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ligament.1 The present consensus that great majority of clavicular fractures heal with non operative treatment is no longer valid.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

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

where

z is the z score

ε is the margin of error

N is population size

p̂ is the population proportion

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)

Figure 2

Small incision of 1-1.5cm

Figure 3

Entry point

Figure 4

Tens with T-handle

Figure 5

Reduction done percutaneously

Figure 6

Intraopertive C arm pictures

Figure 7

After wound closure

Figure 8

Mini open technique at the fracture site

Figure 9

Pre operative X-ray

Figure 10

Post op day 1

Figure 11

6 weeks follow up

Figure 12

12 weeks follow up

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Minimal and surgically satisfactory scar

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

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.

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.

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

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

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

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.

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.

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

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

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.

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

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 12^th 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.