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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 5  |  Issue : 1  |  Page : 41-45

Does operative management provide better outcome in displaced mid-shaft clavicle fractures? A randomized control study


Department of Orthopaedics, MGM Institute of Health Sciences, MGM Medical College, Navi Mumbai, Maharashtra, India

Date of Submission10-Dec-2021
Date of Decision04-Jan-2022
Date of Acceptance05-Jan-2022
Date of Web Publication15-Mar-2022

Correspondence Address:
Harsh Kotecha
Department of Orthopaedics, MGM Institute of Health Sciences, MGM Medical College, Kamothe, Navi Mumbai - 410 209, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jodp.jodp_41_21

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  Abstract 


Background: Mid-shaft clavicle fracture management has been inclined more toward osteosynthesis in recent times for better functional outcomes. The aim of the study was to find out does operative management in displaced mid-shaft clavicle fractures provide better outcomes than conservative? Materials and Methods: The randomized trial was conducted between December 2017 and July 2019 at a tertiary trauma center on 50 consecutive patients with displaced mid-shaft clavicle fracture. The inclusion criteria included age between 16 and 60 with acute isolated closed displaced mid-shaft clavicle fracture. Patients with neurovascular deficit, compound fractures, pathological fractures, and nonunion/malunited fractures were excluded. Group A had 25 patients who were treated with operative line of management and Group B had 25 patients who were treated with a conservative line of management; division was done on basis of odd (Group A)–even (Group B) technique. Results: Out of 50 patients, the mean age group of patients was 35.5 ± 1 years of life with others ranging from 16 to 60 years. Out of 50 patients, 45 (90%) patients were male and 5 (10%) were female. Out of 50 patients, 42 had a history of road traffic accidents, while 8 had a history of falls. The right side clavicle was affected in 18 patients and left was affected in 32 patients. Out of 50 patients, the mean time of union in operative group was 11.36 ± 2.56 and 11.36 ± 2.75 weeks in nonoperative group. Constant shoulder score was 85.16 ± 15.30 and 84.64 ± 13.52 in the operative group and nonoperative group, respectively. Conclusion: In this prospective cohort study, we have concluded that long-term functional outcomes of conservative versus operative management of displaced mid-shaft clavicle fracture are similar, but primary open reduction with internal fixation of displaced mid-shaft clavicle fracture in young adult patients ensures anatomical reduction, early mobilization, and faster recovery for functional activity while avoiding complications such as malunion.

Keywords: Conservative, displaced, mid-shaft clavicle, operative


How to cite this article:
Jain D, Vieira A, Mahajan A, Naik A, Kotecha H, Issrani M. Does operative management provide better outcome in displaced mid-shaft clavicle fractures? A randomized control study. J Orthop Dis Traumatol 2022;5:41-5

How to cite this URL:
Jain D, Vieira A, Mahajan A, Naik A, Kotecha H, Issrani M. Does operative management provide better outcome in displaced mid-shaft clavicle fractures? A randomized control study. J Orthop Dis Traumatol [serial online] 2022 [cited 2022 May 24];5:41-5. Available from: https://www.jodt.org/text.asp?2022/5/1/41/339682




  Introduction Top


About 2.6%–12% of all fractures and 44%–66% of shoulder fractures are accounted by clavicle fracture.[1] Middle one-third of the clavicle contains the smallest amount of soft tissue and is the thinnest which comprises 69%–81% of clavicle fracture; 17% of clavicle fractures are in the lateral one-third, and 2% are in the medial one-third.[2] Allman classification is one of the classifications used for clavicle fracture and mid-shaft clavicle fractures are Allman Type 1.[3]

