in patients treated with operative stabilization of their clavicular fracture. Level of evidence: Epidemiology Study; Large Database Analysis © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved. Keywords: Clavicle; Fixation; Rate; Fracture; Shoulder; Complications; ABOS
Institutional Review Board approval was not required for this study. *Reprint requests: Ronald A. Navarro, MD, Department of Orthopaedic Surgery, Kaiser Permanente Baldwin Park Medical Center, 1011 Baldwin Park Blvd, Baldwin Park, CA 91706, USA. E-mail address: [email protected] (R.A. Navarro).
Clavicular fractures are common injuries that account for 2.6% of all fractures and represent 44% of fractures in the shoulder girdle.11 They are most common in young, active individuals who participate in activities or sports involving high-speed falls or violent collisions and are more fre-
1058-2746/$ - see front matter © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jse.2015.11.065
ARTICLE IN PRESS 2 quently found in the middle third of the clavicle.7 The fractured clavicle has traditionally been viewed as a nonoperative condition that can heal with a sling or a figure-of-8 swathe that pushes the shoulders apart. Two series in the 1960s combining 3000 patients largely reaffirmed the nonoperative nature of the fractured clavicle by demonstrating a nonunion rate of less than 1% with conservative treatment.10,14 More recently, however, published studies have begun to question whether all clavicular fractures are best treated conservatively. Hill et al3 found that a subset of adults with completely displaced middle-third clavicular fractures treated nonoperatively had a nonunion rate of 15%, considerably higher than previously reported. McKee et al8 studied 30 adults with displaced middle-third clavicular fractures who were treated nonoperatively and demonstrated significant strength deficits, especially endurance strength. A prospective, observational study of 868 patients with clavicular fractures revealed a nonunion rate of 4.5%. When a subgroup of displaced, comminuted midshaft fractures was analyzed, the rate of nonunion increased to 21%.13 More recent randomized controlled studies by Virtanen et al16 and Robinson et al12 have further confirmed increased nonunion rates with nonoperative treatment of displaced midshaft clavicular fractures. A recent meta-analysis of surgical fixation vs. nonoperative treatment of displaced midshaft clavicular fractures revealed nonunion rates of 2% with surgical fixation compared with 15% with conservative treatment.18 A multicenter prospective randomized controlled trial by the Canadian Orthopaedic Trauma Society comparing initial operative plate fixation vs. nonoperative treatment of displaced midshaft clavicular fractures revealed significantly improved Constant and Disabilities of Arm, Shoulder and Hand scores in the operatively treated group.2 Two nonunions occurred in the operative group compared with 7 nonunions (P = .042) and 9 symptomatic malunions in the nonoperative group. Furthermore, the patient satisfaction rate with the appearance of the shoulder was significantly higher after operative treatment. The purpose of this study was to analyze whether a recent trend in evidence supporting operative treatment of clavicular fractures is matched with an increase in operative fixation rates and reported complications.
Materials and methods The American Board of Orthopedic Surgery (ABOS) certification involves a 2-step process. Part I (written examination) is taken upon completion of an accredited orthopedic surgery residency. Candidates who have passed the written examination, have been in practice for 20 months, and have undergone peer review are allowed to sit for part II (oral examination) of board certification. Candidates submit a list of all surgical cases performed during a specified 6-month period to a Web-based database. Information collected includes date
R.A. Navarro et al. of the procedure, International Classification of Diseases, 9th Revision diagnosis codes, and Current Procedural Terminology (CPT; American Medical Association, Chicago, IL, USA) codes. The applicants also complete sections on each patient regarding outcomes of pain, function, deformity, complications, and patient satisfaction. This information is used to select 10 cases for each candidate to review during an oral examination. The ABOS database has been used for evaluating trends for various orthopedic procedures.1,4,9,17 The ABOS national database of cases submitted by part II candidates was reviewed for CPT code 23515–ORIF (open reduction internal fixation) clavicle from 1999 to 2010. From this group the number of clavicle ORIF cases performed each year was determined for 1999 to 2010. The procedure rate for each year was calculated. The total number of procedures and the number of procedures for each candidate performing clavicle ORIF were calculated. Using this information, we compared procedure rates for each year of a given time period to determine whether a significant increase occurred in the frequency of ORIF for clavicular fractures. In addition, the data submitted by the applicants were used to determine clavicle ORIF complications and early outcomes from this group.
