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Surgical treatment of displaced midshaft clavicular fractures with precontoured plates
J Shoulder Elbow Surg (2015) 24, 1036-1040
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Surgical treatment of displaced midshaft clavicular fractures with precontoured plates Maximiliano Ranalletta, MD, Luciano A. Rossi, MD*, Santiago L. Bongiovanni, MD, Ignacio Tanoira, MD, Nicolas S. Piuzzi, MD, Gaston Maignon, MD Department of Orthopedics and Traumatology, Prof. Dr. Carlos E. Ottolenghi, Italian Hospital of Buenos Aires, Buenos Aires, Argentina Background: Plate fixation of displaced midshaft clavicular fractures has been shown to decrease nonunion, symptomatic malunion, and residual shoulder disability compared with nonoperative treatment. However hardware-related complications are a problem. The new features of the precontoured locking plates may reduce the need for hardware removal, thus maintaining the advantages of plate fixation. This study evaluated the clinical outcomes of patients with displaced midshaft clavicular fractures treated with precontoured locking plates. Materials and methods: From November 2008 to December 2012, we surgically treated 72 patients with displaced midshaft clavicular fractures. We retrospectively evaluated 68 patients who underwent 68 interventions. Postoperative functional outcomes were assessed with the Constant score, the 11-item version of the Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire, and radiographs. Pain was subjectively assessed with a visual analog scale. Complications were recorded. Patients were asked if they were able to return to their previous employment level. Results: The mean follow-up period was 23.6 10.7 months. The average values of the Constant, QuickDASH, and visual analog scale scores were 97.8, 1.8, and 0.4 points, respectively. At the last follow-up, 98.5% were able to return to their regular work. Of 15 complications (22.1%) that occurred, only 3 were considered as major: 1 subclavian vein extrinsic compression, 1 nonunion, and 1 hardware loosening. Hardware removal was required in 9 patients (13.2%). Conclusions: Satisfactory clinical results with a low rate of complications were achieved with precontoured locking plates for displaced midshaft clavicular fractures and a low rate of hardware removal compared with traditional plates. Level of evidence: Level IV, Case Series, Treatment Study. Ó 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Clavicular fracture; midshaft; precontoured; plates
This study was approved by the Ethics Committee of the Italian Hospital of Buenos Aires (IRB: 00003580, Study No.: 2320). *Reprint requests: Luciano A. Rossi, MD, Rawson 280, Appt 8A, Buenos Aires 1183, Argentina. E-mail address: [email protected] (L.A. Rossi).
Clavicular fractures are common injuries and account for approximately 2.6% to 5% of all fractures in adults. Middle-third fractures are the most common type, representing approximately 80% of all clavicular fractures, of which 48% are displaced and 19% are comminuted.25,26
1058-2746/$ - see front matter Ó 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. http://dx.doi.org/10.1016/j.jse.2014.12.013
Precontoured plates for displaced clavicular fractures
1037
Figure 1 A 45 up-tilted clavicle radiograph shows (A) a Robinson type 2B2 fracture (displaced, comminuted, and segmental) and (B) bony union and that the precontoured plate fits the anatomic shape of the biological clavicle.
Traditionally, nonsurgical management has been favored as the initial treatment for most clavicular fractures because the initial studies did not separate displaced and comminuted fractures from the whole.24,28 More recently, however, several studies showed suboptimal outcomes with nonoperative treatment in this subgroup of fractures.2,3,6,12 Hill et al14 reported a 15% incidence of nonunion and a 31% rate of unsatisfactory results in 52 patients with completely displaced midshaft clavicular fractures treated nonoperatively. Similar unfavorable outcomes with nonoperative treatment for displaced clavicular fractures were later updated by various studies.20,21,24,25 Several recent prospective, randomized clinical trials comparing nonoperative treatment with plate fixation showed that operative treatment improved functional outcomes and significantly decreased the incidence of longterm complications, such as nonunion and symptomatic malunion.3,23,27,29 However, several problems associated with plate fixation have been reported, including hardwarerelated complications, such as irritation, protrusion, or loosening, and wound complications (infection, dehiscence).17 The development of precontoured clavicle plates and the introduction of angular stability have paved the way for a new perspective on surgical treatment for theses fractures. The aim of this study was to analyze the clinical outcomes and hardware-related complications of a group of patients with displaced midshaft clavicular fractures treated using precontoured locking plates.