Clavicle fractures were managed conservatively most of the times in the past and operative management has been an increased tendency to improve functional outcome because displaced clavicle fractures create a cascade of changes that can result in decreased shoulder function and strength.[4],[5],[6],[7] The shortened malunion of the clavicle changes the length-tension relationship of the musculature of the shoulder.[6] Those muscles lose mechanical efficiency, which decreases strength.[6] Shoulder extension, internal rotation, and adduction are the most affected functions with a decrease in strength. Displacement of >2 cm or >10% is presumed to be an indicator for poorer outcomes and a possible increased risk of glenohumeral arthritis in those managed conservatively.[8] While plate fixation corrected the posterior and superior translations found in malunion at lower abduction angles, there was excessive anterior and inferior translation at overhead angles.[6]

The rate of nonunion was quite higher in conservative line of management (15.1%) as compared to operative line of management (2.2%).[8] Functional outcomes and patient satisfaction following plate fixation of displaced mid-shaft clavicular fracture were superior to those following nonoperative treatment of such fractures.[9]

However, managing fracture clavicle by operative methods is not complication free, there can be scarring or wound hypertrophy, surgical site infection, nonunion, delayed union, implant loosening and breakage, intraoperative brachial plexus injury, or great vessel damage.[10]

The aim of the present study was to find out does operative management in displaced mid-shaft clavicle fractures provide better outcomes than conservative?


  Materials and Methods Top


Trial design

This cross-sectional study was conducted at a tertiary high volume trauma care center in Navi Mumbai, Maharashtra, India, between December 2017 and July 2019.

Participants and randomization

A total of 278 patients presented with displaced mid-shaft clavicle fracture of which 58 patients met the inclusion criteria and were initially enrolled in the study. Six patients were lost to follow-up at the end of 6 months and 2 patients died because of the preexisting comorbidity 5 months postoperative.

A total of 50 patients matched the criteria and were included in the study at the end. All the patients were told in detail about the procedure and randomization was done using the odd (Group A)–even (Group B) technique. Every odd-numbered patient was planned for operative line of management and even-numbered patient was planned for conservative line of management. The Institutional Ethical Committee approval was obtained before commencement of the study.

Inclusion and exclusion criteria

Patients between the age group of 16 and 60 with isolated closed displaced acute mid-shaft clavicle fractures were included in the study. Patients with a pathological fracture, open fracture, any associated neurovascular deficit, or old fracture were excluded from the study.

Surgical technique

Surgical procedure was performed under general anesthesia on a radiolucent table with a towel beneath the scapula. Parts were painted and draped from neck to fingertips of the involved side upper limb. Three doses of second-generation cephalosporin - 1 dose preoperatively and 2 doses postoperatively at an interval 1of 12 hour was given.

About 8–9.5 cm incision was made in the anterior aspect in the center of clavicle over the fracture site. Reduction of fracture fragments was done and the plate was applied on the superior aspect of clavicle.

The locking compression plate was fixed to the medial and lateral fragment with appropriate screws, and at least three screws in medial and lateral fragment each were applied.

Postoperative protocol

Arm pouch was used to immobilize the operated limb. Physiotherapy of the operated arm was started at the end of 3 days. Only pendulum exercises at the shoulder in the arm pouch were allowed. After 1 month postoperative, active range of motion of the shoulder was allowed and abduction was restricted to 80°. After 2 months, active rom in all planes was allowed [Figure 1], [Figure 2], [Figure 3].
Figure 1: Postoperative range of motion: Abduction and adduction

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Figure 2: Preoperative and postoperative X-ray

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Figure 3: Postoperative range of motion – flexion and extension

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Follow-up and outcome analysis

Regular follow-up for all the patients was done at 3, 6, and 12 months.

