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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 5  |  Issue : 1  |  Page : 35-40

Can titanium elastic nails deliver a knockout punch against precontoured locking plates in handling displaced middle third clavicle fractures?


1 Department of Orthopaedics, Chaitra Hospital, Eluru, Andhra Pradesh, India
2 Department of Orthopaedics, NIMRA Institute of Medical Sciences, Vijayawada, Andhra Pradesh, India
3 Department of Orthopaedics, Golden Jubilee Hospital, Port Trust, Visakhapatnam, Andhra Pradesh, India
4 Department of Orthopaedics, Saisudha Hospital, Kakinada, Andhra Pradesh, India

Date of Submission05-Dec-2021
Date of Decision25-Dec-2021
Date of Acceptance18-Jan-2022
Date of Web Publication15-Mar-2022

Correspondence Address:
Jameer Shaik
Chaitra Hospital, Eluru - 534 002, Andhra Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jodp.jodp_36_21

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  Abstract 


Background: Plating is the gold standard for displaced middle third clavicle fractures, which holds true at least for comminuted fractures with a fair share of complications. For displaced fractures without comminution, intramedullary titanium elastic nailing system is an emerging option which claims similar success rates with fewer complications. There is a deficit in data pertaining to prospective trials supporting such claims which has propelled us to carry out this study. This study aims to compare the functional outcome and complication rates between precontoured locking plates and titanium elastic nails for displaced clavicle fractures. Materials and Methods: A prospective cohort study carried out on 56 patients with displaced clavicle fractures without comminution treated either by nailing (with open reduction through minimal incision at fracture site) or plating, and the results pertaining to their functional outcome and complication rates were compared. Results: Nottingham clavicle score and Constant Murley score were calculated at 6, 12, and 24 months along with comparison of complication rates. Conclusion: The functional outcome scores recorded significant differences at 6- and 12-month periods between the groups, which minimized at 24 months. Complication rates were significantly different between the groups. These results of functional outcome and complication rates point toward titanium nailing as an attractive alternative to plating for a comminuted displaced middle third clavicle fractures.

Keywords: Clavicle fractures, Cohen effect, Constant Murley score, Nottingham clavicle score, precontoured locking plates, titanium elastic nails


How to cite this article:
Shaik J, Paka VK, Pilaka RS, Murthy Talluri SS. Can titanium elastic nails deliver a knockout punch against precontoured locking plates in handling displaced middle third clavicle fractures?. J Orthop Dis Traumatol 2022;5:35-40

How to cite this URL:
Shaik J, Paka VK, Pilaka RS, Murthy Talluri SS. Can titanium elastic nails deliver a knockout punch against precontoured locking plates in handling displaced middle third clavicle fractures?. J Orthop Dis Traumatol [serial online] 2022 [cited 2022 May 24];5:35-40. Available from: https://www.jodt.org/text.asp?2022/5/1/35/339681




  Introduction Top


Clavicle fracture accounts for 2.6%–4% of all adult fractures. Conservative management is better suited for undisplaced fractures.[1] Displaced midshaft clavicle fractures (DMCF) (displacement more than 100% of its width) are associated with 15%–20% of nonunion when manag ed conservatively.[2] A 2-cm shortening (overlap) of fracture is associated with higher incidence of nonunion, poor shoulder function, and frequent pain.[3],[4] Such displacement and shortening require surgical management[5] to restore bone length and improve the quality of outcome.[6],[7]

Comminution in the clavicle fracture warrants the use of locking plate.[8] The current gold standard for the treatment for DMCFs is plating.[9] Titanium elastic nailing system (TENS) is the frequently used intramedullary device for noncomminuted clavicle fractures. There is a deficit in data pertaining to prospective comparison of performance of precontoured plates with titanium nails. This prospective study aims to compare and analyze the functional results and overall complication trends of precontoured plates and titanium nails in managing DMCFs. The study design incorporates a two-tailed testing model (bidirectional) which is proved to be an efficient tool of comparison of treating options.


  Materials and Methods Top


Study design

This is a nonrandomized, prospective cohort study with level II evidence (therapeutic) performed on patients with DMCFs admitted from March 2016 to October 2018 in our hospital. Its sole purpose was to compare the functional outcome and complication rates of precontoured plates with that of TENS. Ethical approval for the study was taken from the ethics committee of the institute before the initiation of the study.

Patients aged between 18 and 50 years presenting with middle third clavicle fractures with displacement >100% of the width and/or shortening >2 cm were included in the study. Patients with open fractures, lateral and medial end fractures, comminuted, wedge, segmental, or pathological fractures, and those associated with ipsilateral ribs, scapula and upper limb fractures, bilateral presentation and with neurovascular deficit were excluded from the study.