Materials and methods Seventy-two patients with 72 midshaft clavicular fractures (Fig. 1, A) were surgically treated at our unit with open reduction and precontoured angular stability plate fixation. Inclusion criteria were (a) patients aged between 16 and 70 years, (b) type 2B fractures according to Robinson’s classification,27 and (c) displacement (more than 2 cm). Exclusion criteria were (a) open fracture, (b) neurovascular injury, (c) a concomitant upper extremity injury, (d) pathologic fracture, (e) previous fracture in the same shoulder, and (f) lack of informed consent. The analysis consisted of 68 fractures in 68 patients because 4 patients were lost to follow-up.
Demographic and fracture characteristics were documented Patients were seen postoperatively at 1 week, 2 weeks, and monthly until fracture consolidation, and then once a year. Radiologic evaluation was obtained in the immediate postoperative day and monthly until fracture consolidation. Fracture consolidation was defined as complete periosteal and endosteal bridging visible between the medial and lateral fragments in at least 2 different radiographic views and the absence of pain and instability in the fracture region. Patients were evaluated at the last follow-up, by one of the authors (L.A.R.), using the Constant score and the 11-item version of the Disabilities of Arm, Shoulder and Hand (QuickDASH) score. Residual pain was evaluated using a visual analog scale (VAS), with 0 being ‘‘no pain’’ and 10 being ‘‘maximum pain.’’ All surgery-related complications and reoperations were documented. Patients were also asked if they had been able to practice sports again and if they had been able to perform them at the same level they had before the accident. Lastly, patients were asked if they were able to return to their previous work (Table I) Patients received combined anesthesia (regional blockade and general anesthesia) and were placed in the beach chair position with an enhancement behind the ipsilateral scapula. An anteriorinferior approach centered in the fracture site was used. Once anatomic fracture reduction was performed, we proceeded with fixation. A precontoured locking plate (Acumed, Hillsboro, OR, USA) was placed on the superior side of the clavicle (Fig. 1, B). Interfragmentary screws were used for fragment fixation when a third fragment was present. In each plate fixation, we used a minimum of 3 screws on each side of the fracture. The postoperative rehabilitation protocol consisted of an arm sling during the first 2 postoperative weeks. Pendulum motion was permitted during the first 3 weeks, followed by active abduction and flexion up to the horizontal plane from 3 to 6 weeks. Full shoulder active range of motion was allowed after 6 weeks, and return to full activities was permitted after 3 months.
Statistical methodology Continuous variables are presented as means standard deviations and categoric variables as absolute and relative frequencies. The statistical analysis was performed using STATA 12 software (StataCorp LP, College Station, TX, USA). A P value of <.05 was considered statistically significant.
1038 Table I
M. Ranalletta et al. Demographic and fracture-related characteristics
Variables Gender Male Female Age, y Dominant arm No Yes Robinson classification Subtype B1 Subtype B2 Mechanism of injury Sports Motorcycle Fall Car accident Bicycle Others
No. (%) or mean SD
Table II Summary of functional outcomes according to the Robinson classification Scores
54 (79.4) 14 (20.6) 33.1 11.9 30 (44.1) 38 (55.9) 49 (72) 19 (28) 27 18 9 7 5 2
(39.7) (26.5) (13.2) (10.3) (7.4) (2.9)
SD, standard deviation.
Results The series consisted of 54 men (79.4%) and 14 women (20.6%) with an average age of 33.1 11.9 years who presented with 37 fractures on the left side and 31 on the right side; 38 fractures (55.9%) were on the dominant side. All fractures were classified as group 2B according to the Robinson classification; specifically, 49 subtype B1 and 19 subtype B2 fractures were identified. The main cause of fracture was sport-related trauma, present in 27 patients (39.7%); with motorcycle-related accidents being the second most common reason, in 18 patients (26.5%; Table I). The average time to surgery was 9.3 6.0 days (range, 220 days). Average surgery time was 77 minutes (range, 40125 minutes). There were no major intraoperative complications. Average follow-up was 23.6 10.7 months (range, 1249 months). Sixty-seven fractures (98.5%) consolidated. The average Constant score was 97.8 6.4 points (range, 56-100 points). The average QuickDASH score was 1.8 4.8 points (range, 0-32 points). Pain during follow-up was at an average of 0.4 1.1 points (range, 0-6 points) according to the VAS. Considering the fracture type, according to the Robinson classification, there were no significant differences regarding functional outcomes (Table II). From the 61 patients who were active workers at the time of the accident, 60 (98.5%) were able to return to their previous working routine. Fifteen complications occurred in 14 patients (22.1%), and 3 of these complications (4.5%) were considered as major. The first consisted of a subclavian vein extrinsic compression by a long screw that protruded from the
Constant QuickDASH VAS
Subtype B1
Subtype B2
(Mean SD)
(Mean SD)
98.0 6.9 1.5 .4.8 0.3 0.9
97.2 5.0 2.6 4.8 0.6 1.3
P value* .661 .382 .232
QuickDASH, 11-item version of the Disabilities of Arm, Shoulder and Hand; SD, standard deviation; VAS, visual analog scale. ) P value derived from the Student t test.
