Early Versus Delayed Operative Intervention in Displaced Clavicle Fractures

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1 ORIGINAL ARTICLE OTA HIGHLIGHT PAPER Early Versus Delayed Operative Intervention in Displaced Clavicle Fractures Avishek Das, MRCS, Katie E. Rollins, MRCS, Kathleen Elliott, MRCS, Philip Johnston, MD, FRCS (Tr and Orth), Lee van-rensburg, FRCS (Tr and Orth), Graham M. Tytherleigh-Strong, FRCS (Tr and Orth), and Benjamin J. Ollivere, MD, FRCS (Tr and Orth) Objectives: Recent evidence to suggest that fixation of clavicle fractures yields better outcomes than conservative treatments has led to an increasing trend toward operative management. There is no evidence, however, to compare early fixation with delayed fixation for symptomatic patients before union. Design: Prospective comparative case series. Setting: Level 1 regional trauma center. Patients: Displaced clavicle fractures treated operatively in our institution during a 4-year period. Ninety-seven patients were included: 68 with early fixation and 29 delayed. Radiographic and clinical outcomes were available for all patients and scores were available for 62. Intervention: Early plate fixation (within 3 weeks) of displaced clavicle fractures compared with delayed (3 12 weeks) fixation of displaced clavicle fractures. Outcomes: Radiographic union, Oxford Shoulder Score, Quick- DASH, EQ5D, and a patient interview. Mean follow-up was to 30 months. Results: There were no statistically significant differences in age (P. 0.05), sex (P. 0.05), and energy of injury (P. 0.05) between the 2 groups. The mean QuickDASH was 8.9 early and 9.1 delayed (P, 0.05) and the Oxford Shoulder Score was 44.2 early and 43.9 delayed (P, 0.05). In the early fixation group, there were 5 wound healing complications, and 8 went on subsequently to have removal of prominent metalwork. In the delayed fixation group, 2 had wound healing complications and 4 required removal of prominent metalwork. There were no statistically significant differences in the EQ5D scores. Conclusion: Our series supports delayed fixation of symptomatic clavicle fractures as results do not differ from early fixation. Accepted for publication June 17, From the Cambridge Shoulder Unit, Addenbrooke s Hospital, Cambridge, United Kingdom. Presented at the Annual Meeting of the Orthopaedic Trauma Association, October 15, 2011, San Antonio, TX. The authors report no conflicts of interest. Reprints: Benjamin J. Ollivere, MD, FRCS, (Tr and Orth) Academic Department of Accident and Orthopaedic Surgery, Queens Medical Centre, Nottingham, UK ( ben.ollivere@nuh.nhs.uk). Copyright 2013 by Lippincott Williams & Wilkins Key Words: clavicle, fracture, fixation, outcomes Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence. (J Orthop Trauma 2014;28: ) INTRODUCTION Displaced clavicle fractures are a common injury occurring in up to 2.6% 1 of fracture patients. A consensus of opinion concerning the best treatment for these injuries has not yet been reached. Initial operative management of patients with open injuries, floating shoulders, multiple rib fractures, and those with compromised skin integrity is common practice and in the operative fixation of established nonunion. It is also common practice that displaced lateral third of clavicle fractures are treated operatively because of acromioclavicular joint and shoulder girdle involvement. Initial studies 2 4 comparing operative intervention to nonoperative treatment of middle third fractures established that good functional outcomes and acceptable union rates could be expected in most conservatively managed cases. Consequentially, middle third displaced clavicle fractures have been for the most part managed conservatively. More recent work has demonstrated high nonunion rates in some conservatively managed subgroups. 5 7 This coupled with a randomized controlled trial 8 showing improved functional outcomes after operative fixation has rekindled interest in early fixation. However, operative intervention carries with it risks of surgery, and reported complication rates reach 34%. 8 The current literature supports the assertion that some patients 5 7 will have a poor functional result after nonoperative treatment of their middle third clavicular fracture. Although primary plate fixation is a reliable technique for the treatment of displaced mid-shaft fractures of the clavicle, it is clear that many individuals with this injury have acceptable functional results with nonoperative treatment without exposure to risks of operative complications. Therefore, if delayed fixation provides results similar to those seen with primary fixation, a practice of selective delayed fixation may be justified. It is not clear at which stage those patients who will do poorly with conservative treatment become evident. With early regular follow-up, it may be possible to switch patients from conservative to operative fixation should their fractures fail nonoperative management. There is no current J Orthop Trauma Volume 28, Number 3, March