Patients were allowed to choose among conservative treatment, surgical plating, or nailing after being explained the pros and cons of each option based on the available literature. Seventy-two patients satisfied the inclusion criteria. Sixteen patients who opted for conservative treatment were excluded from this study, leaving us with a total of 56 patients. Preliminary evaluation was performed, and informed consent was taken from all patients. Patients were operated under general anesthesia with proper antibiotic prophylaxis.

Operative technique - plating group

The fracture was approached with an anterior slightly curved incision over clavicle centering over the fracture site [Figure 1]a and [Figure 1]b. A 3.5-mm precontoured clavicle locking plate (PCLP) of appropriate length was applied on the superior surface of the clavicle.
Figure 1: (a and b) Intraoperative images of precontoured plate applied to the superior surface of clavicle after proper surgical exposure. (c) Intraoperative images of a titanium elastic nail being passed through medial end of clavicle (yellow arrow) after open reduction performed through small incision over fracture site (blue arrows)

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Operative technique - titanium elastic nailing system group

A 15-mm long incision was made at the medial end of the clavicle. Entry point was made in the anterior cortex at about 15 mm lateral to the medial end of the clavicle [Figure 1]c. A second incision was over the fracture site to aid its reduction (we preferred open reduction to closed to minimize surgical time, effort, c arm exposure, and undue soft tissue disruption at fracture site). Medial end of the nail was bent to 90° (to prevent medial migration and facilitate extraction) and the remaining protruding part was removed.

Patients were advised sling support for 2 weeks. Pendular exercises were advised in the 1st week, passive range of motion exercises in the 2nd week, and active range of motion exercises from the 3rd week. Strengthening exercises were started from the 6th week. Follow-ups were programmed at the end of 3 and 6 weeks and 3, 6, 12, and 24 months. At each follow-up, check X-rays [Figure 2] were taken along with the assessment of functional status, surgical site for implant prominence, and any signs of infection.
Figure 2: (a-d) Preoperative and postoperative radiographic images of patient treated with precontoured plates. (e-j) Preoperative and postoperative radiographic images of patient treated with titanium elastic nails

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The primary outcomes of the study were functional outcomes assessed using Nottingham clavicle score (NCS) and Constant Murley (CM) score measured at 6, 12, and 24 months postsurgery. Secondary outcomes measured were the complication rates.

Sample size

A priori sample size calculation was done using the study by Hendrik et al. (2018) which helped in estimating the sample size of 28 patients in each group to attain 80% power of the study with a (alpha) significance of 0.05. A 10% inflation of minimum sample size was considered to account for potential dropouts in both the groups. A minimum difference of 10 points in NCS/CM score between two groups was considered to be clinically significant.

Data analysis

Data analysis was performed using Data analysis was performed using IBM SPSS Statistics for Windows, version V27.0 (IBM corp. Released 2020, Armonk, New York, USA). Levene's test was used to assess equality of variances. Parametric parameters were assessed using an unpaired t-test. Nonparametric parameters were tested using Mann–Whitney U-test and Chi-square test. CM score and NCS were assessed using t-test, while complication rates assessment was performed using Chi-square test.


  Results Top


A total of 56 patients were included in the study and categorized based on their choice of management option (27 - precontoured plating and 29 - titanium elastic nailing). There was no notable difference in the general characteristics between the two groups. Average age of presentation in the plating and nailing was 33.8 and 31.3 years, respectively. In the plating group, 22 were male and 5 were female. In the nailing group, 21 were male and 8 were female. Right side involvement was noticed in 15 patients of plating group and 19 patients of nailing group while 12 patients of plating group and 10 patients of nailing group presented with left side involvement. Dominant side involvement was 50% (28 out of 56). Most common mode of injury in both the groups was road traffic accident (RTA) with 21 out of 27 in Precontoured clavicle locking plate (PCLP) group and 20 out of 29 in TENS group having acquired the injury due to RTA.

Follow-up duration in the PCLP group patients ranged between 22 and 40 months (median 27 months) and in the TENS group between 20 and 32 months (median 24 months). Functional evaluation was done using NC scoring system and CM score [Table 1].
Table 1: Nottingham clavicle score and Constant Murley score mean values recorded at follow-up of 6, 12, and 24 months

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NCSs recorded at the end of 6, 12, and 24 months for PCLP and TENS groups were 78.14, 82.33, and 94.72 and 90.86, 94.51, and 98.23, respectively. Constant scores taken at similar intervals were 80.68, 85.83, and 96.22 for the PCLP group and 90.46, 96.73, and 98.03 for the TENS group. An initial difference of 10 or more noted at 6- and 12-month period in the CM score/NCS between groups was statistically significant. This difference may be attributed to the wound-related problems that were resolved during later stages, leading to their disappearance at the end of the 2-year period. The difference in CM score and NCS noted at the end of 2 years of follow-up between the groups was not statistically significant, indicating that the functional outcome was just about the same in both groups.

