Comparison of Patient Reported Outcomes Following Clavicle Operative Fixation Using Supraclavicular Nerve Sparing and Supraclavi

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Comparison of patient reported outcomes following clavicle operative ﬁxation using supraclavicular nerve sparing and supraclavicular nerve sacriﬁcing techniques– A cohort study

∗ Dawei Huang a, Yi Deng a,b, , Jizhou Cheng a,b, Yi Ren Bong a, Matthew Schwass a,

Igor Policinski a a Department of Orthopaedic Surgery, Canberra Hospital, Yamba Drive, Garran, ACT 2605, Australia b Trauma and Orthopaedic Research Unit, Canberra Hospital and Australian National University Medical School, Building 6, Level 1, Canberra Hospital, Yamba Drive, Garran, ACT 2605, Australia

a r t i c l e i n f o a b s t r a c t

Article history: Introduction: Supraclavicular nerve injury is one of the common complications after clavicle open re- Received 3 August 2020 duction internal ﬁxation (ORIF) affecting up to 55% of patients. There is debate about whether sparing

Revised 26 October 2020 supraclavicular nerves improves functional outcomes and patient satisfaction. The purpose of this study Accepted 26 October 2020 was to compare numbness, patient-reported outcomes and surgical time in patients undergoing clavicle Available online xxx ORIF using supraclavicular nerve sparing and supraclavicular nerve sacriﬁcing techniques.

Keywords: Patients and methods: We conducted a retrospective cohort study with prospective survey of 108 patients Clavicle with clavicular fractures treated with ORIF at a level 1 trauma centre. Patients were divided into two Fracture groups: 1) ORIF with supraclavicular nerve sparing techniques and 2) ORIF with supraclavicular nerve Supraclavicular nerve

Nerve sparing sacrificing techniques. Questionnaires were conducted and subjective numbness around supraclavicular Patient reported outcomes nerve distribution was our primary outcome measure. Secondary outcome measures included the Quick Disability of the Arm, Shoulder and Hand (QuickDASH) score, a numeric rating scale for pain and satisfaction with treatment and surgical time. Results: An overall response rate of 92% was achieved with an average follow-up of 16 months. There were 20 patients in the supraclavicular nerve sparing group and 79 patients in the supraclavicular nerve sacrificing group. 76% of all patients experienced numbness post-operatively and 91% of these patients experienced persistent numbness at final follow-up. There was no significant difference between the groups for age, gender, time to follow-up and mechanism of injury. Patients in the supraclavicular nerve sparing group had significantly less numbness at final follow-up (35% vs 86%, P < 0.001; OR = 0.21 95%CI 0.11- 0.40). There was no significant difference in the QuickDASH score nor the NRS for pain and function. Sparing supraclavicular nerves did not result in a significantly longer operation. Conclusions: Our study demonstrates that identification and protection of the supraclavicular nerves result in significantly less numbness following clavicle ORIF but does not affect patient reported functional outcomes. ©2020 Elsevier Ltd. All rights reserved.

Introduction racic outlet syndrome [2, 3] . Due to improvements in surgical fixation techniques and lower non-union and malunion rates [4, 5] , Clavicle fractures are one of the most common fractures to many surgeons are choosing to manage displaced clavicular frac- present for treatment and account for 3% of all fractures [1] . Histor- tures with operative fixation [6] . Various operative fixation tech- ically, the management has been non-operative, but the outcomes niques have been described, including intramedullary nails and have not always been positive. Non-operative treatment has re- open reduction and internal fixation (ORIF) with plate osteosynthe- sulted in various complications including pain, malunions and tho- sis [7] . This is usually done through either a vertical or a horizontal incision and dissection down to the clavicle. Either approach can potentially cause damage to the supraclavicular nerves [8] , with ∗ Corresponding author. studies reporting numbness in up to 55% of all patients [9, 10] . E-mail address: [email protected] (Y. Deng).

