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Anteroinferior versus superior plating of clavicular fractures
J Shoulder Elbow Surg (2015) -, 1-7
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Anteroinferior versus superior plating of clavicular fractures Martijn H.J. Hulsmans, MDa, Mark van Heijl, MD, PhDa, R. Marijn Houwert, MD, PhDa, Tim K. Timmers, MD, PhDb, Ger van Olden, MD, PhDb, Egbert Jan M.M. Verleisdonk, MD, PhDa,* a b
Department of Surgery, Diakonessenhuis Utrecht/Zeist/Doorn, Utrecht, The Netherlands Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands Background: Open reduction and plate fixation has gained recognition as an effective treatment for certain types of clavicular fractures. However, 88% of cases report some implant-related problems. To determine the optimal plate position, the aim of the present study was to compare implant-related irritation and proportion of plate removal in patients with clavicular fractures undergoing plate fixation by an anteroinferior or superior approach. Methods: Retrospectively collected data of 39 patients who underwent anteroinferior plating for displaced midshaft clavicular fractures were compared with prospectively collected data of 60 patients who were treated with superior plate fixation as part of a multicenter randomized controlled trial. Electronic medical records were reviewed for reports of complications, in particular, implant-related irritation and implant removal during follow-up. In addition, all patients were contacted in June 2014 to obtain additional information. The primary outcome parameter was implant-related irritation. Results: Univariate and multivariate regression analysis showed plate position was not significantly associated with implant-related irritation. Higher rates of asymptomatic patients with the plate still in place were observed in the anteroinferior group (46% vs 22%, P ¼ .01). Almost an equal percentage of implant removals was seen in both groups because of implant irritation (36% vs 37%, P ¼ .938). Conclusions: The present study found the surgical approach of clavicular plating was not associated with implant-related irritation. Future studies are needed to determine whether there is an optimal approach for clavicle plating. Level of Evidence: Level III, Retrospective Cohort Design, Treatment Study. Ó 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Clavicular fracture; displaced; midshaft; ORIF; plate fixation; superior; anteroinferior; irritation
This was a retrospective data study, and formal approval of the Medical Ethical Committee was not required. Approval for prospectively collected data was granted by the Verenigde Commissies Mensgebonden Onderzoek (VCMO; United Commissions of Human Related Research). The study number: R-10.18D/Dutch Trial Register. NTR2438. *Reprint requests: Egbert Jan M.M. Verleisdonk, MD, PhD, Department of Surgery, Diakonessenhuis Utrecht/Zeist, Bosboomstraat 1, NL3582 KE Utrecht, The Netherlands. E-mail address: [email protected] (E.J.M.M. Verleisdonk).
Clavicular fractures are common orthopedic injuries.21,24 Management of these fractures has evolved over the past 2 decades. These injuries have traditionally been treated nonoperatively, with most patients having successful outcomes.20,26,28 However, more recent literature has shown increased rates of nonunion, symptomatic malunion, and unsatisfactory patient outcomes with nonoperative
1058-2746/$ - see front matter Ó 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. http://dx.doi.org/10.1016/j.jse.2015.09.005
2 management of displaced midshaft clavicular fractures (DMCF).3,17-19 The decision to treat clavicular fractures operatively or nonoperatively remains a topic of debate.27 A shift toward surgical treatment has been seen in recent decades, and parameters to be evaluated favoring operation are displacement, shortening or comminution of the fracture, gender, and age.18,19,26 If the decision is to treat a clavicular fracture surgically, open reduction and plate fixation has gained recognition as an effective treatment for certain clavicular fractures, leading to union rates of 94% to 100% accompanied by a low rate of associated complications.3,8,17,19,22,31,38 Two different surgical approaches for clavicular plating have been described, in which the plate is positioned on the anteroinferior or superior surface of the clavicle.3,7 Both techniques seem to have certain advantages and disadvantages. A biomechanical comparison revealed that clavicles plated at the superior surface exhibit greater biomechanical stability than those plated at the anterior aspect.12 A potential benefit of anteroinferior plating is that drilling as well as screw placement in an anteroinferior-to-posterior direction should reduce the risk of damaging the underlying neurovascular bundle compared with an inferior direction.6,29,30 Another possible advantage of the anteroinferior position is that it may reduce implant prominence.6,13,15 However, due to the subcutaneous position, implant-related irritation has been reported in both plating techniques, ranging from 0% to 16% after anteroinferior plating1,5,6,16,32 and from 9% to 88% after superior plating.34,36,37 Some of these complications will result in implant removal requiring additional surgery.2 Plate removal, in addition to general risks associated with surgery and anesthesia, carries an increased risk of refracture.21 Because of the advantages and disadvantages seen in both techniques, which approach is better is still unclear. Therefore, the aim of the present study was to determine the optimal plate position comparing implant-related irritation and the proportion of plate removal in patients with clavicular fractures undergoing plate fixation by an anteroinferior approach or a superior approach.