Statistical methods An independent biostatistician performed the inferential statistical analysis. Parametric comparisons were conducted with use of unpaired 2-tailed t tests for 2-sample comparisons. Fisher exact tests were performed for contingency tables, and χ2 tests were performed for larger contingency tables. Statistical significance for all tests was selected at P < .05. Regression analysis was performed on the database where ABOS candidates performed at least 1 ORIF of the clavicle or code 23515 to assess for associations with year as a general trend. The years were also split variously to assess if certain years were the strongest predictor for change in trend.
Results During 1999 to 2010, candidates taking part II of the ABOS examination performed 2895 clavicle ORIF procedures. The patients who received ORIF of clavicle were an average age of 34 years, and 77% were male. The data from the ABOS part II candidates showed there was a statistically significant difference between the mean number of clavicle ORIF performed among all candidates in 2010 and 1999 (0.89 vs. 0.13, P < .0001). A significant difference occurred in the clavicle ORIF percentage of total cases between 2010 and 1999 (0.74% vs. 0.11%, P < .0001; Table I). A significant increase was also found between the percentage of part II candidates performing clavicle ORIF in 2010 and 1999 (36% vs. 11%, P < .0001). In addition, a significant difference was noted between the mean number of clavicle ORIF procedures performed by candidates with at least 1 clav-
ARTICLE IN PRESS Frequency and complications of clavicular fractures Table I Part II exam year
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
3
All candidates* Total candidates
Total cases
CPT 23515 cases
Cases/candidate
CPT 23515 cases/candidate
CPT 23515 cases/total cases
(No.)
(No.)
(No.)
Mean
SD
Mean
SD
(%)
648 709 725 706 613 698 687 655 662 664 663 680
76,030 89,009 91,267 91,190 77,444 91,382 88,205 86,854 87,253 88,021 85,557 81,675
83 116 103 114 140 158 172 186 322 408 489 604
117.3 125.5 125.9 129.2 126.3 130.9 128.4 132.6 131.8 132.6 129.0 120.1
58.3 58.7 59.5 60.9 62.5 62.1 65.9 69.5 69.7 67.3 65.4 64.2
0.1 0.2 0.1 0.2 0.2 0.2 0.3 0.3 0.5 0.6 0.7 0.9
0.4 0.5 0.5 0.5 0.6 0.7 0.6 0.8 1.2 1.2 1.4 1.9
0.1 0.1 0.1 0.1 0.2 0.2 0.2 0.2 0.4 0.5 0.6 0.7
CPT, Current Procedural Terminology (American Medical Association, Chicago, IL, USA); SD, standard deviation. * Year-by-year breakdown of all American Board of Orthopaedic Surgery part II candidates compared with those performing open reduction with internal fixation (ORIF) of the clavicle. There was a statistically significant difference between the mean number of clavicle ORIFs performed among all candidates in 2010 and 1999 (0.89 vs. 0.13; P < .0001).
