ORIGINAL RESEARCH

Section: Orthopaedics
www.ijcmr.com

Prospective Comparative Analysis of Functional Outcome of

Operative – Titanium Elastic Nailing System (TENS) Versus Non
Operative Treatment of Midshaft Clavicle Fractures
Vishwanath G Shettar1, Virendra K Bhasme2, Mrityunjaya N Battur3

shoulder.
ABSTRACT Robbin C.MeKee et al (2012) studied 421 patients with
Introduction: Clavicle fractures account for 2.6% of all randomized clinical trials comparing operative versus non-
fractures. Most common type is mid shaft fracture (80%). operative care for displaced midshaft clavicular fractures.
Operative treatment is playing an increasingly important role. They concluded that operative treatment provided a
Most of the conservative treatments need regular adjustment, significantly lower rate of nonunion and symptomatic
are cumbersome and inconvenient to the patients. malunion and an earlier functional return compared with
Material and Methods: Study is conducted in the Department
non-operative treatment.3
of Orthopaedics, Karnataka Institute of Medical Sciences,
Kong L et al (2014) - A total of 507 patients from 6
Hubballi Karnataka on patients with displaced/comminuted
clavicle fractures middle third, from January 2016 to August
Randomized Controlled Trials were subjected to meta-
2017. Patients divided into Group A (operative fixation with analysis. They concluded that operative treatment has an
TENS) and Group B (managed conservatively). effect on improving function, which is demonstrated by
Results: In all patients of GROUP A union of bone was significantly higher Constant scores and lower DASH
observed. 15 patients were satisfied with their shoulder scores. The rate of nonunion and the rate of malunion were
functions. Range of movements were better in GROUP A significantly lower in operative group compared with that in
compared to GROUP B. non-operative group.4
Conclusion: TENS Nailing for clavicle middle third fractures Therefore, operative treatment is playing an increasingly
provides an acceptable alternative method for the fixation of important role in the clinical setting, mainly using
displaced midshaft clavicular fractures and delivers better compression plating or intramedullary nail fixation.
results than conservative management.
Although plating is accepted as a standard technique, it has
Keywords: Functional Outcome, TENS, Midshaft Clavicle some disadvantages like large scar, nonunion, and difficult
Fractures application and removal of the plate. The second method,
intramedullary nailing of clavicular fracture is a relatively
new technique done using elastic titanium nails. This
INTRODUCTION technique was attractive when first presented by Jubel et al.
Some articles have recommended it as a technique with little
Of all fractures clavicle fractures account for 2.6%. Among complications, rapid union rate, easy insertion and removal,
the clavicle fractures most common type is mid shaft fractures small scar and no breakage.
(80%). Functional outcome of mid shaft clavicle fracture is So we decided to evaluate functional outcome in patients
not only related to its union, but also to its length. Clavicle treated operatively using Intra-medullary fixation by
acts as a "strut" that keeps the upper limb away from the titanium elastic nail and non-operative treatment on the mid
torso for efficient shoulder and upper limb function, while shaft clavicle fractures. Our study discusses elastic stable
also transmitting forces from upper limb to the trunk. intramedullary nailing of midshaft clavicular fractures as it
Traditionally, clavicular fracture is treated non-operatively produces excellect cosmetic and functional results.
with a figure-of-eight bandage or broad arm sling. Time-
honored treatment of fracture midshaft clavicle has been
in the form of a simple sling, figure of eight clavicular Senior Resident, Department of Orthopaedics, 2Assistant Professor,
1

brace, crepe bandage as a figure of eight, etc. But most of Department of Orthopaedics, 3Junior Resident, Department of
the conservative treatments need regular adjustment, are Orthopaedics, KIMS, Hubli, India
cumbersome and inconvenient to the patients. Outcomes of Corresponding author: Dr. Vishwanath G Shettar, Senior
non-operative treatment are not always excellent. Resident, Department of Orthopaedics, KIMS, Hubli 580022, India
In Rockwood and Green's Fractures in Adults they observed
that there has been increasing evidence that the outcome of How to cite this article: Vishwanath G Shettar, Virendra K
non-operatively treated (especially displaced or shortened) Bhasme, Mrityunjaya N Battur. Prospective comparative analysis
of functional outcome of operative – titanium elastic nailing
midshaft fractures is not as optimal as was once thought.1
system (TENS) versus non operative treatment of midshaft clavicle
Mueller et al2 (2008) –In his study, up to 31% of cases who
fractures. International Journal of Contemporary Medical Research
were treated for mid shaft clavicular fractures non-surgically 2018;5(9):I1-I5.
lead to unsatisfactory results such as nonunion, brachial
plexus irritation, shortening and limited function of the DOI: http://dx.doi.org/10.21276/ijcmr.2018.5.9.15

International Journal of Contemporary Medical Research I1

ISSN (Online): 2393-915X; (Print): 2454-7379 | ICV: 77.83 | Volume 5 | Issue 9 | September 2018
 Shettar, et al. Titanium Elastic Nailing System (TENS) Versus Non Operative Treatment of Midshaft Clavicle Fractures
Section: Orthopaedics