Materials and methods Study design A retrospective analysis of the surgical databases of 5 Dutch hospitals was performed in which patients treated with anteroinferior plating were compared with patients treated with superior plating. All patients who underwent open reduction and anteroinferior plating in the Meander Medical Center for midshaft fractures of the clavicle between November 2008 and June 2013 were eligible for inclusion in the anteroinferior group. Data on patients who were treated with superior plate fixation as part of a multicenter, randomized, controlled trial were used for
M.H.J. Hulsmans et al. comparison. In this previously reported Plate or Pin study, plate fixation was compared with intramedullary pin fixation in patients with a DMCF and included patients from January 2011 until August 2012.34
Study population The 5 participating hospitals were level 1 (St. Elisabeth Hospital, Medical Center Haaglanden) or level 2 (Meander Medical Center, Antonius Hospital Nieuwegein, and Diakonessen Hospital, Utrecht) trauma centers, which are all regional teaching hospitals. Anteroinferior plate fixation was performed or supervised by 1 trauma surgeon in the Meander Medical Center, and a total of 8 trauma surgeons performed or supervised the superior plate fixation in the other hospitals. Each surgeon had extensive experience (>20 procedures) with the surgical technique. In the anteroinferior group, acute fractures in the middle of the clavicle were treated surgically using plate fixation based on the surgeon’s and patient’s preference.35 Treatment of acute fractures was defined as surgery within 4 weeks after trauma. In the superior group, patients were randomized to superior plate fixation or intramedullary fixation. Only patients who underwent plate fixation were eligible for analysis in the current study. A DMCF was defined as displacement of at least 1 shaft width between the fracture parts.
Operative procedures Anteroinferior plate fixation Patients undergoing anteroinferior plate fixation35 were positioned in a beach chair, semisitting position. A gentle curvilinear incision was made parallel to the skin cleavage lines. Careful subcutaneous dissection was completed, followed by minimal dissection of the clavicle periosteum to expose the fracture. An appropriate plate length of the VA-LCP anterior clavicular plate (DePuy Synthes BV, Amersfoort, The Netherlands) was selected, ensuring the possibility of a minimum of 4 screws on each side of the fracture, and bent at each notch at the plane of the shaft for optimal fit. After correct plate insertion and placement at the anteroinferior surface of the clavicle, an image intensifier was used to check alignment on the bone and the position of the plate. The plate was first fixated using a locking screw in the most lateral plate hole. The image intensifier was then used to position the plate as laterally as possible without compromising the acromioclavicular joint. After the first (lateral) screw was inserted, the most medial nonlocking screw was positioned so that the plate was adequately engaged against the bone. The clavicle was predrilled, and the drill bit angle was verified under image intensification to ensure the correct angle had been achieved and that all screws were bicortical.
Superior plate fixation The patient was positioned in a beach chair, semisitting position. An incision was made over the fracture site. If possible, supraclavicular nerves were identified and spared, and the fracture site was identified. After fracture reduction, a plate was positioned and fixed on the anterosuperior surface of the clavicle starting medially using nonlocking screws (DePuy Synthes BV). Locking screws were placed on the outer sides of the plate. Specific plate
Clavicular fractures: anteroinferior vs superior plating types were used according to surgical preference. Ideally, a minimum of 3 bicortical screws was placed on each side of the fracture to ensure rigid fixation. If additional interfragmentary compression was necessary or possible, lag screws were placed. Only in fractures with severe comminution was a bridging plate used. Finally, fascia and skin were closed in layers.
Outcome parameters The electronic medical records were reviewed for baseline patient and implant characteristics, complications, and implant removal during follow-up. Complications that were noted included infection, implant-related irritation, implant breakage, nonunion, and refracture after implant removal. Reinterventions needed to treat these complications were also noted. In addition, all patients were contacted in June 2014 to obtain additional information regarding implant-related pain, prominence, or removal. Patients were followed up until the implant was removed or, if the implant was still in place, until they were contacted in June 2014. The primary outcome parameter was implant-related irritation. This topic was discussed at each outpatient clinic visit and again when all were contacted in June 2014. To further classify the subject, we consistently used standardized questions to divide patients into 6 groups: (1) plate still in place, no irritation; (2) plate still in place, experiencing irritation, but implant removal not necessary; (3) plate still in place, experiencing irritation, but no request for removal due to fear for reoperation; (4) plate still in place, experiencing irritation, considering removal; (5) implant removed on patient’s request without irritation; and (6) implant removed due to implant related irritation.
Statistical analysis Baseline characteristics and postoperative implant-related irritation are presented as mean standard deviation (SD) or ranges for continuous variables and were compared using Student t tests. Data for categoric variables are presented as absolute numbers (percentage) and were compared using Pearson c2 test or the Fisher exact test for increased accuracy in small proportion analysis. Patient age, gender, fracture side, and the surgical technique were tested as risk factors for implant-related irritation. These factors were assessed using univariate logistic regression and are presented as odds ratios. The mean patient age was used as optimal cutoff value for age as a predictor for implant-related irritation. Factors with a P value of <.15 in univariate analysis were then assessed by multivariate logistic regression. Surgical technique was the determinant of interest and therefore added to the multivariate regression regardless of the P value. P value <.05 was considered statistically significant. Statistical analyses were performed using SPSS 17.0.0 software (IBM Corp, Armonk, NY, USA).
Results Open reduction and plate fixation was performed in 136 patients: 74 patients underwent anteroinferior, and 62 patients underwent superior plating. Thirty patients were excluded because treatment concerned delayed or nonunions, lateral third fractures, or insufficient follow-up.