Table III
Summary of complications Characteristic present)
No. (%)
Any complication Major complications Nonunion Hardware loosening Subclavian vein compression Minor complications Hardware removal Hypertrophic scar Superficial infection
15 3 1 1 1 12 9 2 1
)
(22.1) (4.5) (1.5) (1.5) (1.5) (17.6) (13.2) (2.9) (1.5)
The same patient can contribute to more than 1 category.
inferior side of the clavicle, requiring hardware removal. The second was an implant loosening. The patient was immobilized with a sling until fracture consolidation, and then the plate was removed. The third major complication was a nonunion. The implant was removed, the nonunion was decorticated, and a new reduction and osteosynthesis with a precontoured plate and addition of autologous iliac crest graft was performed. Twelve minor complications (17.6%) occurred (Table III). Plate removal was necessary after fracture consolidation in 9 patients (13.2%). Hardware was removed because of prominence and discomfort in 7 patients and pain in 2 patients. None of these patients had a refracture after 12 months from plate removal. The remaining 3 complications were 2 hypertrophic scars and 1 superficial wound infection that resolved with oral antibiotics. The reoperation rate was 16.1%. Excluding patients who underwent hardware removal, the overall revision rate was 2.9%.
Discussion Recent meta-analyses of randomized controlled trials comparing surgical vs nonoperative treatment of displaced clavicular fractures show greater prevalence of nonunion, symptomatic malunion, and poor functional outcomes after nonsurgical management.22,30,31 Despite the benefits of
Precontoured plates for displaced clavicular fractures Table IV Comparison of reported hardware removal rate for midshaft clavicular fractures treated with noncontoured and precontoured plates Study
Year
Type of plate
No.
Hardware removal rate, No. (%)
Kabak16 Chen6 Chandrasenan5
2004 2008 2008
VanBeek28
2011
Lai19 Campochiaro2 Our study
2012 2012 2014
Noncontoured Noncontoured Precontoured Noncontoured Precontoured Noncontoured Noncontoured Precontoured Precontoured
33 111 15 15 28 14 54 68 68
9/23 82/111 0/15 9/15 3/28 3/14 20/54 10/68 9/68
(39.1) (73.8) (0) (60) (10.7) (21.4) (37) (14.7) (13.2)
surgical treatment, the optimal implant for clavicular fixation remains controversial. Favorable outcomes were reported with plates,3,23,29 but there have been numerous related problems with these implants. The most frequently reported have been hardware irritation, protrusion, or loosening, and wound complications (infection, dehiscence).6,7,16,19 The aim of this retrospective study was to analyze the clinical outcome and complications of patients with displaced midshaft clavicular fractures treated using precontoured locking plates. The design features of precontoured plates may afford potential benefits. Firstly, they have the anatomic shape of the natural clavicle and a large modularity with available right and left clavicle fittings. This allows facing all types of midshaft fractures and may facilitate surgical technique. Secondly, the low profile and rounded edges could reduce the risk of postoperative hardware intolerance. Finally, the lower modulus of elasticity of titanium compared with stainless steel of other plates may lead to less stress shielding.13 Biomechanical and anatomical studies support the use of precontoured plates.4,5,9,13,15 However, evidence in the literature on clinical results with precontoured plates is still limited. Campochiaro et al2 retrospectively evaluated 68 of 89 patients treated with precontoured plates and showed excellent functional results, with only 14.3% plate removal after fracture consolidation. However, 24% of the patients were untraceable at follow-up, and lateral clavicular fractures were also included in the analysis. VanBeek et al28 retrospectively compared the outcomes of 24 patients treated with precontoured plates and 14 treated with noncontoured plates. Even though the study population size was limited, they showed higher hardware removal using noncontoured plates (21.4%) than using precontoured plates (10.7%). In our study, satisfactory clinical outcomes were obtained, similar to those reported previously with noncontoured plate fixation.3,23,27,29 Our overall complication rate was 22%, with a total reoperation rate of 16.1%.