Complications

Surgical site infection was noticed in 5 patients (18.51%) in the PCLP group and in 1 patient (3.44%) in the TENS group [Table 2]. Infection [Figure 3]a was controlled in 3 patients [Case 1, 2, and 3 in [Table 3]] in the PCLP group and the only one patient [Case 6 in [Table 3]] in the TENS group in 7–10 days through oral antibiotic use and proper wound care. In the remaining two patients [Case 4 and 5 in [Table 3]] of PCLP group with wound breakdown [Figure 3]b exposing the implant partially, implant removal and debridement was necessary and antibiotics were administered as per culture and sensitivity reports. Both these wounds healed but with bad scars.
Figure 3: (a) Surgical site infection with satellite lesion which is the prime concern both to the patient as well the surgeon due to the robust nature of the implant. (b) Wound breakdown with implant exposure in another patient that necessitated implant removal and debridement with proper antibiotic coverage

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Table 2: List of complication in the two treatment groups (locking plate and titanium nail group)

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Table 3: List of various complications encountered over the course of 2 years in both groups, along with the treatment provided to overcome them

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Eight patients (29.62%) in the PCLP group and six patients (20.68%) in the TENS group had implant irritation which caused occasional mild discomfort which was well tolerated. In the TENS group, pin migration was observed in 1 case (3.44%) at 3 months which was then removed, and no further intervention was needed as the fracture was united. Two patients (6.89%) in the TENS group complained of vertically moving bent–nail–tip suggesting rotation of tens inside the clavicle, with no visible migration. All patients, in both the groups, achieved union by the end of 6 months. There were no reported cases of malunion/nonunion in either of the groups.

Elective implant removal was done in 15 patients (55.55%) of the plating group at 9–20 months (average 13 months) and 22 patients (75.86%) of TENS group at 6–13 months (average 7 months). 10 patients (37.03%) in the plating group and 6 patients (20.68%) in the nailing group refused implant removal.


  Discussion Top


Management of clavicle fractures through rational approach requires clear knowledge about factors, which predict the outcome of management and exclude the chances of nonunion.[10] The present prospective study is aimed at comparison of union rates and functional outcome complications related to the management of displaced middle third noncomminuted clavicle fractures using either TENS or PCLP. Plating is better suited for the management of comminuted fractures of the middle third of the clavicle but is overkill for relatively simpler fracture patterns due to associated complications. Current trend has seen a rising use of intramedullary devices such as elastic nails with better acceptance than plating. Our study results are in sync with this trend and favor elastic nailing owing to its lower complication rates, with similar quality of results comparable to plating in the long run. Our study has shown results in favor of elastic nailing owing to its lower complication rates, with similar quality of results comparable to plating in the long run.

This present prospective study has maintained near-identical demographic features in both the treatment groups. Union was achieved in all patients of PCLP and TENS groups by the end of 6 months. King et al.[11] (2019) reported 100% union at the end of 12-month period postsurgery. Walz et al.[12] in their study which included 35 patients pertaining to use of only elastic nailing for clavicle fractures concluded that TENS provides good union rates. Union rates achieved in this study were better than most of the earlier studies on DMCF. Faster healing rates for TENS relative to PCLP were reported in studies by Wu et al.,[13] Mueller et al.,[14] Hartmann et al.,[15] and Liu et al.[16]

Recently introduced NCS and conventionally used Constant score were considered in the evaluation of function of patients included in this study. The mean difference in the NCS between the two groups at 6, 12, and 24 months were 12.72, 12.18, and 3.51 which was similar to the difference noted in a study by King et al. (2019). 12-month Nottingham clavicle score (NCS) score of our study was consistent with most of the major studies (Jubel et al. - 97.9, Walz et al. - 98.3, and Mueller et al. 95). Least CS score reported for TENS group at 1-year period was 81 by Kettler et al. (2007) in their study on 87 patients on use of TENS for Displaced midshaft clavicle fractures (DMCF). Kettler et al. further stated that TENS is a procedure associated with just minor risks and complications. In our study, CS scores and NCSs were similar at the end of 2 years, but a statistical difference was noted at 6 and 12 months with better reports being noticed in the TENS group. Surgical site infection and wound breakdown may have led to relatively poor CS score and NCS in plating group compared to TENS group. Fuglesang et al.[17] found no statistically significant difference in the scores of PCLP and TENS groups at 1-year follow-up. King et al. suggested that both PCLP and TENS are equally effective in the management of DMCF with a Cohen effect better reported for TENS group. Gupta et al.,[18] 2017 reported that CS scores were similar in both nailing and plating group at the end of 1 year in spite of initial differences noted between plating and nailing group before 1 year.

