• Article highlight
  • Article tables
  • Article images

Article History

Received : 24-12-202

Accepted : 22-03-2021

Available online : 12-06-2021



Article Metrics




Downlaod Files

   


Article Access statistics

Viewed: 98

PDF Downloaded: 101


Shakeel and Sreenivasa N: Surgical management of midshaft clavicle fracture by titanium elastic nailing system


Introduction

Clavicular fracture is one of the most common bony injuries. In adult it accounts for 2.6% to 4% fractures and 35% of injuries to the shoulder girdle.

The clavicle is a S-shaped bone that acting as a strut between the sternum and the glenohumeral joint. It also has a suspensory function to the shoulder girdle. The shoulder hangs from the clavicle by the coracoclavicular ligament.1 The present consensus that great majority of clavicular fractures heal with non operative treatment is no longer valid. Pressure from a displaced fragment on the retro clavicular part of the brachial plexus may cause symptoms after conservative treatment. Recent studies have shown that higher rate of non-union and specific deficits of shoulder function in subgroups of patients with these injuries. Hence they can be treated as a spectrum of injuries requiring careful assessment and individualized treatment. Nonunion after a clavicular fracture is an uncommon occurrence, although the prevalence is higher than previously reported. Also persistent wide separation of fragments with interposition of soft tissue may lead to failure of closed reduction. There is 15% non-union rate in widely displaced fractures of middle-third of the clavicle treated without surgery. And all fractures with initial shortening of more than 2cm resulted in nonunion.2

The indications for surgery include the need for earlier functional mobilization in the patient with an isolated injury, in addition to open fractures, floating shoulders and patients with poly trauma.3 Hence, more recently, there has been a trend toward surgical fixation. A systematic review showed relative risk reduction of 72% and 57% for non-union when using intramedullary fixation and plate fixation, respectively, when compared with non-operative treatment of mid shaft clavicle fractures.4 Intramedullary devices behave as internal splints that maintain alignment without rigid fixation. One advantage of the TENS is that it can block itself in the bone and provide a three-point fixation within the S-shaped clavicle.5 However, some studies have shown a relatively high complication rate and technical difficulties with intramedullary nailing.5

The main aim of this study is to evaluate the functional outcome of mid shaft clavicle fracture fixation by titanium elastic nailing system.

Materials and Methods

Objectives of study

  1. To study the rate of union with displaced mid shaft clavicle fractures treated with Titanium Elastic Nail.

  2. To study the functional outcomes of patients treated with Titanium Elastic Nail.

  3. To the study the advantages of Titanium Elastic Nail,

Source of data

The proposed study is a hospital based prospective study centered in VIMS Ballari, during the period from April 2018 to April 2020.

Method of collection of data

The complete data is collected from the patients in a specially designed Case Record Form (CRF) by taking history of illness and by doing detailed clinical examination and relevant investigations.

Finally after the diagnosis patients are selected for the study depending on the inclusion and exclusion criteria. Post operatively all the cases are followed until fracture union occurred for the minimum period of 6 months to 12 months. Results were analyzed both clinically & radiologically.

Inclusion criteria

  1. Patients of both the sexes aged between 18 to 50 years are included in the study.

  2. Patients with closed displaced Mid shaft clavicle fractures.

  3. Patient fit for surgery.

Exclusion criteria

  1. Open fractures.

  2. Undisplaced clavicle fracture.

  3. Patients <18 years and >50 years.

Sample size

Minimum of 30 cases satisfying the inclusion and exclusion criteria and who were willing to participate in the study were taken as study subjects and were operated in the time period between April 2018 to April 2020 were included in the study.

Figure 0
https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/8f67ed55-ad3d-4d18-8fb1-e1e4b550b225-uimage.png

where

z is the z score

ε is the margin of error

N is population size

p̂ is the population proportion

Study period

Time period of 2 years, between April 2018 to April 2020.

Evaluation

The results are evaluated with The Disabilities of the Arm, Shoulder and Hand (DASH) Score.