1039 These results were consistent with previously published rates.1,3,5,23,29 Our hardware removal rate of 13.2% was lower than previously published rates of 28.6% to 76.7% with the use of noncontoured plates 6,7,16,19 (Table IV). The use of precontoured plates has not been the only attempt to decrease hardware discomfort. Anteriorinferior plating was described to address the issue of plate prominence.8,18 Formaini et al,10 showed, with similar time to radiographic union, that implant prominence was nearly double in patients with a retained superior plate compared with an anterior-inferior plate (54% vs 29%, respectively; P ¼ .04). Another described strategy has been the use of smaller plates. Galdi et al,11 found that compared with 3.5-mm anterior-inferior plating, 2.7-mm anterior-inferior plating for Arbeitsgemeinschaft fur Osteosynthesefragen/Orthopaedic Trauma Association type B clavicular fractures leads to significantly higher rates of cosmetic acceptability while reducing the need for a secondary procedure and achieving excellent clinical outcomes. Our study has several limitations. First, this was a retrospective study, and all data were collected from patient records. Second, there was no control group. Finally, all plates were placed superiorly on the clavicle; therefore, our findings cannot be generalized to plating of the clavicle in other locations.
Conclusions This study showed satisfactory clinical outcomes and a low complication rate in patients with displaced midshaft clavicular fractures treated using precontoured locking plates. The hardware removal rate was lower than rates reported with the use of noncontoured plates, suggesting that a decrease in hardware-related complications might be expected with the use of anatomic plates.
Disclaimer The authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.
References 1. B€ostman O, Manninen M, Pihlajam€aki H. Complications of plate fixation in fresh displaced midclavicular fractures. J Trauma 1997;43: 778-83.
1040 2. Campochiaro G, Tsatsis C, Gazzotti G, Rebuzzi M, Catani F. Displaced mid-shaft clavicular fractures: surgical treatment with a precontoured angular stability plate. Musculoskelet Surg 2012;96(Suppl 1):S21-6. http://dx.doi.org/10.1007/s12306-012-0196-1 3. 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;89:1-10. http://dx.doi.org/10.2106/JBJS.F.00020 4. Celestre P, Roberston C, Mahar A, Oka R, Meunier M, Schwartz A. Biomechanical evaluation of clavicle fracture plating techniques: does a locking plate provide improved stability? J Orthop Trauma 2008;22: 241-7. http://dx.doi.org/10.1097/BOT.0b013e31816c7bac 5. Chandrasenan J, Espag M, Dias R, Clark DI. The use of anatomic precontoured plates in the treatment of midshaft clavicle fractures. J Bone Joint Surg Br 2009;91(Suppl I):179-80. 6. Chen CH, Chen JC, Wang C, Tien YC, Chang JK, Hung SH. Semitubular plates for acutely displaced midclavicular fractures: a retrospective study of 111 patients followed for 2.5 to 6 years. J Orthop Trauma 2008; 22:463-6. http://dx.doi.org/10.1097/BOT.0b013e31817996fc 7. Chen YF, Wei HF, Zhang C, Zeng BF, Zhang CQ, Xue JF, et al. Retrospective comparison of titanium elastic nail (TEN) and reconstruction plate repair of displaced midshaft clavicular fractures. J Shoulder Elbow Surg 2012;21:495-501. http://dx.doi.org/10.1016/j. jse.2011.03.007 8. Collinge C, Devinney S, Herscovici D, DiPasquale T, Sanders R. Anterior-inferior plate fixation of middle-third fractures and nonunions of the clavicle. J Orthop Trauma 2006;20:680-6. http://dx.doi. org/10.1097/01.bot.0000249434.57571.29 9. Demirhan M, Bilsel K, Atalar AC, Bozdag E, Sunbuloglu E, Kale A. Biomechanical comparison of fixation techniques in midshaft clavicular fractures. J Orthop Trauma 2011;25:272-8. http://dx.doi.org/10. 1097/BOT.0b013e3181ee3db7 10. Formaini N, Taylor BC, Backes J, Bramwell TJ. Superior versus anteroinferior plating of clavicle fractures. Orthopedics 2013;36:e898904. http://dx.doi.org/10.3928/01477447-20130624-20 11. Galdi B, Yoon RS, Choung EW, Reilly MC, Sirkin M, Smith WR, et al. Anteroinferior 2.7-mm versus 3.5-mm plating for AO/OTA type B clavicle fractures: a comparative cohort clinical outcomes study. J Orthop Trauma 2013;27:121-5. http://dx.doi.org/10.1097/BOT. 0b013e3182693f32 12. Golish SR, Oliviero JA, Francke EI, Miller MD. A biomechanical study of plate versus intramedullary devices for midshaft clavicle fixation. J Orthop Surg Res 2008;3:28. http://dx.doi.org/10.1186/1749799X-3-28 13. Goswami T, Markert RJ, Anderson CG, Sundaram SS, Crosby LA. Biomechanical evaluation of a pre-contoured clavicle plate. J Shoulder Elbow Surg 2008;17:815-8. http://dx.doi.org/10.1016/j.jse.2008.02.017 14. 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. 15. Huang JI, Toogood P, Chen MR, Wilber JH, Cooperman DR. Clavicular anatomy and the applicability of precontoured plates. J Bone Joint Surg Am 2007;89:2260-5. http://dx.doi.org/10.2106/JBJS.G.00111 16. Kabak S, Halici M, Tuncel M, Avsarogullari L, Karaoglu S. Treatment of midclavicular nonunion: comparison of dynamic compression