The outcome was measured using the constant Murley Score.[11],[12]


  Results Top


Out of 50 patients, the mean age group of patients was 35.5 ± 1 years of life with others ranging from 16 to 60 years. Out of 50 patients, 45 (90%) patients were male and 5 (10%) were female. Out of 50 patients, 42 had a history of road traffic accidents, while 8 had a history of falls. Right side clavicle was affected in 18 patients and left was affected in 32 patients. Out of 50 patients, the mean time of union in operative group was 11.36 ± 2.56 and 11.36 ± 2.75 weeks in nonoperative group. The constant shoulder score was 85.16 ± 15.30 and 84.64 ± 13.52 in the operative group and nonoperative group, respectively. There were three patients who had developed superficial infection in the operated group which was managed with oral antibiotics. One patient in the postoperative group had stiffness of the shoulder. There was no case with deep infection/numbness at surgical site/medial sternoclavicular pain in the present study [Table 1].
Table 1: Demographic and statistical analysis

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  Discussion Top


Clavicle forms the pectoral girdle by acting as a connection between axial and appendicular skeleton in conjunction with the scapula. Attachments of the clavicle allow for significant function and ROM of the upper extremity as well as protection of posterior neurovascular structures. Each part of clavicle has a purpose in regard to its attachments that affects the overall physiology of the pectoral girdle.[13] While the sternocleidomastoid muscle contracts the medial fragment superiorly and posteriorly, pectoralis major and latissimus dorsi contracts the lateral fragment medially and leads to shortening. The lateral fragment is further rotated anteriorly and pulled inferiorly by the weight of the shoulder girdle.[14],[15],[16]

Clavicle fractures since ancient times are being treated by conservative methods such as clavicle brace and arm sling support. These nonoperative methods of treatment of all clavicle fractures produced better results in the general population but not in people like manual laborers who require overhead abduction of limb regularly.[17] To decrease the duration of treatment and to achieve early union of displaced fracture clavicle and early mobilization of shoulder and good functional outcome, ORIF with limited contact dynamic compression plate was used and found to be having good to excellent result with early return to respective job.

Neer and Rowe did the earlier workup on mid-shaft clavicle fractures and said that these fractures can be successfully treated by conservative modality. They mentioned a nonunion rate of 0.13% and 0.85%, respectively, which further inclined many orthopedic surgeons toward conservative treatment.[18],[19] However, lower rates of nonunion in the above-mentioned studies will be because of inclusion of the pediatric population. Moreover, the new meta-analysis and randomized controlled trials have shown an incidence of nonunion as high as 30% with conservative treatment. Apart from the complications such as persistent pain, decreased shoulder function, and nonunion, malunion has been easily seen in patients treated nonoperatively.[20],[21]

The gold standard in treatment of clavicle fractures will be with limited contact dynamic compression plate as there is direct visualization and gives rigid fixation apart from being less technically demanding as compared to other techniques. With the advent of locking plate, a stable internal fixation can now be achieved, especially in patients with poor bone quality and communition.[22]

In a systematic review and meta-analysis, Diederik PJ in his study showed that surgical treatment of mid-shaft clavicle fractures resulted in decreased nonunions, decreased malunions, and an accelerated return to daily activities, but functional outcomes were comparable between the two groups. Hence, it should always be kept in mind that patient-specific factors should be taken into account. The final decision for surgical or conservative treatment should be based on a shared thought process.[23]

Lazarides and Zafiropoulos in their study of 2006 did a retrospective study, review of 132 patients with 1 complete union of fractures of the middle third of the clavicle 2 after nonoperative management.[24] A final analysis was done with the help of a questionnaire in terms of residual symptoms and overall patient satisfaction after treatment. Clavicular shortening after union was calculated on an chest X-ray (AP view).[24] 84 was the mean modified constant score (range, 62–100) and 30 months was the mean follow-up duration (range, 12–43 months).[24] Unsatisfactory outcome was seen in 34 (25.8%) patients.[24] Final clavicular shortening of >18 mm in male patients and of >14 mm in female patients was significantly associated with an unsatisfactory result.[24]