3 Table I Variables
Baseline characteristics Anteroinferior plating (n ¼ 39)
Age, mean SD, y 40.3 11.5 Gender, No. (%) Male 36 (92) Female 3 (8) Fracture side, No. (%) Right 19 (49) Left 20 (51) Plate length, 9.0 2.0 mean SD holes
Superior plating (n ¼ 60) 38.6 14.6 55 (92) 5 (8) 31 (52) 29 (48) 7.0 1.0
P value
.524 1.00)
.774 <.001y
SD, standard deviation. ) Fisher exact test. y Statistically significant (P < .05).
Seven patients could not be reached in June 2014 and were lost to follow-up, resulting in a 99 patients eligible for the current analysis. The group with anteroinferior plate fixation consisted of 39 patients and the group with superior plate fixation consisted of 60 patients. The groups did not differ significantly in age, gender, or affected side (Table I). A significant difference was seen in the length of the plates used in both groups, measured in number of holes, with a significantly longer plate length in the anteroinferior group (9.0 2.0 vs 7.0 1.0, P < .001; Table I). A statistically significant difference was observed in the mean follow-up time between the anteroinferior and superior group (P ¼ .044). Patients in both groups with the plate still in place had a follow-up time of at least 1 year. In both groups, 7 complications were observed other than implantrelated irritation. No significant difference was seen between the 2 groups regarding these various complications (Table II). Complaints of implant-related irritation were documented in 51% of the patients in the group treated with an anteroinferior plate compared with 68% of the patients in the superior plating group (P ¼ .09, Table III). In the anteroinferior group, 46% had no complaints with the plate still in place vs 22% in the superior group (P ¼ .01). The implant was removed in 43% of all patients: 39% of the patients in the anteroinferior group and 47% of the patients in the superior group (P ¼ .421). Plate removals in 3% of the anteroinferior group and in 10% in the superior group were at the patient’s request but were asymptomatic (P ¼ .24). The remaining (36% vs 37%) were removed due to implant-related soft tissue irritation (P ¼ .938). Univariate logistic regression analysis was used to identify potential risk factors for development of implantrelated irritation. The analysis showed that patient age <40 years (P ¼ .023) was significantly associated with
4
M.H.J. Hulsmans et al. Table II
Implant-related irritation and removal
Variables
Treatment
Follow-up, mean SD mo Infection, No. (%) Implant breakage, No. (%) Screw pullout, No. (%) Nonunion, No. (%) Refracture after implant removal, No. (%) Implant-related irritation Plate still in place No irritation Experiencing irritation, but implant removal not necessary Experiencing irritation, but no request for removal due to fear for reoperation Experiencing irritation, considering removal Implant removed, No. (%) By patient request without irritation Due to implant-related irritation
Antibiotics Revision þ bone graft Revision Revision þ bone graft Revision
Anteroinferior plating (n ¼ 39)
Superior plating (n ¼ 60)
P value
27 3 1 1 0 2
21 3 1 0 1 2
.044) .678y 1.00y .394y 1.00y .645y
(19) (8) (3) (3) (0) (5)
(11) (5) (2) (0) (2) (3)
– –
18 (46) 4 (10)
13 (22) 12 (20)
.01) .268y
–
0 (0)
3 (5)
.276y
–
2 (5)
4 (6)
1 (3) 14 (36)
6 (10) 22 (37)
Implant removal Implant removal
1.00y .24y .938
SD, standard deviation. ) Statistically significant (P < .05). y Fisher exact test.
Table III Variables
Factors associated with implant-related irritation in patients with clavicular fractures Irritation No irritation Univariate analysis)
Age >40 years <40 years Gender Male Female Fracture side Right Left Surgical technique Anteroinferior Superior
Multivariate analysis)
(n ¼ 61) No. (%)
(n ¼ 38) No. (%)
OR (95% CI)
P value
OR (95% CI)
P value
24 (50) 37 (73)
26 (50) 14 (27)
2.64 (1.15-6.10)
.023)
2.70 (1.14-6.37)
.024y
54 (59) 7 (88)
37 (41) 1 (12)
4.80 (0.56-40.63)
.15
5.14 (0.58-45.16)
.14
28 (56) 33 (67)
22 (44) 16 (33)
1.62 (0.72-3.67)
.247
20 (51) 41 (68)
19 (49) 19 (32)
2.05 (0.89-4.71)
.09
2.04 (0.86-4.85)
.108
CI, confidence interval; OR, odds ratio. ) Univariate and multivariate analysis were performed by logistic regression. The factors with P value <.15 at univariate analysis were selected into multivariate analysis. y Statistically significant (P < .05).
irritation, whereas gender, fracture side, and plate position were not. Multivariate logistic regression showed patient age <40 years was independently associated with the development of implant-related irritation (P ¼ .024).
Discussion Although the decision to treat clavicular fractures conservatively or operatively is still being debated, a shift towards
surgical treatment has been seen in recent decades, and open reduction and plate fixation is one of the current treatments of choice when the decision is to treat a clavicular fracture surgically. Despite good functional outcome and bone healing, complications (especially implant related) are often seen after surgery. To determine whether there is an optimal plating technique regarding implant related irritation, this study aimed to compare the 2 most commonly used plating techniques, an anteroinferior vs a superior approach.