Investigations

In our study the following investigations are conducted in each patients. All the patients included in the study are investigated thoroughly with Routine blood investigations, HIV, HbsAg, Radiological examination pre operatively are done.

X rays of the chest including shoulder joint -AP view.

Apical and oblique view of clavicle if necessary.

Before subjecting the patients for investigations and surgical procedures, written/informed consent was obtained from each patient/legal guardian. Radiological examination was done post-operatively and at the end of 6 weeks, 12 weeks and 6 months intervals. Patients was followed up at 6 weeks, 12 weeks and at 6 months.

Surgical Technique

Patient is placed in the supine position on a radiolucent table. All the necessary instruments required for the operative procedure were arranged on a sterile trolley (Figure 2). A small towel kept under the interscapular region to elevate the shoulder. A skin incision of 1-1.5cm is made parallel to the clavicle at the sternal end of the clavicle (Figure 3). With a bone awl about 1-1.5 cm lateral to the sternoclavicular joint (Figure 4, Figure 5), the anterior cortex was opened. Under c arm guidance a TEN (average diameter 2mm) is inserted and advanced to the fracture site(Figure 6, Figure 7 ). Subsequently, the fracture is reduced in a closed manner (Figure 6). If closed reduction is not possible, a 1-2cm skin incision (mini open technique) at the level of the fracture site is made for open or mini-open fracture reduction (Figure 9). Provisionally reduction is maintained with a small reduction forceps/ with manipulation percutaneously. The nail is subsequently advanced across the fracture into the lateral fragment with gentle rotational movements. Care must be taken that the implant is not advanced too laterally in order to avoid penetration into the acromio clavicular joint. The medial end of the nail is cut and the overlying skin is sutured after the wash.(Figure 8)

Figure 1

Instruments required for the intramedullary fixation of clavicle with titanium elastic nailing system (Tens)

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/65a5394c-5922-4c3d-a46c-81c9add7d97c-uimage.png

Figure 2

Small incision of 1-1.5cm

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/ee67a41d-0b21-4397-b383-14e3888320c9-uimage.png

Figure 3

Entry point

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/d97f20f4-8dcc-458d-9192-f04a013098fe-uimage.png

Figure 4

Tens with T-handle

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/a8a7de2e-c066-459a-9be8-42d57a53db65-uimage.png

Figure 5

Reduction done percutaneously

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/ec174cc1-89b7-498e-8483-d8b1416d102e-uimage.png

Figure 6

Intraopertive C arm pictures

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/98a99ed1-03d6-4a56-8ea1-5b6250c4c48b-uimage.png

Figure 7

After wound closure

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/58ef7ad8-285f-4b4d-987b-6a202c53bc3c-uimage.png

Figure 8

Mini open technique at the fracture site

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/9f597d15-9c08-480e-92cb-134a617a867b-uimage.png

Figure 9

Pre operative X-ray

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/25ddbae6-3bc3-4234-b540-b656d9f22f7c-uimage.png

Figure 10

Post op day 1

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/e4338fb5-5e37-4488-aaa8-5ada815b450e-uimage.png

Figure 11

6 weeks follow up

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/f5d8c90b-f2ef-4cb0-9789-d37bd80f6569-uimage.png

Figure 12

12 weeks follow up

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/bf7bc81d-789b-41b1-b879-66cfd9a6eedf-uimage.png

Figure 13
https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/ca5bb9d5-7d05-4bab-8a4c-8721cb676a17-uimage.png

Figure 14
https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/e0cc09fa-93ec-4814-a6c2-85a5f32166f3-uimage.png

Figure 15
https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/998f1fad-b776-405b-945b-c04cf27f15e1-uimage.png

Figure 16
https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/b5f8b808-3e48-4c3a-a0a5-51b80fd82f58-uimage.png

Figure 17
https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/4c5d3e66-d9c9-4732-820c-14b5129f2154-uimage.png

Figure 18

Minimal and surgically satisfactory scar

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/fc28848f-7634-4adb-8dd4-ebbd21813e79-uimage.png

Results

Study consisted of 30 patients with displaced midshaft clavicle fracture treated by Titanium elastic intramedullary nail (TENS) from April 2018 to April 2020.