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plating and low-contact dynamic compression plating techniques. J Shoulder Elbow Surg 2004;13:396-403. http://dx.doi.org/10.1016/j. jse.2004.01.033 Khan LA, Bradnock TJ, Scott C, Robinson CM. Fractures of the clavicle. J Bone Joint Surg Am 2009;91:447-60. http://dx.doi.org/10. 2106/JBJS.H.00034 Kloen P, Sorkin AT, Rubel IF, Helfet DL. Anteroinferior plating of midshaft clavicular nonunions. J Orthop Trauma 2002;16:425-30. Lai YC, Tarng YW, Hsu CJ, Chang WN, Yang SW, Renn JH. Comparison of dynamic and locked compression plates for treating midshaft clavicle fractures. Orthopedics 2012;35:e697-702. http://dx.doi. org/10.3928/01477447-20120426-24 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 McKee MD, Wild LM, Schemitsch EH. Midshaft malunions of the clavicle. J Bone Joint Surg Am 2003;85:790-7. McKee RC, Whelan DB, Schemitsch EH, McKee MD. Operative versus nonoperative care of displaced midshaft clavicular fractures: a meta-analysis of randomized clinical trials. J Bone Joint Surg Am 2012;94:675-84. http://dx.doi.org/10.2106/JBJS.J.01364 Mirzatolooei F. Comparison between operative and nonoperative treatment methods in the management of comminuted fractures of the clavicle. Acta Orthop Traumatol Turc 2011;45:34-40. http://dx.doi. org/10.3944/AOTT.2011.2431 Nowak J, Holgersson M, Larsson S. Sequelae from clavicular fractures are common: a prospective study of 222 patients. Acta Orthop 2005; 76:496-502. http://dx.doi.org/10.1080/17453670510041475 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 Robinson CM. Fractures of the clavicle in the adult. Epidemiology and classification. J Bone Joint Surg Br 1998;80:476-84. Schemitsch LA, Schemitsch EH, Veillette C, Zdero R, McKee MD. Function plateaus by one year in patients with surgically treated displaced midshaft clavicle fractures. Clin Orthop Relat Res 2011;469: 3351-5. http://dx.doi.org/10.1007/s11999-011-1915-x 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 Virtanen KJ, Remes V, Pajarinen J, Savolainen V, Bj€orkenheim J-M, 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 Xu C, Li X, Cui Z, Diao X, Yu B. Should displaced midshaft clavicular fractures be treated surgically? A meta-analysis based on current evidence. Eur J Orthop Surg Traumatol 2013;23:621-9. http:// dx.doi.org/10.1007/s00590-012-1063-3 Xu J, Xu L, Xu W, Gu Y, Xu J. Operative versus nonoperative treatment in the management of midshaft clavicular fractures: a metaanalysis of randomized controlled trials. J Shoulder Elbow Surg 2014;23:173-81. http://dx.doi.org/10.1016/j.jse.2013.06.025
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Surgical treatment of displaced midshaft clavicular fractures with precontoured plates Maximiliano Ranalletta, MD, Luciano A. Rossi, MD*, Santiago L. Bongiovanni, MD, Ignacio Tanoira, MD, Nicolas S. Piuzzi, MD, Gaston Maignon, MD Department of Orthopedics and Traumatology, Prof. Dr. Carlos E. Ottolenghi, Italian Hospital of Buenos Aires, Buenos Aires, Argentina Background: Plate fixation of displaced midshaft clavicular fractures has been shown to decrease nonunion, symptomatic malunion, and residual shoulder disability compared with nonoperative treatment. However hardware-related complications are a problem. The new features of the precontoured locking plates may reduce the need for hardware removal, thus maintaining the advantages of plate fixation. This study evaluated the clinical outcomes of patients with displaced midshaft clavicular fractures treated with precontoured locking plates. Materials and methods: From November 2008 to December 2012, we surgically treated 72 patients with displaced midshaft clavicular fractures. We retrospectively evaluated 68 patients who underwent 68 interventions. Postoperative functional outcomes were assessed with the Constant score, the 11-item version of the Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire, and radiographs. Pain was subjectively assessed with a visual analog scale. Complications were recorded. Patients were asked if they were able to return to their previous employment level. Results: The mean follow-up period was 23.6 10.7 months. The average values of the Constant, QuickDASH, and visual analog scale scores were 97.8, 1.8, and 0.4 points, respectively. At the last follow-up, 98.5% were able to return to their regular work. Of 15 complications (22.1%) that occurred, only 3 were considered as major: 1 subclavian vein extrinsic compression, 1 nonunion, and 1 hardware loosening. Hardware removal was required in 9 patients (13.2%). Conclusions: Satisfactory clinical results with a low rate of complications were achieved with precontoured locking plates for displaced midshaft clavicular fractures and a low rate of hardware removal compared with traditional plates. Level of evidence: Level IV, Case Series, Treatment Study. Ó 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Clavicular fracture; midshaft; precontoured; plates
This study was approved by the Ethics Committee of the Italian Hospital of Buenos Aires (IRB: 00003580, Study No.: 2320). *Reprint requests: Luciano A. Rossi, MD, Rawson 280, Appt 8A, Buenos Aires 1183, Argentina. E-mail address: [email protected] (L.A. Rossi).