2 Das et al J Orthop Trauma Volume 28, Number 3, March 2014 evidence comparing the results of delayed fixation in those patients in whom symptoms of pain and clicking do not resolve after a short trial of conservative treatment with early operation, we sought in a prospective comparative series to establish what the expected success rate of a wait-and-see approach with delayed intervention in those patients who continue to be symptomatic. If functional results were similar between delayed and early fixation, the risks of surgery could be avoided for those who would do well with conservative treatment without compromising the functional results of those who would do badly. We therefore aimed to compare the results of early and delayed fixation for mid-shaft clavicle fractures in a prospective nonrandomized comparative series. Hypothesis Early fixation of clavicle fractures yields superior results to delayed fixation. PATIENTS AND METHODS After institutional review board approval, all patients sustaining a displaced mid-shaft clavicle fracture in our institution between August 2006 and May 2010 were eligible for inclusion in the study. Patients were prospectively reviewed as part of their care and enrolled into the followup study once the decision to operate (either early or delayed) had been made. Before enrollment in the study, all patients were clinically assessed by 1 of 3 consultant upper limb surgeons and counseled as to the risks and benefits of operative treatment. Patients with a 100% displaced middle third clavicle fracture and no contraindications to operative treatment were offered either operative or conservative treatment. Those electing for early fixation were enrolled into the early fixation group. Patients with open fractures were excluded from subsequent analyses as our practice remains to treat all of these operatively. Those patients not opting for early fixation, as part of their normal clinical care, were prospectively followed with serial (6 weeks or earlier at patients request) radiographs and clinical review until either fracture union or failed conservative treatment and subsequent operative intervention. Patients who became more symptomatic (with increasing pain or deformity), or those in whom shoulder symptoms (pain or painful clicking) failed to subside between clinic reviews to the extent that the patient was unable to progress their rehabilitation were then offered operative fixation. Crossover from conservative to operative management was at the patient s request. These patients were then enrolled into the study and constituted the delayed fixation group. Patients were included in this group who had fixation between 3 weeksand3months. Patients were all operated under the supervision of 1 of 3 consultant upper limb orthopaedic surgeons who reviewed the patient on each follow-up visit. method was selected by the operating surgeon according to the fracture configuration and soft tissue envelope. Operative fixation was undertaken according to AO principles, simple fractures were fixed with lag screw fixation and a superior aspect neutralization plate to obtain absolute stability. In multifragmentary fractures, fixation was achieved with a bridging plate restoring length alignment and rotation. All patients were operated on using standard aseptic technique and an infraclavicular approach. Patients undergoing delayed fracture fixation had similar surgery with intervening soft tissue removed and stable fixation. After surgery, all patients were given a sling for comfort and started an early active mobilization program, although resistance with the limb was avoided for 6 weeks postoperatively. Patients were prospectively followed with regular radiographs and clinical review (6 weekly or earlier at the patients or physiotherapists request until fracture union) and prospective patient clinical scoring. Patient scores for shoulder performance (Oxford Shoulder Score, QuickDASH score), quality of life (EQ5D), and participation (work and sporting activities) were completed at least 3 months after their final clinical review. Radiographs were reviewed by 2 independent observers, and clinic notes, accident and emergency records, and operative notes were reviewed as part of the study. Statistical analyses were undertaken using GraphPad Prism v5 (GraphPad Software Inc, La Jolla, CA). Statistical significance were taken to be a P, 0.05 in all cases. Parametric data were analyzed with a 2-tailed student t test and nonparametric data with Mann Whitney U test. Nominal data were analyzed using contingency tables and Fisher exact test. RESULTS There were 1211 clavicle fractures presented to our unit during the study period (Fig. 1). Of these, 654 were middle third clavicle fractures and 518 were displaced. We managed 450 of these conservatively and 68 with early fixation. Of the 450 conservatively managed fractures, 29 underwent delayed fixation. Therefore, between August 2006 and May 2010, 97 patients were managed with operative fixation for displaced middle third clavicular fractures. Sixty-eight of these were managed initially with operative fixation (early fixation) and 26 with delayed fixation group. The mean age of the patients at the time of injury was 38 years. There were 49 men and 48 women. There were no statistically significant differences in age (P. 0.05), sex (P. 0.05), and energy of injury (P. 0.05) between the 2 groups (Table 1). Outcomes were known for all patients, however, complete follow-up including all scores was available for 62 patients. All patients had attended their clinical follow-up, and data were available for at least 12 months after surgery; however, only 62 patients were available for interview at the time of the study. There were no differences in demographics (age, sex, and mechanism of injury) between those who did and those who did not attend. All fractures were middle third displaced clavicle fractures with at least 1 cm of shortening or displacement. Three patients sustained open clavicular fractures, all in the early fixation group. There were no open fractures in the delayed fixation group. All patients within the early fixation group underwent fixation within 3 weeks (median, 13; mean, 13; SD 8 days from injury to operation), where patients within the delayed Ó 2013 Lippincott Williams & Wilkins