Clavicular fractures: anteroinferior vs superior plating The present study demonstrated an equal removal of implants due to implant-related irritation (36% vs 37%), although implant removal rates were higher in the superior plating group. In the anteroinferior group, 3% requested implant removal without any complaints of irritation, whereas 10% of the patients in the superior group requested implant removal without irritation. We believe there will always be some patients who will be asymptomatic after plate fixation of DMCF but still request implant removal because they are uncomfortable with having an implant in their body after the fracture has healed. In the group in which the plate was still in place at least 1 year after surgery, a higher proportion of patients treated with an anteroinferior approach reported no irritation (46% vs 22% respectively, P ¼ .01). Patients treated with an anteroinferior plate as well as patients treated with a superior plate showed relatively high rates of implant-related irritation. Therefore, in multivariate regression analysis, surgical approach was not a significant predictor of implant-related irritation. In contrast, age proved to be statistically significant and independently associated with the development of implant-related irritation after plate fixation. Wang et al36 assessed whether clavicular plates cause symptoms when left in place and reported high overall rates of prominence, pain, and discomfort (88%) after superior plate fixation. The proportion of patients in the Wang study with the plate still in place considering removal was twice as high (14%) as the proportion found in the present study (7%), whereas the proportion of patients experiencing irritation, but for whom implant removal was not necessary, was almost similar (19%). Finally, they reported that clinical symptoms were particularly seen in younger patients,36 which was observed in the present study as well. This may be explained by the fact that younger people are more often exposed to (athletic) activities that cause them to be more aware of their constraints. That implant-related irritation is caused by early biomechanical implant failure could be hypothesized. In the literature, proponents of both anteroinferior and superior plating were seen. Some studies conclude that anteroinferior plating is preferred because of a more stable construct against deformation as a result of the increase in bending rigidity and construct stiffness.9,11,23,33 Robertson et al25 stated, however, that anteroinferior reconstruction plates may be insufficient for fracture fixation because they plastically deform at a bending failure load in the coronal plane that could be seen in routine activity. Other studies report greater biomechanical stability after superior plating and favor this treatment in load to failure as well as bending failure stiffness, which is a measure for deformation loads.4,12,14 Because of these contradictory results on biomechanical outcome and differences in testing mode, concluding whether anteroinferior or superior plating should be the optimal plating technique for clavicular fractures from a biomechanical point of view is difficult.
5 One study directly compared clinical outcome and complications after anteroinferior and superior plating.10 Formaini et al10 reported less implant-related irritation in the anteroinferior group than in the superior group (29% vs 54%) and a lower rate of implant removal (9% vs 19%). This is similar to our data, even though higher overall irritation (51% vs 68%) and removal rates (38% vs 47%) were documented in the present study. Formaini et al10 state that both techniques are safe treatment options for clavicular fractures. Our data indicated that in patients with the plate still in place, an anteroinferior position was associated with a significantly higher rate of patients without implant-related irritation compared with a superior position (46% vs 22%). Our study has several limitations that need to be addressed. First, the retrospective study design has obvious limitations. Although irritation was discussed with all patients contacted in June 2014, some information could be lost due to inadequate patient reports. Second, patients in the superior group were randomized to this surgical procedure, whereas anteroinferior repair was by the surgeon’s or the patient’s preference. Because biomechanical studies show that a different plate or plate location is favored in different fracture types in plate construct stability, the potential selection bias may have affected the outcome in the anteroinferior group.8,11,12,23 However, if the decision was to treat a clavicular fracture surgically, in the hospital of the anteroinferior group, only the anteroinferior technique is used, whereas in the other contributing hospitals, the superior technique is used. Therefore we believe a proper comparison could be made. Third, the nonsignificant difference may be due to the small sample size and compromises the results, leading to false-negative results. The next limitation is inherent to the study’s multicenter and multisurgeon design. The interhospital and intersurgeon variation of participating centers in dealing with implant removal could have influenced the proportion of implant removals. This may have influenced each patient’s subsequent assessment about his or her plates. We believe, however, that interhospital and intersurgeon variation does reflect daily clinical practice, and therefore, these results can be acknowledged as representative. Furthermore, 4 patients in the anteroinferior group and 3 patients in the superior group were lost to follow-up. They could not be reached in June 2014 and were not included for analysis. The analysis of the surgical databases did not show any complications for these patients. Finally, no standardized and validated irritation scale is currently available to classify irritation.
Conclusion The present study found that an anteroinferior surgical approach and superior approach showed no significant
6
M.H.J. Hulsmans et al. difference in rates of implant-related irritation after a follow-up of at least 1 year. In a subgroup of patients in whom the plate was still in place, an anteroinferior position of the plate resulted in a higher proportion of patients without any complaints of irritation. To determine, however, more definitely whether there is an optimal approach for clavicular plating, plating position should be investigated in future studies, preferably in a randomized, prospective setting.
9.
10.
11.
12.
Acknowledgment 13.
We thank M. Verhofstad, PhD, S. Meylaerts, PhD, and E. Hammacher, PhD, for their contributions concerning the Plate or Pin trial. We thank O.A.J. van der Meijden, PhD, for his help in editing the manuscript.
14. 15. 16.
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.
17.
18.
19.