Clavicular fractures are common injuries and account for approximately 2.6% to 5% of all fractures in adults. Middle-third fractures are the most common type, representing approximately 80% of all clavicular fractures, of which 48% are displaced and 19% are comminuted.25,26
1058-2746/$ - see front matter Ó 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. http://dx.doi.org/10.1016/j.jse.2014.12.013
Precontoured plates for displaced clavicular fractures
1037
Figure 1 A 45 up-tilted clavicle radiograph shows (A) a Robinson type 2B2 fracture (displaced, comminuted, and segmental) and (B) bony union and that the precontoured plate fits the anatomic shape of the biological clavicle.
Traditionally, nonsurgical management has been favored as the initial treatment for most clavicular fractures because the initial studies did not separate displaced and comminuted fractures from the whole.24,28 More recently, however, several studies showed suboptimal outcomes with nonoperative treatment in this subgroup of fractures.2,3,6,12 Hill et al14 reported a 15% incidence of nonunion and a 31% rate of unsatisfactory results in 52 patients with completely displaced midshaft clavicular fractures treated nonoperatively. Similar unfavorable outcomes with nonoperative treatment for displaced clavicular fractures were later updated by various studies.20,21,24,25 Several recent prospective, randomized clinical trials comparing nonoperative treatment with plate fixation showed that operative treatment improved functional outcomes and significantly decreased the incidence of longterm complications, such as nonunion and symptomatic malunion.3,23,27,29 However, several problems associated with plate fixation have been reported, including hardwarerelated complications, such as irritation, protrusion, or loosening, and wound complications (infection, dehiscence).17 The development of precontoured clavicle plates and the introduction of angular stability have paved the way for a new perspective on surgical treatment for theses fractures. The aim of this study was to analyze the clinical outcomes and hardware-related complications of a group of patients with displaced midshaft clavicular fractures treated using precontoured locking plates.
Materials and methods Seventy-two patients with 72 midshaft clavicular fractures (Fig. 1, A) were surgically treated at our unit with open reduction and precontoured angular stability plate fixation. Inclusion criteria were (a) patients aged between 16 and 70 years, (b) type 2B fractures according to Robinson’s classification,27 and (c) displacement (more than 2 cm). Exclusion criteria were (a) open fracture, (b) neurovascular injury, (c) a concomitant upper extremity injury, (d) pathologic fracture, (e) previous fracture in the same shoulder, and (f) lack of informed consent. The analysis consisted of 68 fractures in 68 patients because 4 patients were lost to follow-up.