3 J Orthop Trauma Volume 28, Number 3, March 2014 Operative Intervention in Clavicle Fractures FIGURE 1. Patient recruitment flow chart. fixation group, all underwent operative fixation between 3 and 12 weeks (median 40, mean 43, and SD 26 days from injury). There was a significant difference in elapsed time between injury and operation in the 2 groups (P, 0.001). Mean clinical follow-up was to 31 months (range, 12 52) after fixation. Thirty patients were fixed with absolute stability (lag screw or compression plate), the remainder with relative stability (bridge plating). The overall complication rate was 18.6% (cohort = 18/97, early n = 12/65, and delayed n = 6/29). Of these, there was 1% nonunion (cohort n = 1/97, early n = 1/65, and delayed n = 0/29) and 17% other complications (cohort n = 17/97, early n = 11/65, and delayed n = 6/29). These complications were 8% wound healing or infection (n = 8/97) and 9% suffering late symptomatic metalwork or painful scars (n = 9/97). There was no statistically significant difference in complication rates between the 2 groups of patients (P. 0.05) (Table 2). Radiographic union was achieved in an average of 21 weeks from surgery. There was no statistically significant difference between the 2 groups (P. 0.05). There were also no statistically significant differences in functional outcomes between subgroups (Table 3). The mean QuickDASH score at final follow-up was 8.9 in the early fixation group and 9.1 in the delayed fixation group (P, 0.05). The Oxford Shoulder score was 44.2 in the early fixation group and 43.9 in the delayed fixation group (P, 0.05). The 424 patients, who were successfully treated conservatively for their clavicle fractures, were all discharged from orthopaedic fracture clinic and none were reoperated within our own institution during the period of the study. There were no statistically significant differences in the EQ5D quality-of-life questionnaire or patients reported time to return to work after surgery in either group, but statistically different relative to time of injury (63 days vs. 41 days; P, 0.001). DISCUSSION The lack of statistically significant difference in any of the functional outcome measures, quality of life scores, or participation measures is the striking and most important TABLE 1. Patient Demographics Whole Cohort Early Delayed P N M:F 55:42 39:29 16: Age 38.1 (SD = 13.48) 37.4 (SD = 17.4) 41.2 (SD = 13.7).0.05 High energy 38% (n = 37) 35% (n = 24) 45% (n = 13).0.05 Open fractures N/A Ó 2013 Lippincott Williams & Wilkins 121

4 Das et al J Orthop Trauma Volume 28, Number 3, March 2014 TABLE 2. Complication Rates Total (n = 94) finding of this study. This finding adds evidence to our practice of selective early fixation, patients undergoing operative intervention for clavicle fractures between 3 and 12 weeks may be safely treated without exposure to excess complications. Although the surgery may be technically more challenging, we did not observe a higher complication rate in those patients undergoing delayed fixation. The evidence provided by the Canadian Orthopaedic Trauma Society 8 demonstrated improved Constant and DASH scores at all time points in 132 patients randomized to operative or nonoperative treatment for displaced mid-shaft clavicle fractures. These results have been confirmed by other randomized controlled trials examining a variety of fixation methods. 9,10 The results of our study do not conflict with these trials but suggest rather that delayed operative intervention does not lead to poor functional result. The findings of this study support selective fixation in patients who develop early symptoms which could indicate the development of a delayed or nonunion. Within our series, 8% of patients experienced an early complication and 9% required implant removal. Our complication rates, however, are similar to or lower than those reported in the literature This study does suffer from several confounders. As this is not a randomized or quasi-randomized trial, it is likely that there is significant selection bias on the part of both the patient and the surgeon. Counseling of patients was undertaken by the treating surgeon, and it is likely that patients with more severe injuries or higher shoulder demands will have been counseled toward the initial operation group. We do not have follow-up clinical scores or radiographic data for patients treated successfully conservatively. In addition, only 62 of 94 patients were available for final interview, although their outcomes were known, and it is possible that these patients had done especially well or poorly and consequently including them would have changed the results. It is therefore not possible to assert that conservative TABLE 3. Functional Outcome Measures Total Early (n = 65) Primary (n = 65) Delayed (n = 29) P Nonunion Wound healing/ infection Symptomatic metalwork/scars Total (18%) 6 (21%).0.05 Delayed (n = 29) P QuickDASH Oxford Shoulder EQ5D treatment yields similar functional results to operative based on the results of this series. In our series, those patients opting for the pragmatic wait and see approach with conservative treatment did not in any way compromise their subsequent operation. The functional outcomes were identical, and there was no significantly increased complication rate associated with delayed fixation. Although the current evidence base supports early operative intervention in displaced mid-shaft clavicular fractures; 8 11 in light of our findings, we would not advocate operative fixation in these clavicular fractures as a treatment modality of choice. The COTS study 8 demonstrates improved functional results in a very tightly controlled randomized controlled trial. The functional results for both of our cohorts were similar to those reported by the Canadian Orthopaedic Trauma Society. We have demonstrated that functional outcomes are similar with delayed fixation performed between 3 and 12 weeks of fracture. Given the relatively high complication rates associated with this procedure and in light of the findings of this study, we advocate early fixation only in those patients where there is a clear indication for operative treatment. Other patients may be treated conservatively in the first instance and undergo operative fixation at a later date if they fail conservative management. This is the first study to explicitly examine the practice of delayed early fixation for those whose symptoms have failed to subside with conservative management. Although it is most certainly possible that given more time the patients in our delayed fixation group would have gone on for their symptoms to resolve, it is equally possible that given the time interval (median 40 days) with no resolution of pain or fracture site mobility that these patients would have gone on to nonunion or delayed union. Our delayed fixation group constituted only 5.7% of all patients undergoing conservative treatment (Fig. 1), and in this study, there was no statistically significant difference in shoulder performance or quality-oflife scores between the early and delayed fixation groups; the final result was the same. It is important to remember when interpreting these results that the delayed fixation group had a mean intervention time of 7 weeks postinjury and is not generalizable to clavicular nonunion. There has been a single recent report of iatropathic brachial plexus injury after clavicle fracture fixation, 12 and this article raises the concern that later clavicle fixation may result in a higher rate of brachial plexus injury and recommends mobilization of tissue under the clavicle before fixation, although this is not a problem that we have experienced in our own practice and is rarely reported in the orthopaedic literature. We recommend nonoperative treatment other than in those patients with a clear indication for surgery. Careful clinical review and operating on only those whose symptoms fail to subside within the first few weeks of treatment will reduce over operation but, at the expense of a longer treatment episode, for those failing conservative treatment. It is not possible to say how many of those we treated with delayed early fixation would have gone on to nonunion. However, of those attempting conservative treatment only 6% failed conservative treatment at early review (n = 29/450). Given the not insignificant minor complication rates for this Ó 2013 Lippincott Williams & Wilkins