Karibasappa and Srinath et al., 2014, made analysis on 50 patients of acute displaced mid-shaft clavicular fractures where treatment was either by surgical methods (plate osteosynthesis, n = 25, Group I) or conservative methods (n = 25, Group II). Follow-up assessment was done at 3, 6, 12 weeks, 6 months, and 1 year. DASH score and constant shoulder score were used to assess fracture union time, complications, and functional outcome. All the fractures in Group I united and two cases of symptomless malunion (8%) and one case of delayed union (4%) were reported. Whereas in Group II, 4 cases of nonunion (16%), 6 cases of symptomless malunion (24%), and delayed union in 2 cases (8%) were observed. Group I compared to Group II has shown less time for fracture union. Functional outcome was significantly good in surgically treated group at follow-ups. In this study, ORIF with limited contact dynamic compression plate of acute displaced mid-shaft clavicular fractures showed faster fracture union with less complications and good Functional outcome in Group I compared to those who were treated conservatively (Group II).[25]

Mishra et al. did a study in 2017 where 36 patients with closed mid-third clavicle fractures were managed, 17 with the help of clavicle brace, and 19 with open reduction and LC-DCP fixation. They tracked the cases for 18 months at 1-month intervals. The mean time of fracture healing in surgical group was 8 weeks, less than time average time (12 weeks) taken by fracture healing in nonoperative-treated patients. Seventeen patients treated nonoperatively had good-to-average functional results and 19 patients treated surgically had excellent functional outcomes at 4 weeks of the treatment.[17]

The results of our study of patients with middle third clavicle fractures were analyzed with the results of standard literature. The results were compared with studies conducted by Kulshrestha et al., Virtanen et al., and Smekal et al.[26],[27],[28] in terms of mean age group of patients included in the study, time of union, and outcome assessed with constant Murley score [Table 2].
Table 2: Comparative data analysis

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  Conclusion Top


This study is not without limitations. The small sample size and shorter duration of follow-up remain the limitations of the present study. A follow-up of all the patients in both the groups till the end of 12 months remains the strength of the present study. In this study, we have concluded that long-term functional outcomes of nonoperative versus operative management of displaced mid-shaft clavicle fracture are same, but primary open reduction with internal fixation of displaced mid-shaft clavicle fracture in young adult patients ensures anatomical reduction, early mobilization, and faster recovery for functional activity while avoiding complications such as malunion.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Egol KA, Koval KJ, Zuckerman JD. Handbook of Fractures. 4th ed. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins Health; 2010. p. 816.  Back to cited text no. 1
    
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van der Meijden OA, Gaskill TR, Millett PJ. Treatment of clavicle fractures: Current concepts review. J Shoulder Elbow Surg 2012;21:423-9.  Back to cited text no. 2
    
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Allman FL Jr. Fractures and ligamentous injuries of the clavicle and its articulation. J Bone Joint Surg Am 1967;49:774-84.  Back to cited text no. 3
    
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Lenza M, Buchbinder R, Johnston RV, Ferrari BA, Faloppa F. Surgical versus conservative interventions for treating fractures of the middle third of the clavicle. Cochrane Database Syst Rev 2019;1:CD009363.  Back to cited text no. 4
    
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Woltz S, Sengab A, Krijnen P, Schipper IB. Does clavicular shortening after nonoperative treatment of midshaft fractures affect shoulder function? A systematic review. Arch Orthop Trauma Surg 2017;137:1047-53.  Back to cited text no. 5
    
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Rosso C, Nasr M, Walley KC, Harlow ER, Haghpanah B, Vaziri A, et al. Glenohumeral joint kinematics following clavicular fracture and repairs. PLoS One 2017;12:e0164549.  Back to cited text no. 6
    
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Lenza M, Faloppa F. Conservative interventions for treating middle third clavicle fractures in adolescents and adults. Cochrane Database Syst Rev 2016;12:CD007121.  Back to cited text no. 7
    
8.
Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of midshaft clavicle fractures: systemic review of 2144 fractures: On behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma 2005;19:504-7.  Back to cited text no. 8
    
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van der Ven Denise JC, Timmers TK, Flikweert PE, Van Ijseldijk AL, van Olden GD. Plate fixation versus conservative treatment of displaced midshaft clavicle fractures: Functional outcome and patients' satisfaction during a mean follow-up of 5 years. Injury 2015;46:2223-9.  Back to cited text no. 9
    