Mean age of patients were 34 years ranging from 18 to 50 years. Mean follow up time was 10 months ranging 6-12 months. In our study, the mode of injury was by Road traffic accident (24), fall from height(3), fall on an outstretched hand(3). The fractures were graded according to Robinsons classification and OTA (Orthopaedic trauma classification) classification. 3 patients (10%) were operated on day one.24 patients (80%) were operated from 2-7 days.

3 patients (10%) were operated from 7-14 days. The operative treatment was performed an average of 3-4 days (range: from 1 to 14 days).TEN of size 1.5mm (n=6), 2.0mm (n=24), were used according to the patient’s dimensions. Mean intraoperative time was 45 minutes (20-90 minutes). No intraoperative complications were noted in any patients. 4 patients had medial entry point skin irritation (Figure 20) due to implant prominence and which subsided once the implant was removed after the union.All the patients achieved clinical and radiological union by a mean time of 11.2 weeks (8-12 weeks). No delayed union or Nonunion were reported. Open reduction (mini-open technique) was carried out in 2 patients out of 30 patients in the form of mini-open technique with a short incision of 1-2 cm over the fracture site. DASH (Disabilities of Arm, Shoulder and Hand score) had significantly improved postoperatively excellent (Figure 14, Figure 15, Figure 16, Figure 17, Figure 18, Figure 19) in 24(80%) patients and Good in 6(20%) patients compared to preoperative DASH score. All the patients were discharged within 3 days of surgery. The mean time for implant removal was 10.2 months. Anatomical reduction, functional recovery and appearance were satisfactory in all patients. Average DASH score in our study being 3.0023.

Figure 19

Medial skin irritation due to implant prominence

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/61c0aaf8-387a-4ac8-a1f9-b47abdafcc80/image/8bc91838-3a62-4a29-be93-8a1374e1b9ab-uimage.png

Table 1

Mode of injury

No of patients

Percentage

Road traffic accident

24

80%

Fall from height

3

10%

Fall on outstretched hand

3

10%

Total

30

100%

Of the 30 patients 24 patients (80%) fracture occurred due to road traffic accident, 3 (10%)patients sustained fracture due to indirect injury, fall on outstretched hand and 3 patients(10%) due to fall from height. In all the patients fractures were closed type.

Table 2

Age incidence

Age in years

No. of patients

Percentage(%)

19-29

21

70

30-39

06

20

40-49

03

10

In our study, 70% were between the age group of 19-29 y, and 20% were between 29-39 y and 10% between 40-49y.

Table 3

Gender incidence

Gender incidence

No.of patients

Percentage(%)

Male

21

70

Female

9

30

In our study,21(70%) were males and 9(30%) were female patients.

Table 4

Side affected

Side affected

No. of patients

Percentage(%)

Right

24

80

Left

06

20

In our study, 24 patients had right sided fracture whereas 06 had it on the left side.

Table 5

Associated injuries

Type

No of patients

Percentage

Scapula neck #

2

6.66%

Rib#

3

10%

Patients (6 66% had scapula neck #,3(10% patients had rib# without haemo or pneumothorax.

Table 6

Classification

Classification

No of patients

Percentage

Robinson type B

27

90%

TypeB1

03

10%

OTA classification

15b1

27

90%

15b2

03

10%

In our study, 27 patients (90%) in our study were Robinson Type B and 3 patients (10%) were Robinson type B1.27 patients (90%) classified as OTA type 15b1 and 3 patients (10%) had OTA type 15b2.

Table 7

Preoperative shortening and displacement

Shortening

No of patients

Percentage

1.5 to 1.9cm

24

80%

2cm to 2.5

6

20%

Length of clavicle on the affected side measured from suprasternal notch to Acromioclavicular joint and compared with normal side for any shortening.

24 patients (80%) had 1.5 to 2cm shortening and 6 patients (20%) had shortening 2 to 2.5cm with average shortening of 1.92cm.