Please cite this article as: D. Huang, Y. Deng, J. Cheng et al., Comparison of patient reported outcomes following clavicle operative ﬁxation using supraclavicular nerve sparing and supraclavicular nerve sacriﬁcing techniques–A cohort study, Injury, https://doi.org/10. 1016/j.injury.2020.10.100 ARTICLE IN PRESS JID: JINJ [m5G; October 29, 2020;8:59 ]

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The supraclavicular nerves are a group of 2 to 3 cutaneous and closed in layers. Patients were followed up in the outpatient nerves originating from the superficial cervical plexus (C3 and C4). fracture clinic and gentle range of motion was commenced from 2 They course over the clavicle at variable distances from clinically weeks and strengthening from 6 weeks if clinical and radiographic appreciable landmarks [11] , which can make identifying them dif- union had been achieved. ficult intra-operatively. The supraclavicular nerves supply the skin We conducted a prospective questionnaire for each patient via over the clavicle, medial shoulder and the anterior chest wall, telephone. Our primary outcome measure was whether patients down to the breast [12] . Damage to these nerves can result in had subjective numbness around the surgical site post-operatively. numbness and paraesthesia to a large region of the chest and Secondary outcomes included the Quick Disability of the Arm, shoulder [13] . This could be potentially more significant in females, Shoulder and Hand (QuickDASH) score, patient reported pain and as it can affect the sensation of the breast and be bothersome with satisfaction with their treatment using a Numeric Rating Scale shoulder-strap type clothing [14] . Furthermore, damage can result (NRS) and surgical time. The QuickDASH score is a validated tool in painful neuroma formation [15] . It is therefore imperative to for the assessment of upper limb pain and function. It is an ab- identify and preserve these nerves during any surgical approach to breviated version of the Disability of the Arm, Shoulder and Hand the clavicle. There is debate amongst surgeons about whether this score but has been validated for use in the clinical setting [18, 19] . step should be done, as some surgeons do not believe it changes The scores range from 0-100, with 0 being the best and 100 being patient outcomes and increases surgical time, or that they can be the worst. The NRS for pain ranges from 0-10 with 0 being no pain sacrificed if necessary [7] . and 10 being the worst pain ever possible [20] and the NRS for sat- Therefore, the purpose of our study was to compare the differ- isfaction ranges from 0-10 with 0 being completely dissatisfied and ences in subjective numbness around the surgical site, long-term 10 perfectly satisfied with their treatment outcome [21] . patient reported outcomes and operative time in patients who had Ethics approval was granted by the Ethics Committee (reference ORIF of clavicle fractures using either supraclavicular nerve sparing number: 2020.LRE.0 0 020). Informed consent was obtained at the or supraclavicular nerve sacrificing techniques. Our secondary aims time of conducting the questionnaires. were to describe the epidemiology of clavicle fractures and deter- Data analysis was conducted using SPSS 22 (IBM, USA). Descrip- mine whether gender affects subjective numbness. We hypothe- tive statistics, means, frequencies and percentages were used to sised that if the supraclavicular nerves are spared, patients would summarize patient demographics. Independent t-tests were used experience less numbness, better patient-reported outcomes and to compare means for continuous variables and Fisher’s exact tests that it would not result in a longer operation compared to sacrific- for categorical variables. A binary logistic regression analysis was ing them. used to calculate the odds-ratio for post-operative numbness and a 95% confidence interval was reported. A P -value of < 0.05 was Patients and methods deemed statistically significant.