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Clitherow HD, Bain GI. Major neurovascular complications of clavicle fracture surgery. Shoulder Elbow 2015;7:3-12.  Back to cited text no. 10
    
11.
Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;214:160-4.  Back to cited text no. 11
    
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Fabre T, Piton C, Leclouerec G, Gervais-Delion F, Durandeau A. Entrapment of the suprascapular nerve. J Bone Joint Surg Br 1999;81:414-9.  Back to cited text no. 12
    
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Patel MM. Comparative evaluation of operative versus non-operative management of midshaft displaced clavicle fractures: A case series. Int J Orthop Sci 2017;3:594-9.  Back to cited text no. 13
    
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Pandya NK, Namdari S, Hosalkar HS. Displaced clavicle fractures in adolescents: Facts, controversies, and current trends. J Am Acad Orthop Surg 2012;20:498-505.  Back to cited text no. 14
    
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McKee MD, Wild LM, Schemitsch EH. Midshaft malunions of the clavicle. Surgical technique. J Bone Joint Surg Am 2004;86-A Suppl 1:37-43.  Back to cited text no. 15
    
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Burnham JM, Kim DC, Kamineni S. Midshaft clavicle fractures: A critical review. Orthopedics 2016;39:e814-21.  Back to cited text no. 16
    
17.
Mishra A, Kumar D, Yadav A, Pandey D, Sinha A. Functional outcome of conservative versus plate osteosynthesis in displaced midshaft clavicle fracture in manual labours. Int Surg J 2017;4:966-70.  Back to cited text no. 17
    
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Neer CS. Nonunion of the clavicle. JAMA 1960;172:1006-11.  Back to cited text no. 18
    
19.
Rowe CR. An atlas of anatomy and treatment of midclavicular fractures. Clin Orthop Relat Res 1968;58:29-42.  Back to cited text no. 19
    
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Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br 1997;79:537-9.  Back to cited text no. 20
    
21.
McKee RC, Whelan DB, Schemitsch EH, McKee MD. Operative versus nonoperative care of displaced midshaft clavicular fractures: A meta-analysis of randomized clinical trials. J Bone Joint Surg Am 2012;94:675-84.  Back to cited text no. 21
    
22.
Iannotti MR, Crosby LA, Stafford P, Grayson G, Goulet R. Effects of plate location and selection on the stability of midshaft clavicle osteotomies: A biomechanical study. J Shoulder Elbow Surg 2002;11:457-62.  Back to cited text no. 22
    
23.
Smeeing DP, van der Ven DJ, Hietbrink F, Timmers TK, van Heijl M, Kruyt MC, et al. Surgical versus nonsurgical treatment for midshaft clavicle fractures in patients aged 16 years and older: A systematic review, meta-analysis, and comparison of randomized controlled trials and observational studies. Am J Sports Med 2017;45:1937-45.  Back to cited text no. 23
    
24.
Lazarides S, Zafiropoulos G. Conservative treatment of fractures at the middle third of the clavicle: The relevance of shortening and clinical outcome. J Shoulder Elbow Surg 2006;15:191-4.  Back to cited text no. 24
    
25.
Karibasappa AG, Srinath SR. Surgical versus conservative treatment in the management of displaced mid shaft clavicular fractures: A clinical study. IJSR 2014;3:343-6.  Back to cited text no. 25
    
26.
Kulshrestha V, Roy T, Audige L. Operative versus nonoperative management of displaced midshaft clavicle fractures: A prospective cohort study. J Orthop Trauma 2011;25:31-8.  Back to cited text no. 26
    
27.
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. 27
    
28.
Smekal V, Irenberger A, Struve P, Wambacher M, Krappinger D, Kralinger FS. Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures – A randomized, controlled, clinical trial. J Orthop Trauma 2009;23:106-12.  Back to cited text no. 28
    


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