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midshaft clavicle fractures; plate or intramedullary pin fixation? A randomized controlled trial. J Bone Joint Surg Am 2015;15:613-9. http://dx.doi.org/10.2106/JBJS.N.00449 van Olden GD. VA-LCP anterior clavicle plate: the anatomically precontoured fixation system with angular stability for clavicle shaft. Musculoskelet Surg 2014;98:217-23. http://dx.doi.org/10.1007/ s12306-013-0302-z Wang J, Chidambaram R, Mok D. Is removal of clavicle plate after fracture union necessary? Int J Shoulder Surg 2011;5:85-9. http://dx. doi.org/10.4103/0973-6042.90998 Wijdicks FJ, Van der Meijden OA, Millett PJ, Verleisdonk EJ, Houwert RM. Systematic review of the complications of plate fixation of clavicle fractures. Arch Orthop Trauma Surg 2012;132:617-25. http://dx.doi.org/10.1007/s00402-011-1456-5 Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD. 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.
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Anteroinferior versus superior plating of clavicular fractures Martijn H.J. Hulsmans, MDa, Mark van Heijl, MD, PhDa, R. Marijn Houwert, MD, PhDa, Tim K. Timmers, MD, PhDb, Ger van Olden, MD, PhDb, Egbert Jan M.M. Verleisdonk, MD, PhDa,* a b
Department of Surgery, Diakonessenhuis Utrecht/Zeist/Doorn, Utrecht, The Netherlands Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands Background: Open reduction and plate fixation has gained recognition as an effective treatment for certain types of clavicular fractures. However, 88% of cases report some implant-related problems. To determine the optimal plate position, the aim of the present study was to compare implant-related irritation and proportion of plate removal in patients with clavicular fractures undergoing plate fixation by an anteroinferior or superior approach. Methods: Retrospectively collected data of 39 patients who underwent anteroinferior plating for displaced midshaft clavicular fractures were compared with prospectively collected data of 60 patients who were treated with superior plate fixation as part of a multicenter randomized controlled trial. Electronic medical records were reviewed for reports of complications, in particular, implant-related irritation and implant removal during follow-up. In addition, all patients were contacted in June 2014 to obtain additional information. The primary outcome parameter was implant-related irritation. Results: Univariate and multivariate regression analysis showed plate position was not significantly associated with implant-related irritation. Higher rates of asymptomatic patients with the plate still in place were observed in the anteroinferior group (46% vs 22%, P ¼ .01). Almost an equal percentage of implant removals was seen in both groups because of implant irritation (36% vs 37%, P ¼ .938). Conclusions: The present study found the surgical approach of clavicular plating was not associated with implant-related irritation. Future studies are needed to determine whether there is an optimal approach for clavicle plating. Level of Evidence: Level III, Retrospective Cohort Design, Treatment Study. Ó 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Clavicular fracture; displaced; midshaft; ORIF; plate fixation; superior; anteroinferior; irritation
This was a retrospective data study, and formal approval of the Medical Ethical Committee was not required. Approval for prospectively collected data was granted by the Verenigde Commissies Mensgebonden Onderzoek (VCMO; United Commissions of Human Related Research). The study number: R-10.18D/Dutch Trial Register. NTR2438. *Reprint requests: Egbert Jan M.M. Verleisdonk, MD, PhD, Department of Surgery, Diakonessenhuis Utrecht/Zeist, Bosboomstraat 1, NL3582 KE Utrecht, The Netherlands. E-mail address: [email protected] (E.J.M.M. Verleisdonk).
Clavicular fractures are common orthopedic injuries.21,24 Management of these fractures has evolved over the past 2 decades. These injuries have traditionally been treated nonoperatively, with most patients having successful outcomes.20,26,28 However, more recent literature has shown increased rates of nonunion, symptomatic malunion, and unsatisfactory patient outcomes with nonoperative
1058-2746/$ - see front matter Ó 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. http://dx.doi.org/10.1016/j.jse.2015.09.005
2 management of displaced midshaft clavicular fractures (DMCF).3,17-19 The decision to treat clavicular fractures operatively or nonoperatively remains a topic of debate.27 A shift toward surgical treatment has been seen in recent decades, and parameters to be evaluated favoring operation are displacement, shortening or comminution of the fracture, gender, and age.18,19,26 If the decision is to treat a clavicular fracture surgically, open reduction and plate fixation has gained recognition as an effective treatment for certain clavicular fractures, leading to union rates of 94% to 100% accompanied by a low rate of associated complications.3,8,17,19,22,31,38 Two different surgical approaches for clavicular plating have been described, in which the plate is positioned on the anteroinferior or superior surface of the clavicle.3,7 Both techniques seem to have certain advantages and disadvantages. A biomechanical comparison revealed that clavicles plated at the superior surface exhibit greater biomechanical stability than those plated at the anterior aspect.12 A potential benefit of anteroinferior plating is that drilling as well as screw placement in an anteroinferior-to-posterior direction should reduce the risk of damaging the underlying neurovascular bundle compared with an inferior direction.6,29,30 Another possible advantage of the anteroinferior position is that it may reduce implant prominence.6,13,15 However, due to the subcutaneous position, implant-related irritation has been reported in both plating techniques, ranging from 0% to 16% after anteroinferior plating1,5,6,16,32 and from 9% to 88% after superior plating.34,36,37 Some of these complications will result in implant removal requiring additional surgery.2 Plate removal, in addition to general risks associated with surgery and anesthesia, carries an increased risk of refracture.21 Because of the advantages and disadvantages seen in both techniques, which approach is better is still unclear. Therefore, the aim of the present study was to determine the optimal plate position comparing implant-related irritation and the proportion of plate removal in patients with clavicular fractures undergoing plate fixation by an anteroinferior approach or a superior approach.