icle ORIF in 2010 vs. 1999 (2.47 vs. 1.20, P < .0473). The percentage of total clavicle ORIF cases by candidates with at least 1 clavicle ORIF between 2010 and 1999 was significantly different (1.76% vs. 0.85%, P < .0001; Table II). The regression analysis revealed consistent trends in CPT 23515 cases/candidate (P < .0001) and CPT 23515 cases as a percentage of total cases (P = .0003), but not total cases/ candidate (P = .5609). The data were analyzed for a split before vs. after various years, comparing 1999 to 2002 vs. 2003 to 2010, then 1999 to 2003 vs. 2004 to 2010, all the way through 1999 to 2007 vs. 2008 to 2010. For both CPT 23515 cases/ Table II Part II exam year 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
candidate (R2 = 0.808, P < .0001) and CPT 23515 cases as a percentage of total cases (R2 = 0.750, P = .0003), the strongest increase was 1999 to 2006 vs. 2007 to 2010. Early outcomes reported pain was decreased or absent in 95%. Function was normal or improved in 88%. Deformity was normal or improved in 94%. Patient satisfaction was good or excellent in 90%. Complications reported were implant failure in 4%, infection in 2.3%, nonunion or delayed union in 1.9%, nerve palsy in 1.7%, and wound dehiscence in 1.4%. Fifteen patients returned to the operating room for intervention. However, we were unable to determine the exact reason
Candidates performing at least 1 case with Current Procedural Terminology code 23515* Total candidates
Total cases
CPT 23515 cases
Cases/candidate
CPT 23515 cases/candidate
CPT 23515 cases/total cases
(No.)
(No.)
(No.)
Mean
SD
Mean
SD
(%)
69 93 83 87 103 110 124 113 165 216 238 245
9814 12,952 12,734 13,699 15,251 17,199 18,790 18,442 27,121 32,335 35,748 34,289
83 116 103 114 140 158 172 186 322 408 489 604
142.2 139.3 153.4 157.5 148.1 156.4 151.5 163.2 164.4 149.7 150.2 140.0
57.6 53.9 58.9 55.5 70.1 64.3 62.4 75.1 73.8 65.1 66.4 62.6
1.2 1.2 1.2 1.3 1.4 1.4 1.4 1.6 2.0 1.9 2.1 2.5
0.5 0.5 0.7 0.7 0.7 1.0 0.7 1.2 1.6 1.3 1.7 2.6
0.8 0.9 0.8 0.8 0.9 0.9 0.9 1.0 1.2 1.3 1.4 1.8
CPT, Current Procedural Terminology (American Medical Association, Chicago, IL, USA); SD, standard deviation. * Year-by-year breakdown of all American Board of Orthopaedic Surgery (ABOS) candidates who performed at least 1 case with CPT 23515. There appears to be a steady increase from 2005 to 2010 resulting in a doubling of the percentage of total reported ABOS candidate cases represented by clavicle open reduction with internal fixation.
ARTICLE IN PRESS 4 due to limited reporting on ABOS. Implant fracture was reported in 13 patients, pneumonia in 6, and vascular injury in 3.
Discussion Clavicular fractures have long been viewed as a nonoperatively treated fracture. Earlier publications supported the efficacy of nonoperative treatment.10,14 However, more recent publications have questioned whether nonoperative treatment of midshaft, displaced clavicular fractures is equivalent to operative fixation.3,8,12,13,16,18 These reports support early fixation of displaced clavicular fractures to prevent nonunion and improve function or patient satisfaction, or both, by reducing the rate of deformity. If the rate of nonunion or malunion is higher after nonoperative treatment of displaced midshaft clavicular fractures, then it may be in the best interest of the patient to perform ORIF early to decrease the risk of complications, allow an easier surgical reduction, and speed the recovery process. In 2007, the Canadian Orthopaedic Trauma Society published their results from a multicenter randomized controlled trial demonstrating improved patient outcome measures with early primary ORIF of displaced clavicular fractures.2 The nonunion rate was decreased in the operative group vs. the nonoperative group, and 9 patients with symptomatic malunions were treated with a sling. Patients who underwent surgical fixation had earlier return to normal function. These authors attribute the contrasting evidence by era to changes in operative technique and perioperative care as well as newer implants. Several recent studies have used and published ABOS part II data as a means to assess trends and patterns in orthopedic surgery.1,4,5,17 The ABOS data from 1999 to 2010 in this study appear to show that the rate of open fixation treatment for clavicular fractures has increased since 1999. The mean number of clavicle ORIFs per candidate increased (2.47 vs. 1.20, P < .0473), and the percentage of part II candidates performing clavicle ORIF increased from the beginning period in 1999 to 2010 (11% vs. 36%). This increase amounts to approximately 1 operative case per year per candidate. However, this study confirms the increase in clavicle fixation during the period evaluated. The change in the practice pattern for increasing fixation of displaced clavicular fractures may have been influenced by published studies in 2005 to 2007.3,8,13,18 These studies demonstrated improved outcomes in patients treated with operative stabilization of displaced clavicular fractures compared with nonoperative management. Interestingly, the regression analysis performed in the current study revealed that the strongest predictor of association with increasing frequency of clavicle ORIF was the 1999 to 2006 vs. 2007 to 2010 year split. Although challenging to prove, this analysis may support the role that published studies may have in influencing practice patterns.