Nails inserted from the medial end fared well than those inserted from lateral end with reference to CS scores. This tendency could be a result of more shoulder dysfunction seen when lateral entry point is used. This view is also supported by Paul et al. who reported that disabilities of the arm, shoulder and hand (DASH) scores were superior when nails were introduced using a medial entry point compared to lateral entry.

Overall complication rates were 34.48% in the TENS group and 48.14% in the PCLP group. A 14% difference in the complication rates was noticed between these groups that were statistically significant. Böstman et al.[19] reported high complication rates (soft tissue infection, implant failure, nonunion, and poor cosmetic appearance of the incision) with plate fixation. Complication rates of plating were higher than in the TENS group and are in accordance with the studies reported by Kadakia et al.[20] Zeng et al.,[8] Sharma et al. (2016), and Gao et al.[21] Surgical site infection was noticed in 5 patients (18.51%) in the plating group and 1 patient (3.44%) in the nailing group. Pooled incidence of infection for TENS was only 2% in a systematic review of (Hoogervorst et al., 2020). Complications reported by Lenza et al.[22] in 2013 were 9% infection rate, 14% skin and nerve problems, and 8% implant irritation resulting in implant removal. Danish Fracture Database indicated that one of the six patients (16.66%) would end up with a need for a secondary procedure in plating (Ilija Ban et al., 2016). Implant-related irritation was observed in 29.62% of the PCLP group and 20.68% of the TENS group. Hardware failure reported for TENS was 4% in the same review. Plating is associated with a higher rate of infection, refracture.[23] In the TENS group, pin migration was observed in 1 case (3.44%); and two patients (6.89%) complained of a vertically moving bent–nail–tip, suggesting rotation of TENS inside the clavicle, with no visible migration.

Less intraoperative time and blood loss, smaller size of the incision, shorter duration of hospitalization, fewer wound-related complications with superior functional outcome, and easy implant removal are the hallmarks of intramedullary nailing.[24] Shorter healing time with early functional recovery supplemented by better cosmoses enhance/ensure patient satisfaction (Chen et al., 2012). Cosmetic satisfaction of the patients was more for the nailing group in a study by Chen et al. Most of the existing studies reported similar faster healing with nailing[25],[26],[27] (Gao et al., Kadakia et al., and Jain et al.). Fewer wound-related complications can be attributed to minimal soft tissue dissection with preservation of soft tissue envelope and vascularity.

Absence of a randomized control group and smaller number of patients operated at a single center are the main limitations of this study. Preselection bias arising due to the patient's liberty over choice of implant disallowed randomization. Randomized control trials with a larger sample size are further needed to establish the superiority of titanium elastic nails as an impressive alternate treatment modality to plating of these fractures.


  Conclusion Top


Cosmetic appearance and patient satisfaction related to surgical sites were better in the nailing group. Open reduction of fracture site brings a technical ease to nailing compared to closed reduction and percutaneous nailing. It allows for reduced duration of surgery and minimal radiation exposure. Overall, TENS seems to perform better in the short run than plate, and if complications such as skin irritation are avoided through proper positioning of nail tip, there is a high propensity for TENS to overtake plating and deliver a knockout punch as the new champion in managing displaced middle third noncomminuted clavicle fractures.

To establish concrete evidence in support of the role of titanium nails in managing clavicle fractures, there is a future need of randomized controlled trials in that direction. We advocate the use of clavicle-specific scorings such as the NCS for assessment of pain and disability in all studies related to clavicle. We recommend the use of TENS through open reduction technique in management of noncomminuted displaced mid third clavicle shaft fractures.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Wild LM, Potter J. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg 2006;88-A:35-40.  Back to cited text no. 7
    
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Zeng L, Wei H, Liu Y, Zhang W, Pan Y, Zhang W, et al. Titanium Elastic Nail (TEN) versus reconstruction plate repair of midshaft clavicular fractures: A finite element study. PLoS One 2015;10:e0126131.  Back to cited text no. 8
    
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Virtanen KJ, Remes V, Pajarinen J, Savolainen V, Björkenheim JM, Paavola M. Sling compared with plate osteosynthesis for treatment of displaced midshaft clavicular fractures: A randomized clinical trial. J Bone Joint Surg Am 2012;94:1546-53.  Back to cited text no. 10
    
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Mueller M, Rangger C, Striepens N, Burger C. Minimally invasive intramedullary nailing of midshaft clavicular fractures using titanium elastic nails. J Trauma 2008;64:1528-34.  Back to cited text no. 14
    
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Fuglesang HF, Flugsrud GB, Randsborg PH, Oord P, Benth JŠ, Utvåg SE. Plate fixation versus intramedullary nailing of completely displaced midshaft fractures of the clavicle: A prospective randomised controlled trial. Bone Joint J 2017;99-B: 1095-101.  Back to cited text no. 17
    
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