Materials and methods Study design A retrospective analysis of the surgical databases of 5 Dutch hospitals was performed in which patients treated with anteroinferior plating were compared with patients treated with superior plating. All patients who underwent open reduction and anteroinferior plating in the Meander Medical Center for midshaft fractures of the clavicle between November 2008 and June 2013 were eligible for inclusion in the anteroinferior group. Data on patients who were treated with superior plate fixation as part of a multicenter, randomized, controlled trial were used for
M.H.J. Hulsmans et al. comparison. In this previously reported Plate or Pin study, plate fixation was compared with intramedullary pin fixation in patients with a DMCF and included patients from January 2011 until August 2012.34
Study population The 5 participating hospitals were level 1 (St. Elisabeth Hospital, Medical Center Haaglanden) or level 2 (Meander Medical Center, Antonius Hospital Nieuwegein, and Diakonessen Hospital, Utrecht) trauma centers, which are all regional teaching hospitals. Anteroinferior plate fixation was performed or supervised by 1 trauma surgeon in the Meander Medical Center, and a total of 8 trauma surgeons performed or supervised the superior plate fixation in the other hospitals. Each surgeon had extensive experience (>20 procedures) with the surgical technique. In the anteroinferior group, acute fractures in the middle of the clavicle were treated surgically using plate fixation based on the surgeon’s and patient’s preference.35 Treatment of acute fractures was defined as surgery within 4 weeks after trauma. In the superior group, patients were randomized to superior plate fixation or intramedullary fixation. Only patients who underwent plate fixation were eligible for analysis in the current study. A DMCF was defined as displacement of at least 1 shaft width between the fracture parts.
Operative procedures Anteroinferior plate fixation Patients undergoing anteroinferior plate fixation35 were positioned in a beach chair, semisitting position. A gentle curvilinear incision was made parallel to the skin cleavage lines. Careful subcutaneous dissection was completed, followed by minimal dissection of the clavicle periosteum to expose the fracture. An appropriate plate length of the VA-LCP anterior clavicular plate (DePuy Synthes BV, Amersfoort, The Netherlands) was selected, ensuring the possibility of a minimum of 4 screws on each side of the fracture, and bent at each notch at the plane of the shaft for optimal fit. After correct plate insertion and placement at the anteroinferior surface of the clavicle, an image intensifier was used to check alignment on the bone and the position of the plate. The plate was first fixated using a locking screw in the most lateral plate hole. The image intensifier was then used to position the plate as laterally as possible without compromising the acromioclavicular joint. After the first (lateral) screw was inserted, the most medial nonlocking screw was positioned so that the plate was adequately engaged against the bone. The clavicle was predrilled, and the drill bit angle was verified under image intensification to ensure the correct angle had been achieved and that all screws were bicortical.
Superior plate fixation The patient was positioned in a beach chair, semisitting position. An incision was made over the fracture site. If possible, supraclavicular nerves were identified and spared, and the fracture site was identified. After fracture reduction, a plate was positioned and fixed on the anterosuperior surface of the clavicle starting medially using nonlocking screws (DePuy Synthes BV). Locking screws were placed on the outer sides of the plate. Specific plate
Clavicular fractures: anteroinferior vs superior plating types were used according to surgical preference. Ideally, a minimum of 3 bicortical screws was placed on each side of the fracture to ensure rigid fixation. If additional interfragmentary compression was necessary or possible, lag screws were placed. Only in fractures with severe comminution was a bridging plate used. Finally, fascia and skin were closed in layers.
Outcome parameters The electronic medical records were reviewed for baseline patient and implant characteristics, complications, and implant removal during follow-up. Complications that were noted included infection, implant-related irritation, implant breakage, nonunion, and refracture after implant removal. Reinterventions needed to treat these complications were also noted. In addition, all patients were contacted in June 2014 to obtain additional information regarding implant-related pain, prominence, or removal. Patients were followed up until the implant was removed or, if the implant was still in place, until they were contacted in June 2014. The primary outcome parameter was implant-related irritation. This topic was discussed at each outpatient clinic visit and again when all were contacted in June 2014. To further classify the subject, we consistently used standardized questions to divide patients into 6 groups: (1) plate still in place, no irritation; (2) plate still in place, experiencing irritation, but implant removal not necessary; (3) plate still in place, experiencing irritation, but no request for removal due to fear for reoperation; (4) plate still in place, experiencing irritation, considering removal; (5) implant removed on patient’s request without irritation; and (6) implant removed due to implant related irritation.
Statistical analysis Baseline characteristics and postoperative implant-related irritation are presented as mean standard deviation (SD) or ranges for continuous variables and were compared using Student t tests. Data for categoric variables are presented as absolute numbers (percentage) and were compared using Pearson c2 test or the Fisher exact test for increased accuracy in small proportion analysis. Patient age, gender, fracture side, and the surgical technique were tested as risk factors for implant-related irritation. These factors were assessed using univariate logistic regression and are presented as odds ratios. The mean patient age was used as optimal cutoff value for age as a predictor for implant-related irritation. Factors with a P value of <.15 in univariate analysis were then assessed by multivariate logistic regression. Surgical technique was the determinant of interest and therefore added to the multivariate regression regardless of the P value. P value <.05 was considered statistically significant. Statistical analyses were performed using SPSS 17.0.0 software (IBM Corp, Armonk, NY, USA).