R.A. Navarro et al. The overall complication rate found in this database was low compared with other published studies. The nonunion or delayed union rate was 1.9%. According to a meta-analysis by Zlowodzki et al,18 nonrandomized, noncomparative pooled data across all studies showed that plating resulted in a nonunion rate of 2.5%, which was significantly lower compared with 5.9% for nonoperative treatment. The group then separately evaluated displaced clavicular fractures and found a significant nonunion rate of 15.1% in the nonoperative group. A recent, randomized controlled trial by Robinson et al12 of operative vs. nonoperative management of displaced clavicle fractures reported a 26% nonunion rate for the nonoperative group. Although studies have demonstrated decreased nonunion rates and improved outcomes with surgical fixation of displaced clavicular fractures, ORIF of the clavicle has its own associated complications. In a more recent study by the Canadian Orthopaedic Trauma Society,2 37% of operative patients experienced complications. The most common were transient brachial plexus symptoms (13%), hardware irritation requiring removal (8%), and wound infection or dehiscence, or both (4%). The nonoperative group had a similar rate of transient brachial plexus symptoms at 14%. A recent study by Leroux et al6 reported a reoperation rate of 24.6% after clavicle ORIF, with hardware removal being the most common reason for a secondary procedure. Robinson et al,12 reported 10 of 86 patients treated with clavicle plates required implant removal. The most common complication in our ABOS study was implant failure (4%), which is lower than reported by others. Improvements in precontoured plates have decreased hardware-related problems associated with ORIF of clavicular fractures.15 In our group of ABOS-reported patients, pain was decreased or absent in 95% of patients. The Canadian trauma group study reported 85% of operated-on patients were satisfied and without sensitivity or painful fracture sites. According to the surgeons reporting in our ABOS study, deformity was improved or eliminated in 94%. Because it is not stated on the applicant form specifically, this could have been radiographic or gross appearance. In the ABOS database, patient satisfaction was good or excellent in 90%. Limitations of our study include the question of whether the ABOS part II cohort is truly the best proxy for a national rate. Part II candidates may be more “conservative” than their board-certified counterparts and may have less technical experience. This method may thus have underestimated the national rate of ORIF of displaced clavicular fractures. Furthermore, our ABOS cohort represents patients operatedon during a 6-month period with short-term follow-up, which may underestimate the complication rates and ultimate outcomes. Longer follow-up could theoretically result in more implant-related issues and reoperation rates. Another study limitation is that all outcome measures (pain, function, deformity, and patient satisfaction) are reported by surgeons. This has its inherent bias and may not fully represent patient outcomes. In addition, evaluation of a
ARTICLE IN PRESS Frequency and complications of clavicular fractures retrospective database with input provided by various surgeons with different surgical techniques and equipment also has its limitations.
Conclusions Data from the ABOS show that the rate of open treatment for clavicular fractures has increased dramatically since 1999. This change in practice specific to ORIF of displaced clavicular fractures may have been influenced by clinical trials suggesting superior outcomes in patients treated with operative stabilization. The ABOS national dataset revealed a detailed but low rate of complications after clavicle ORIF at short-term follow-up.
Disclaimer Acumed Inc provided research support directly to the American Board of Orthopaedic Surgery (ABOS) to support the Principal Investigator’s (Ronald A. Navarro) acquisition of data that served as the basis for this study. The authors, their immediate families, and any research foundation with which they are affiliated did not receive any financial payments or other benefits from any commercial entity related to the subject of this article.
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