Displacement was measured radiologically. All patients included in the study had displacement >2cm, average displacement 2.2 cm.

Table 8

Surgical technique

Nature of surgery

No.of patients

Percentage(%)

Closed

28

93.33

Open

02

6.66

In our study, closed reduction was achieved in 93.3% (28 patients) and mini open technique was performed in 6.66% (2 patients).

Table 9

Type of implant used

TENS

No. of patients

Percentage

1.5mm

06

20

2.0mm

24

80

In our study, average size of tens used was 2.0mm in 80% of the patients.

Table 10

Post operative shortening

Shortening in cm

No of patients

Percentage

No shortening

29

96.67%

<0.5cm

1

3.33%

Pre operatively all 30 patients had shortening with average shortening of 1.92cm. post operatively 29 patients (90%) had no shortening, and 1 patients (20%) had <0.5cm shortening.

Table 11

Showing complications in patients with TENS

S.No

Complications

No. of Cases (n=30)

1

Entry site irritation

4

2

Pin tract infection

none

3

Refracture

none

4

Non union

none

5

Neurovascular damage

none

6

Superficial Infection

none

7

Iatrogenic perforation of cortex (posterior)

none

8

Lateral nail migration

none

In our study, 4 patients out of 30 had medial skin irritation due to implant prominence and 1 patient had superficial skin infection after 5th postoperative day which settled with oral antibiotics.

Table 12

Dash score

Score

No.of patients

Percentage(%)

Excellent

24

80

Good

06

20

In our study, Mean DASH score was 3.0023

Discussion

Traditionally midshaft clavicle fractures had been treated non-operatively.

Usually clavicle fractures are treated conservatively. Hill et al. 19976 and Mckee et al. in 2006 found poor results following conservative management of displaced midshaft clavicle fractures.7 Displaced fractures, fractures with initial shortening of >20 mm was associated with a greater risk of nonunion and a poor clinical outcome.7

JUBEL et al.8 showed that the correction of clavicular shortening is a prerequisite for good functional outcome. They observed no non union and no poor functional outcome in their study. Surgical procedures using plate fixation have shown major complications such as hematoma, infections, implant failures and non-union, in comparison to conservative management Bostman et al.9 Minimally invasive ESIN was thus established as an alternative to plate fixation.

Intramedullary implants are ideal from the biomechanical point of view as the tension side of clavicle changes with respect to rotation of arm and direction of loading.10, 11

The other potential benefits of intramedullary nailing include smaller incision, minimal periosteal stripping, and load sharing device properties.12 Its relative stability allows copious callus formation during the healing process.

At the end of our study, we had all the 30 patients in the follow up with majority being the males 21(70%) and 9(30%) female patients.

In all the patients fractures were closed type.

In our study of the 30 patients,24 patients (80%) fracture occurred due to road traffic accident,3 (10%) patients sustained fracture due to indirect injury, fall on outstretched hand and 3 patients(10%) due to fall from height.

In our study 21 patients (80%) were in the age group of 19-29 years, 6 patients (20%) in 30-39 age group. And 3 patients (10%) in 40-49 age group. Youngest patient in our study was 19 years old and oldest patient in our study was 48 years. The average age was 32 yrs (range from 19 to 49).

27 patients (90%) in our study were Robinson Type B and 3 patients (10%) were Robinson type B1.27 patients (90%) classified as OTA type 15b1 and 3 patients(10%) had OTA type 15b2.

In our study 2 patients(6.66%) had neck of scapula #,3(10%) patients had rib# without haemo or pneumothorax.

In our study 3 patients (10%) were operated in day one.24 patients (80%) were operated from 2-7 days.3 patients (10%) were operated from 7-14 days. The operative treatment was performed an average of 3-4 days (range: from 1 to 14 days).

In our study 24 patients (80%) had 1.5 to 2cm shortening and 6 patients (20%) had shortening 2 to 2.5cm with average shortening of 1.80cm.

All patients included in the study had displacement >2cm ,average displacement being 2.2 cm.