Demographic and fracture characteristics were documented Patients were seen postoperatively at 1 week, 2 weeks, and monthly until fracture consolidation, and then once a year. Radiologic evaluation was obtained in the immediate postoperative day and monthly until fracture consolidation. Fracture consolidation was defined as complete periosteal and endosteal bridging visible between the medial and lateral fragments in at least 2 different radiographic views and the absence of pain and instability in the fracture region. Patients were evaluated at the last follow-up, by one of the authors (L.A.R.), using the Constant score and the 11-item version of the Disabilities of Arm, Shoulder and Hand (QuickDASH) score. Residual pain was evaluated using a visual analog scale (VAS), with 0 being ‘‘no pain’’ and 10 being ‘‘maximum pain.’’ All surgery-related complications and reoperations were documented. Patients were also asked if they had been able to practice sports again and if they had been able to perform them at the same level they had before the accident. Lastly, patients were asked if they were able to return to their previous work (Table I) Patients received combined anesthesia (regional blockade and general anesthesia) and were placed in the beach chair position with an enhancement behind the ipsilateral scapula. An anteriorinferior approach centered in the fracture site was used. Once anatomic fracture reduction was performed, we proceeded with fixation. A precontoured locking plate (Acumed, Hillsboro, OR, USA) was placed on the superior side of the clavicle (Fig. 1, B). Interfragmentary screws were used for fragment fixation when a third fragment was present. In each plate fixation, we used a minimum of 3 screws on each side of the fracture. The postoperative rehabilitation protocol consisted of an arm sling during the first 2 postoperative weeks. Pendulum motion was permitted during the first 3 weeks, followed by active abduction and flexion up to the horizontal plane from 3 to 6 weeks. Full shoulder active range of motion was allowed after 6 weeks, and return to full activities was permitted after 3 months.
Statistical methodology Continuous variables are presented as means standard deviations and categoric variables as absolute and relative frequencies. The statistical analysis was performed using STATA 12 software (StataCorp LP, College Station, TX, USA). A P value of <.05 was considered statistically significant.
1038 Table I
M. Ranalletta et al. Demographic and fracture-related characteristics
Variables Gender Male Female Age, y Dominant arm No Yes Robinson classification Subtype B1 Subtype B2 Mechanism of injury Sports Motorcycle Fall Car accident Bicycle Others
No. (%) or mean SD
Table II Summary of functional outcomes according to the Robinson classification Scores
54 (79.4) 14 (20.6) 33.1 11.9 30 (44.1) 38 (55.9) 49 (72) 19 (28) 27 18 9 7 5 2
(39.7) (26.5) (13.2) (10.3) (7.4) (2.9)
SD, standard deviation.
Results The series consisted of 54 men (79.4%) and 14 women (20.6%) with an average age of 33.1 11.9 years who presented with 37 fractures on the left side and 31 on the right side; 38 fractures (55.9%) were on the dominant side. All fractures were classified as group 2B according to the Robinson classification; specifically, 49 subtype B1 and 19 subtype B2 fractures were identified. The main cause of fracture was sport-related trauma, present in 27 patients (39.7%); with motorcycle-related accidents being the second most common reason, in 18 patients (26.5%; Table I). The average time to surgery was 9.3 6.0 days (range, 220 days). Average surgery time was 77 minutes (range, 40125 minutes). There were no major intraoperative complications. Average follow-up was 23.6 10.7 months (range, 1249 months). Sixty-seven fractures (98.5%) consolidated. The average Constant score was 97.8 6.4 points (range, 56-100 points). The average QuickDASH score was 1.8 4.8 points (range, 0-32 points). Pain during follow-up was at an average of 0.4 1.1 points (range, 0-6 points) according to the VAS. Considering the fracture type, according to the Robinson classification, there were no significant differences regarding functional outcomes (Table II). From the 61 patients who were active workers at the time of the accident, 60 (98.5%) were able to return to their previous working routine. Fifteen complications occurred in 14 patients (22.1%), and 3 of these complications (4.5%) were considered as major. The first consisted of a subclavian vein extrinsic compression by a long screw that protruded from the
Constant QuickDASH VAS
Subtype B1
Subtype B2
(Mean SD)
(Mean SD)
98.0 6.9 1.5 .4.8 0.3 0.9
97.2 5.0 2.6 4.8 0.6 1.3
P value* .661 .382 .232
QuickDASH, 11-item version of the Disabilities of Arm, Shoulder and Hand; SD, standard deviation; VAS, visual analog scale. ) P value derived from the Student t test.
Table III
Summary of complications Characteristic present)
No. (%)
Any complication Major complications Nonunion Hardware loosening Subclavian vein compression Minor complications Hardware removal Hypertrophic scar Superficial infection
15 3 1 1 1 12 9 2 1
)
(22.1) (4.5) (1.5) (1.5) (1.5) (17.6) (13.2) (2.9) (1.5)
The same patient can contribute to more than 1 category.
inferior side of the clavicle, requiring hardware removal. The second was an implant loosening. The patient was immobilized with a sling until fracture consolidation, and then the plate was removed. The third major complication was a nonunion. The implant was removed, the nonunion was decorticated, and a new reduction and osteosynthesis with a precontoured plate and addition of autologous iliac crest graft was performed. Twelve minor complications (17.6%) occurred (Table III). Plate removal was necessary after fracture consolidation in 9 patients (13.2%). Hardware was removed because of prominence and discomfort in 7 patients and pain in 2 patients. None of these patients had a refracture after 12 months from plate removal. The remaining 3 complications were 2 hypertrophic scars and 1 superficial wound infection that resolved with oral antibiotics. The reoperation rate was 16.1%. Excluding patients who underwent hardware removal, the overall revision rate was 2.9%.