5 J Orthop Trauma Volume 28, Number 3, March 2014 Operative Intervention in Clavicle Fractures treatment and the similar functional results of early delayed fixation to early fixation, we continue to use this approach in our unit. Because of the inherent selection bias in this study, it is impossible to be completely assured that those patients with delayed intervention are indeed those who would do poorly without surgery, and although we know none of the 421 remaining conservatively managed patients underwent subsequent intervention in our own unit, we do not know if they did so further afield, as these patients have not been followed up as part of the study. A larger randomized controlled trial would be required to be completely confident. In light of the findings of this study and taking into account the inherent limitations, there does not appear to be a difference in complication rate or outcome scores between patients undergoing early or delayed fixation. This adds to the body of evidence surrounding clavicle fracture treatment and does suggest that even patients with indications for surgery may be treated conservatively without compromising later fixation if either the surgeon or the patient is uncertain about a policy of early fixation. REFERENCES 1. Postacchini F, Gumina S, De Santis P, et al. Epidemiology of clavicle fractures. J Shoulder Elbow Surg. 2002;11: Neer CS. Nonunion of the clavicle. JAMA. 1960;172: Nordqvist A, Petersson C. The incidence of fractures of the clavicle. Clin Orthop Relat Res. 1994;300: Stanley D, Norris SH. Recovery following fractures of the clavicle treated conservatively. Injury. 1988;19: Robinson CM. Fractures of the clavicle in the adult. Epidemiology and classification. J Bone Joint Surg Br. 1998;80: 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: McKee MD, Wild LM, Schemitsch EH. Midshaft malunions of the clavicle. J Bone Joint Surg Am. 2003;85: Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. JBoneJointSurgAm.2007;89: Judd DB, Pallis MP, Smith E, et al. Acute operative stabilization versus nonoperative management of clavicle fractures. Am J Orthop (Belle Mead NJ). 2007;38: Smekel V, Irenberger A, Struve P, et al. Elastic stable intramedullary nailing versus nonoperative treatment of midshaft clavicular fractures a randomized, controlled, clinical trial. J Orthop Trauma. 2009;23: Kulshrestha V, Roy T, Audige L. Operative versus nonoperative management of displaced midshaft clavicular fractures: a prospective cohort study. J Orthop Trauma. 2011;25: Jeyaseelan L, Singh VK, Ghosh S, et al. Iatropathic brachial plexus injury: a complication of delayed fixation of clavicle fractures. Bone Joint J. 2013;95-B: Ó 2013 Lippincott Williams & Wilkins 123

Comparison of Complication Rates of Intramedullary Pin Fixation Versus Plating of Midshaft Clavicle Fractures in an Active Duty Military Population

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