Post operatively 29 patients (96.67%) had no shortening, and 1 patient (3.33%) had <0.5cm shortening.

In our study 6 patients(20%) patients 1.5mm and in 24 patients(80%) 2mm TEN nails were used with average being 2mm used.

In our study 28 patients (93.33%) the fracture were fixed by closed reduction and 2 patients (6.66%) open reduction (Mini-open technique) was necessary.

In our study 27 patients (90%) fracture united by the end of 12th week post operatively.3 patients (10%) patients fracture united by 14th weeks. All 3 patients were above 40 years and 2 patients had Robinson type B1 fracture.

In our study the average DASH score was 3.0023 with 24 patients (80%) had excellent score, 6 patients (20%) had good score.

Skin irritation due to prominent nail on the medial side occurred in 4 patients (13.33%), which required nail removal at 14 weeks. Fracture union was achieved by the time in all 4 patients.

In our study no patient had perforation of the dorsolateral cortex.

Conclusion

In our study, intramedullary nailing provided early functional recovery in all patients. Minimally invasive techniques can fulfil the objectives of rapid and pain free functional recovery with reduced risk of complications in contrast to conservative treatment. As a result, the mean period of disability is short. TENS is a safe, minimally invasive technique for stabilization of displaced midshaft clavicle fractures with excellent cosmetic and functional results with quick recovery period.

Source of Funding

None.

Conflict of Interest

The authors declare that there is no conflict of interest.

References

1 

AR Bucholez JD Bucholez C Court-Brown Rockwood Green’s Fractures in Adults16th Edition200612136

2 

ST Canale Percutaneous epiphysiodesisOper Tech Orthop19933161510.1016/s1048-6666(06)80036-4

3 

PJ Denard KJ Koval RV Cantu JN Weinstein Management of midshaft clavicle fractures in adultsAm J Orthop20053452736

4 

M Zlowodzki BA Zelle PA Cole K Jeray MD Mckee Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: Systematic review of 2144 fractures: On behalf of the Evidence-Based Orthopaedic Trauma Working GroupJ Orthop Trauma2005195047

5 

A Frigg P Rillmann T Perren M Gerber C Ryf Intramedullary Nailing of Clavicular Midshaft Fractures with the Titanium Elastic NailAm J Sports Med2009372352910.1177/0363546508328103

6 

JM Hill MH McGuire LA Crosby Closed treatment of displaced middle-third fractures of the clavicle gives poor resultsJ Bone Joint Surg199779-B4537810.1302/0301-620x.79b4.0790537

7 

MD Mckee EM Pedersen C Jones DJ Stephen HJ Kreder EH Schemitsch Deficits following non operative treatment of displaced mid shaft clavicular fracturesJ Bone Joint Surg Am2006883540

8 

A Jubel J Andermahr C Faymonville M Binnebösel A Prokop KE Rehm Wiederherstellung der Symmetrie des Schultergürtels bei KlavikulafrakturenDer Chirurg200273109788110.1007/s00104-002-0544-z

9 

O B'ostman M Manninen H Pihlajamäki Complications of plate fixation in fresh displaced midclavicular fracturesJ Trauma19974357788310.1097/00005373-199711000-00008

10 

V Smekal A Irenberger P Struve M Wambacher D Krappinger FS Kralinger Elastic Stable Intramedullary Nailing Versus Nonoperative Treatment of Displaced Midshaft Clavicular Fractures-A Randomized, Controlled, Clinical TrialJ Orthop Trauma20092321061210.1097/bot.0b013e318190cf88

11 

M Mueller C Rangger N Striepens C Burger Minimally Invasive Intramedullary Nailing of Midshaft Clavicular Fractures Using Titanium Elastic NailsJ Trauma200864615283410.1097/ta.0b013e3180d0a8bf

12 

PJ Millett JM Hurst MP Horan RJ Hawkins Complications of clavicle fractures treated with intramedullary fixationJ Shoulder Elbow Surg2011201869110.1016/j.jse.2010.07.009



jats-html.xsl

© This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




Wiki in hindi