We conducted a retrospective cohort study with prospective Results survey of adults who had operative fixation for acute, displaced diaphyseal clavicle fractures (OTA/AO 15-2A, -2B and -2C) at a single, A total of 116 patients with diaphyseal clavicle fractures were tertiary level trauma centre – [16] . We included patients who were treated with ORIF at our institution over the 24-month period. 18 years of age or older, had ORIF with plate osteosynthesis and We excluded six patients with ipsilateral upper limb injuries and had definitive fixation within 14 days of injury. We excluded pa- two patients with a previous clavicle fracture. Therefore, 108 patients with open fractures, ipsilateral upper limb fractures or pre- tients were eligible for our study. A further 9 patients were lost to existing conditions, previous clavicular fractures, revision operative follow-up. The remaining 99 patients responded to our question- fixation, operative fixation for non-union and those lost to follow- naires, which represents a 92% response rate. The supraclavicular up. nerve sparing group had 20 patients and the supraclavicular nerve We retrospectively identified eligible patients using our elec- sacrificing group had 79 patients ( Fig. 2 ). tronic patient database over a consecutive 24-month period (July The mean age at fracture was 33 years of age (18 –69 years) 2017 –June 2019). Based on previous studies measuring rates of and 65% were less than 40 years of age. 95 patients were male numbness following clavicle operative fixation ranging from 6-55% (88%) and 13 were female (12%). The most common mechanism [9, 17] , a power calculation showed that a total of 16 patients in of injury was falling from a pushbike (n = 36) followed by other each group was required to have a power of 90%, with alpha set sports injuries (n = 24). The mean time to follow-up was 16 at 0.05. Demographic data and mechanism of injury was obtained months (6 –27 months). There were no significant differences from medical records. We divided our patients into two groups – in any of the demographic variables between the two groups supraclavicular nerve sparing and supraclavicular nerve sacrificing ( Table 1 ). groups, based on known surgeon preferences and a retrospective Overall, patients in both groups had excellent patient reported review of operation reports. outcomes, had very little pain and were very satisfied at an aver- The surgical technique between the two groups were identical, age follow up of 16 months after surgery. The mean QuickDASH except for the superficial dissection step. The patient was placed score was 4.7 ±0.4. The mean NRS for pain was 1.0 ±0.1 and NRS supine or sat upright 20 o on a radiolucent operating table. The pa- for function was 8.9 ±0.2. 75 patients (76%) reported post-operative tient was prepped and draped in a sterile fashion and prophylactic numbness after surgery and 69 (91%) of these patients had per- antibiotics were given prior to the skin incision. A direct anterior sistent numbness at an average of 16 months after surgery. Fe- approach to the clavicle shaft was utilised. Superficial dissection males had lower rates of numbness compared to males (55% vs through the subcutaneous tissues is performed. In the supraclav- 78%; P = 0.08) but the numbness tended to bother females more icular nerve sparing group, the surgeon identified, dissected and than males (22% vs 10%; P = 0.20). However, these differences were protected the supraclavicular nerves ( Fig. 1 A and B). This step was not statistically significant. omitted in the supraclavicular nerve sacrificing group. The incision Patients in the supraclavicular nerve sparing group experienced was deepened through the platysma muscle and the periosteum significantly lower rates of anterior chest wall numbness com- was stripped. The fracture was reduced, and a superior plate was pared to the supraclavicular nerve sacrificing group (35% vs 86%, applied for fracture stabilization. The final fracture position was P < 0.001; OR = 0.21 95%CI 0.11-0.40). Furthermore, patients in checked with an image intensifier. The wound was then irrigated the supraclavicular nerve sparing group also had better Quick-

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Fig. 1. (A and B) Intraoperative images demonstrating supraclavicular nerves (arrowheads) that have been identiﬁed and spared as part of the surgical approach, overlying a ﬁxation plate.

Total clavicle fractures managed with ORIF n = 116 Excluded: Ipsilateral upper limb injury (n = 6) Previous clavicle fracture (n = 2) Total eligible paents n = 108

SCN sparing group SCN sacriﬁcing group n = 20 n = 88 Lost to follow up Lost to follow up n= 0 n= 9

Final SCN sparing group Final SCN sacriﬁcing group n = 20 (100% response) n = 79 (89% response)

Fig. 2. Flow diagram of patient eligibility, selection and responses. SCN = supraclavicular nerve.

Table 1 Patient demographics, surgical time and mechanism of injury.

Overall ( n = 108) SCN Sparing ( n = 20) SCN Sacriﬁcing ( n = 88) P -value

Age 34.4 ±14.1 ∗ 30.3 ±2.4 ∗∗ 35.3 ±1.6 ∗∗ 0.149 Gender 13F 93M 4F 18M 9F 77M 0.255 Time to follow-up (months) 16.0 ±6.3 ∗ 17.2 ±1.7 ∗∗ 15.6 ±0.7 ∗∗ 0.344 Surgical time (mins) 59.3 ±15.9 ∗ 63.1 ±3.8 ∗∗ 58.4 ±1.7 ∗∗ 0.234 Mechanism of injury 0.443 Pushbike accident 36 4 32 Sports related injury 24 4 20 Motorbike accident 21 5 16 Skiing injury 11 4 7 Motor vehicle accident 4 1 3 Other 12 2 10

Note: ∗ mean ±SD, ∗∗mean ±SEM; SCN = supraclavicular nerve

DASH scores (3.2 ±0.9 vs 5.1 ±0.5; P = 0.09), less pain (0.8 ±0.2 Discussion vs 1.1 ±0.1; P = 0.08) and greater satisfaction (9.2 ±0.3 vs 8.8 ±0; P = 0.52) on NRS compared to the supraclavicular nerve sacrificing Clavicle fractures remain one of the most common fractures group, however, these were not statistically significant ( Table 2 ). managed by orthopaedic surgeons. One of the most common com- We also found no significant difference between operative time plications following clavicle operative fixation is numbness in the between the supraclavicular nerve sparing and sacrificing groups distribution of the supraclavicular nerves [22] . Some surgeons rec- (63.1 ±3.8mins vs 58.4 ±1.7mins; P = 0.23) ( Table 1 ). A subgroup ommend routine identification and protection of these cutaneous analysis of patients with greater than 12 months of follow-up nerves in order to avoid this complication but other surgeons do ( n = 66) demonstrated significantly lower rates of anterior chest not believe it is necessary and can be sacrificed if required [7] . wall numbness in the supraclavicular nerve sparing group, com- There have not been any studies to our knowledge comparing pared to the supraclavicular nerve sacrificing group (29% vs 81%, P nerve sparing and nerve sacrificing techniques for horizontal in- < 0.001; OR = 0.01 95%CI 0.03-0.36). cisions. One study has been done to demonstrate that vertical in-