Results Open reduction and plate fixation was performed in 136 patients: 74 patients underwent anteroinferior, and 62 patients underwent superior plating. Thirty patients were excluded because treatment concerned delayed or nonunions, lateral third fractures, or insufficient follow-up.
3 Table I Variables
Baseline characteristics Anteroinferior plating (n ¼ 39)
Age, mean SD, y 40.3 11.5 Gender, No. (%) Male 36 (92) Female 3 (8) Fracture side, No. (%) Right 19 (49) Left 20 (51) Plate length, 9.0 2.0 mean SD holes
Superior plating (n ¼ 60) 38.6 14.6 55 (92) 5 (8) 31 (52) 29 (48) 7.0 1.0
P value
.524 1.00)
.774 <.001y
SD, standard deviation. ) Fisher exact test. y Statistically significant (P < .05).
Seven patients could not be reached in June 2014 and were lost to follow-up, resulting in a 99 patients eligible for the current analysis. The group with anteroinferior plate fixation consisted of 39 patients and the group with superior plate fixation consisted of 60 patients. The groups did not differ significantly in age, gender, or affected side (Table I). A significant difference was seen in the length of the plates used in both groups, measured in number of holes, with a significantly longer plate length in the anteroinferior group (9.0 2.0 vs 7.0 1.0, P < .001; Table I). A statistically significant difference was observed in the mean follow-up time between the anteroinferior and superior group (P ¼ .044). Patients in both groups with the plate still in place had a follow-up time of at least 1 year. In both groups, 7 complications were observed other than implantrelated irritation. No significant difference was seen between the 2 groups regarding these various complications (Table II). Complaints of implant-related irritation were documented in 51% of the patients in the group treated with an anteroinferior plate compared with 68% of the patients in the superior plating group (P ¼ .09, Table III). In the anteroinferior group, 46% had no complaints with the plate still in place vs 22% in the superior group (P ¼ .01). The implant was removed in 43% of all patients: 39% of the patients in the anteroinferior group and 47% of the patients in the superior group (P ¼ .421). Plate removals in 3% of the anteroinferior group and in 10% in the superior group were at the patient’s request but were asymptomatic (P ¼ .24). The remaining (36% vs 37%) were removed due to implant-related soft tissue irritation (P ¼ .938). Univariate logistic regression analysis was used to identify potential risk factors for development of implantrelated irritation. The analysis showed that patient age <40 years (P ¼ .023) was significantly associated with
4
M.H.J. Hulsmans et al. Table II
Implant-related irritation and removal
Variables
Treatment
Follow-up, mean SD mo Infection, No. (%) Implant breakage, No. (%) Screw pullout, No. (%) Nonunion, No. (%) Refracture after implant removal, No. (%) Implant-related irritation Plate still in place No irritation Experiencing irritation, but implant removal not necessary Experiencing irritation, but no request for removal due to fear for reoperation Experiencing irritation, considering removal Implant removed, No. (%) By patient request without irritation Due to implant-related irritation
Antibiotics Revision þ bone graft Revision Revision þ bone graft Revision
Anteroinferior plating (n ¼ 39)
Superior plating (n ¼ 60)
P value
27 3 1 1 0 2
21 3 1 0 1 2
.044) .678y 1.00y .394y 1.00y .645y
(19) (8) (3) (3) (0) (5)
(11) (5) (2) (0) (2) (3)
– –
18 (46) 4 (10)
13 (22) 12 (20)
.01) .268y
–
0 (0)
3 (5)
.276y
–
2 (5)
4 (6)
1 (3) 14 (36)
6 (10) 22 (37)
Implant removal Implant removal
1.00y .24y .938
SD, standard deviation. ) Statistically significant (P < .05). y Fisher exact test.
Table III Variables
Factors associated with implant-related irritation in patients with clavicular fractures Irritation No irritation Univariate analysis)
Age >40 years <40 years Gender Male Female Fracture side Right Left Surgical technique Anteroinferior Superior
Multivariate analysis)
(n ¼ 61) No. (%)
(n ¼ 38) No. (%)
OR (95% CI)
P value
OR (95% CI)
P value
24 (50) 37 (73)
26 (50) 14 (27)
2.64 (1.15-6.10)
.023)
2.70 (1.14-6.37)
.024y
54 (59) 7 (88)
37 (41) 1 (12)
4.80 (0.56-40.63)
.15
5.14 (0.58-45.16)
.14
28 (56) 33 (67)
22 (44) 16 (33)
1.62 (0.72-3.67)
.247
20 (51) 41 (68)
19 (49) 19 (32)
2.05 (0.89-4.71)
.09
2.04 (0.86-4.85)
.108
CI, confidence interval; OR, odds ratio. ) Univariate and multivariate analysis were performed by logistic regression. The factors with P value <.15 at univariate analysis were selected into multivariate analysis. y Statistically significant (P < .05).
irritation, whereas gender, fracture side, and plate position were not. Multivariate logistic regression showed patient age <40 years was independently associated with the development of implant-related irritation (P ¼ .024).
Discussion Although the decision to treat clavicular fractures conservatively or operatively is still being debated, a shift towards
surgical treatment has been seen in recent decades, and open reduction and plate fixation is one of the current treatments of choice when the decision is to treat a clavicular fracture surgically. Despite good functional outcome and bone healing, complications (especially implant related) are often seen after surgery. To determine whether there is an optimal plating technique regarding implant related irritation, this study aimed to compare the 2 most commonly used plating techniques, an anteroinferior vs a superior approach.