Discussion Recent meta-analyses of randomized controlled trials comparing surgical vs nonoperative treatment of displaced clavicular fractures show greater prevalence of nonunion, symptomatic malunion, and poor functional outcomes after nonsurgical management.22,30,31 Despite the benefits of
Precontoured plates for displaced clavicular fractures Table IV Comparison of reported hardware removal rate for midshaft clavicular fractures treated with noncontoured and precontoured plates Study
Year
Type of plate
No.
Hardware removal rate, No. (%)
Kabak16 Chen6 Chandrasenan5
2004 2008 2008
VanBeek28
2011
Lai19 Campochiaro2 Our study
2012 2012 2014
Noncontoured Noncontoured Precontoured Noncontoured Precontoured Noncontoured Noncontoured Precontoured Precontoured
33 111 15 15 28 14 54 68 68
9/23 82/111 0/15 9/15 3/28 3/14 20/54 10/68 9/68
(39.1) (73.8) (0) (60) (10.7) (21.4) (37) (14.7) (13.2)
surgical treatment, the optimal implant for clavicular fixation remains controversial. Favorable outcomes were reported with plates,3,23,29 but there have been numerous related problems with these implants. The most frequently reported have been hardware irritation, protrusion, or loosening, and wound complications (infection, dehiscence).6,7,16,19 The aim of this retrospective study was to analyze the clinical outcome and complications of patients with displaced midshaft clavicular fractures treated using precontoured locking plates. The design features of precontoured plates may afford potential benefits. Firstly, they have the anatomic shape of the natural clavicle and a large modularity with available right and left clavicle fittings. This allows facing all types of midshaft fractures and may facilitate surgical technique. Secondly, the low profile and rounded edges could reduce the risk of postoperative hardware intolerance. Finally, the lower modulus of elasticity of titanium compared with stainless steel of other plates may lead to less stress shielding.13 Biomechanical and anatomical studies support the use of precontoured plates.4,5,9,13,15 However, evidence in the literature on clinical results with precontoured plates is still limited. Campochiaro et al2 retrospectively evaluated 68 of 89 patients treated with precontoured plates and showed excellent functional results, with only 14.3% plate removal after fracture consolidation. However, 24% of the patients were untraceable at follow-up, and lateral clavicular fractures were also included in the analysis. VanBeek et al28 retrospectively compared the outcomes of 24 patients treated with precontoured plates and 14 treated with noncontoured plates. Even though the study population size was limited, they showed higher hardware removal using noncontoured plates (21.4%) than using precontoured plates (10.7%). In our study, satisfactory clinical outcomes were obtained, similar to those reported previously with noncontoured plate fixation.3,23,27,29 Our overall complication rate was 22%, with a total reoperation rate of 16.1%.
1039 These results were consistent with previously published rates.1,3,5,23,29 Our hardware removal rate of 13.2% was lower than previously published rates of 28.6% to 76.7% with the use of noncontoured plates 6,7,16,19 (Table IV). The use of precontoured plates has not been the only attempt to decrease hardware discomfort. Anteriorinferior plating was described to address the issue of plate prominence.8,18 Formaini et al,10 showed, with similar time to radiographic union, that implant prominence was nearly double in patients with a retained superior plate compared with an anterior-inferior plate (54% vs 29%, respectively; P ¼ .04). Another described strategy has been the use of smaller plates. Galdi et al,11 found that compared with 3.5-mm anterior-inferior plating, 2.7-mm anterior-inferior plating for Arbeitsgemeinschaft fur Osteosynthesefragen/Orthopaedic Trauma Association type B clavicular fractures leads to significantly higher rates of cosmetic acceptability while reducing the need for a secondary procedure and achieving excellent clinical outcomes. Our study has several limitations. First, this was a retrospective study, and all data were collected from patient records. Second, there was no control group. Finally, all plates were placed superiorly on the clavicle; therefore, our findings cannot be generalized to plating of the clavicle in other locations.
Conclusions This study showed satisfactory clinical outcomes and a low complication rate in patients with displaced midshaft clavicular fractures treated using precontoured locking plates. The hardware removal rate was lower than rates reported with the use of noncontoured plates, suggesting that a decrease in hardware-related complications might be expected with the use of anatomic plates.
Disclaimer The authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.
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