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Table 2 Patient reported outcomes.

Overall (n = 99) SCN Sparing ( n = 20) SCN Sacriﬁcing ( n = 79) P -value

Numbness 75 (76%) 7 (35%) 67 (86%) < 0.001 QuickDASH 4.7 ±4.4 ∗ 3.2 ±0.9 ∗∗ 5.1 ±0.5 ∗∗ 0.09 NRS for pain 1.0 ±1.1 ∗ 0.8 ±0.2 ∗∗ 1.1 ±0.1 ∗∗ 0.08 NRS for satisfaction 8.9 ±1.9 ∗ 9.2 ±0.3 ∗∗ 8.8 ±0.2 ∗∗ 0.52

Note: ∗ mean ±SD, ∗∗mean ±SEM; SCN = supraclavicular nerve cisions have lower rates of numbness compared to horizontal inci- conducted over the telephone. This could be a potential source sions, likely due to the preservation of the supraclavicular nerves of error as the QuickDASH tool has not been validated for tele- [14] but more recent studies have not been able to show this dif- phone use. However, studies have demonstrated that other func- ference [8, 23] . tional assessment questionnaires have similar results when admin- We have demonstrated in our study that the patient reported istered over the phone compared to a paper form [26, 27] . Our min- function, pain and satisfaction with treatment were all excellent imum follow-up was 6 months so we would not have been able following operative fixation of displaced clavicle shaft fractures. to identify any differences in the early post-operative period, es- The overall QuickDASH scores at an average of 16 months is 4.7, pecially as the outcomes were so good at the time of the survey. meaning most patients had near-normal functional outcomes. This We also did not assess any objective measures such as two-point is slightly better than previously reported DASH scores of 11.8 at discrimination and area of numbness. These are two potential ar- > 12 month follow up [22] . The mean NRS reported by the whole eas of future research. A larger, prospective cohort study or ran- study cohort for pain was 1.0 and for satisfaction was 8.9 again domised controlled trial powered adequately for detection of dif- demonstrating that operative fixation yields excellent long-term ferences in QuickDASH or other patient reported outcomes would results. These are comparable with previous studies [24] . The ma- also be highly informative. jority of clavicle fractures tend to occur in young, healthy patients participating in recreational activities such as cycling and sports, Conclusions therefore we need to minimize the risks of surgery in order to achieve optimal long-term patient outcomes. We have demonstrated that the majority of patients still expe- One of the most common complaints after surgery is numb- rience anterior chest wall numbness over 1 year following opera- ness around the incisional site and in the distribution of the supr- tive fixation of clavicle fractures. A supraclavicular nerve sparing aclavicular nerves. We found that 76% of all patients experienced technique can be used to minimize this complication, without a numbness following operative fixation of clavicle fractures and 91% significant increase in operative time. However, we were unable to of these patients had persisting numbness after an average of 16 demonstrate any significant improvement in functional outcomes months. This is much higher than previously reported rates rang- and satisfaction from supraclavicular nerve sparing techniques. ing from 6-55% [9, 17] . Our study shows that patients experience almost a three-fold reduction in the incidence of post-operative Ethical approval numbness (35% vs 86%, P < 0.001; OR = 0.21 95%CI 0.11-0.40) when the supraclavicular nerves are spared and these differences persist Ethics approval was granted by the Australian Capital Terri- past 12 months (29% vs 81%, P < 0.001; OR = 0.01 95%CI 0.03-0.36). tory Health Human Research Ethics Committee (reference number: Interestingly, in certain patients, nerve function seems to improve 2020.LRE.0 0 020). Informed consent was obtained at the time of regardless of whether the nerves are spared or sacrificed during conducting the questionnaires. the surgical approach. This can be explained by collateral rein- Declaration of Competing Interest nervation by the remaining axons from the other supraclavicular nerves [25] , as it is unlikely all three branches are divided in one None procedure. 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