Clavicular fractures: anteroinferior vs superior plating The present study demonstrated an equal removal of implants due to implant-related irritation (36% vs 37%), although implant removal rates were higher in the superior plating group. In the anteroinferior group, 3% requested implant removal without any complaints of irritation, whereas 10% of the patients in the superior group requested implant removal without irritation. We believe there will always be some patients who will be asymptomatic after plate fixation of DMCF but still request implant removal because they are uncomfortable with having an implant in their body after the fracture has healed. In the group in which the plate was still in place at least 1 year after surgery, a higher proportion of patients treated with an anteroinferior approach reported no irritation (46% vs 22% respectively, P ¼ .01). Patients treated with an anteroinferior plate as well as patients treated with a superior plate showed relatively high rates of implant-related irritation. Therefore, in multivariate regression analysis, surgical approach was not a significant predictor of implant-related irritation. In contrast, age proved to be statistically significant and independently associated with the development of implant-related irritation after plate fixation. Wang et al36 assessed whether clavicular plates cause symptoms when left in place and reported high overall rates of prominence, pain, and discomfort (88%) after superior plate fixation. The proportion of patients in the Wang study with the plate still in place considering removal was twice as high (14%) as the proportion found in the present study (7%), whereas the proportion of patients experiencing irritation, but for whom implant removal was not necessary, was almost similar (19%). Finally, they reported that clinical symptoms were particularly seen in younger patients,36 which was observed in the present study as well. This may be explained by the fact that younger people are more often exposed to (athletic) activities that cause them to be more aware of their constraints. That implant-related irritation is caused by early biomechanical implant failure could be hypothesized. In the literature, proponents of both anteroinferior and superior plating were seen. Some studies conclude that anteroinferior plating is preferred because of a more stable construct against deformation as a result of the increase in bending rigidity and construct stiffness.9,11,23,33 Robertson et al25 stated, however, that anteroinferior reconstruction plates may be insufficient for fracture fixation because they plastically deform at a bending failure load in the coronal plane that could be seen in routine activity. Other studies report greater biomechanical stability after superior plating and favor this treatment in load to failure as well as bending failure stiffness, which is a measure for deformation loads.4,12,14 Because of these contradictory results on biomechanical outcome and differences in testing mode, concluding whether anteroinferior or superior plating should be the optimal plating technique for clavicular fractures from a biomechanical point of view is difficult.
5 One study directly compared clinical outcome and complications after anteroinferior and superior plating.10 Formaini et al10 reported less implant-related irritation in the anteroinferior group than in the superior group (29% vs 54%) and a lower rate of implant removal (9% vs 19%). This is similar to our data, even though higher overall irritation (51% vs 68%) and removal rates (38% vs 47%) were documented in the present study. Formaini et al10 state that both techniques are safe treatment options for clavicular fractures. Our data indicated that in patients with the plate still in place, an anteroinferior position was associated with a significantly higher rate of patients without implant-related irritation compared with a superior position (46% vs 22%). Our study has several limitations that need to be addressed. First, the retrospective study design has obvious limitations. Although irritation was discussed with all patients contacted in June 2014, some information could be lost due to inadequate patient reports. Second, patients in the superior group were randomized to this surgical procedure, whereas anteroinferior repair was by the surgeon’s or the patient’s preference. Because biomechanical studies show that a different plate or plate location is favored in different fracture types in plate construct stability, the potential selection bias may have affected the outcome in the anteroinferior group.8,11,12,23 However, if the decision was to treat a clavicular fracture surgically, in the hospital of the anteroinferior group, only the anteroinferior technique is used, whereas in the other contributing hospitals, the superior technique is used. Therefore we believe a proper comparison could be made. Third, the nonsignificant difference may be due to the small sample size and compromises the results, leading to false-negative results. The next limitation is inherent to the study’s multicenter and multisurgeon design. The interhospital and intersurgeon variation of participating centers in dealing with implant removal could have influenced the proportion of implant removals. This may have influenced each patient’s subsequent assessment about his or her plates. We believe, however, that interhospital and intersurgeon variation does reflect daily clinical practice, and therefore, these results can be acknowledged as representative. Furthermore, 4 patients in the anteroinferior group and 3 patients in the superior group were lost to follow-up. They could not be reached in June 2014 and were not included for analysis. The analysis of the surgical databases did not show any complications for these patients. Finally, no standardized and validated irritation scale is currently available to classify irritation.
Conclusion The present study found that an anteroinferior surgical approach and superior approach showed no significant
6
M.H.J. Hulsmans et al. difference in rates of implant-related irritation after a follow-up of at least 1 year. In a subgroup of patients in whom the plate was still in place, an anteroinferior position of the plate resulted in a higher proportion of patients without any complaints of irritation. To determine, however, more definitely whether there is an optimal approach for clavicular plating, plating position should be investigated in future studies, preferably in a randomized, prospective setting.
9.
10.
11.
12.
Acknowledgment 13.
We thank M. Verhofstad, PhD, S. Meylaerts, PhD, and E. Hammacher, PhD, for their contributions concerning the Plate or Pin trial. We thank O.A.J. van der Meijden, PhD, for his help in editing the manuscript.
14. 15. 16.
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.
17.
18.
19.
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