The aim of the study was Prospective comparative analysis • Undisplaced fracture.
of functional outcome of operative TENS Vs non-operative • Compound fractures of clavicle.
treatment on mid shaft clavicle fractures in terms of union, • Pathological fractures.
complications and functional outcome. • Hemiparesis (on the affected side).
Objective of the study was to analyse the functional and • Patients not willing for surgery.
clinical outcome in patients with midshaft clavicle fractures Non Operative Treatment
treated surgically using TENS nail and those cases managed Non-operative treatment consists of the use of figure-of-
conservatively. eight splinting with a sling for comfort.9
Anatomy of clavicle Operative treatment: Intramedullary Fixation
The only bone to attach the trunk and the upper limb is More recently, titanium elastic intramedullary nails have
clavicle. been used, with good results reported in a number of studies.
Mechanisms of injury Frigg et al. reported a reduction in complications from
Most commonly, direct blow on the point of the shoulder,5,6,7,8 60% to 17% with the use of an end cap, converting to open
which can occur in a number of ways, including being reduction after two failed attempts at closed reduction, using
thrown from a vehicle or bicycle during sports events, from careful manual passage of the nail, obtaining intraoperative
the intrution of objects or vehicle structure during a motor oblique radiographs to rule out lateral perforation, and
vehicle accident, or fall from a height. limiting postoperative range of motion to 90 degrees for 6
Clinical assessment weeks.1,9
Painful deformity and localized tenderness over the site of Advantages
clavicular fractures. The weight of the upper limb causes • Cosmetic - very small incision.
often downward displacement of the lateral fragment and • Incidence of infection – less.
medial fragment is elevated due to sternocleidomastoid • Minimally invasive.
muscle pull in the posterosuperior direction.9 • Less periosteal stripping.
Shortening of the clavicle should be measured clinically with • Relative stability to allow callus formation.
a measuring tape. • Short post op stay at hospital.
Radiographic assessment Disadvantages
With the routine anteroposterior view of shoulder, an apical • Technical difficulty because of varying degree of
oblique view must be taken for better visualization of the curvature of clavicle.
fracture pattern and displacement. • Damage to underlying vital structures.
To obtain apical oblique view, a sand bag or roll is placed • Intrathoracic migration.
under the uninjured scapular region, which one brings the • Nail breakage.
injured shoulder flat over the radiographic cassette (a true • Proper operation theatre setup (fracture table, c-arm).
AP). The beam in angled 10 to 20 degrees cephalic, which Pre operative preparation
brings image of the clavicle away from thoracic cage.9 Patients underwent a pre-operative evaluation including the
MATERIAL AND METHODS following parameters
Study is conducted in the Department of Orthopaedics, • Basic blood invesstigations.
Karnataka Institute of Medical Sciences, Hubballi Karnataka • X-ray shoulder.
on patients with displaced/comminuted clavicle fractures • Chest X ray with both shoulders.
middle third, from January 2016 to August 2017 after ethical • 0-15o lordotic view.
clearance was obtained from the ETHICAL committee of • 15-30o cephalad tilted view.
KIMS Hubballi. Anaesthesia
Group A 19 patients were treated with 2 mm titanium elastic General anesthesia/regional (supraclavicular) nerve block.
nail. Patient positioning
Group B 19 Patients treated by conservative management • Patients are positioned in supine position.
by means of figure of eight bandage with cuff and collar. • A small bag is placed behind the ipsilateral scapula.
Criteria for inclusion • The head is placed on a round support and rotated to
Patients were included in the study if they had opposite side of surgery.
• Simple mid shaft clavicle fracture with >2cm • The upper limb is drapped free to aid in closed reduction
displacement. of fragments.
• Comminuted fracture mid-shaft clavicle. Operative technique
• Fractures associated with neurovascular injury. • At the sternal end of the clavicle, a skin incision of 2 cm
• Age: 20-50 yrs. is made parallel to the clavicle.
Criteria for exclusion • The anterior cortex is opened with an awl about 1.5 cm
Patients were excluded from the study if they had lateral to the sternoclavicular joint.

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International Journal of Contemporary Medical Research
Volume 5 | Issue 9 | September 2018 | ICV: 77.83 | ISSN (Online): 2393-915X; (Print): 2454-7379
Shettar, et al. Titanium Elastic Nailing System (TENS) Versus Non Operative Treatment of Midshaft Clavicle Fractures

Section: Orthopaedics
• A titanium elastic nail of appropriate size is inserted and
advanced to the fracture site.
• Subsequently, the fracture is reduced in a closed manner.
• Reduction is maintained provisionally with a small
reduction forceps
• The nail is subsequently advanced across the fracture into
the lateral fragment with gentle rotational movements. Figure-1:
• Care was taken that the implant is not advanced
too laterally in order to avoid penetration into the
acromioclavicular joint.
Post operative and follow up
• Postoperatively the limb was immobilised with sling.
Active range of motion (ROM) exercises -elbow, wrist
and hand under the supervision of a physiotherapist was
started.
• Immediately after surgery, the affected limb was
supported with a shoulder immobiliser for 3 weeks.
• The sling prevented the arm from drooping and
interfering with bone union while allowing passive
exercises.
• At 4th week the range of movements of the pendulum
swings increased gradually up to 90°
• At 6th week full range of movements were obtained. All
patients were advised to return to light work and day
Figure-2:
to day activities as long as tolerable and radiologically
acceptable.
Assessment
• Both an anteroposterior and a 10-20o cephalad tilted
radiographs were made for each patient.
• All patients were assessed with standard protocol in
which they were assessed at fourth week, sixth week,
and once in a month with clinical and radiological
parameters for proper alignment of fragments, fracture
union, non union, malunion, infection and functional
parameters.
• Using CONSTANT SCORE and DASH SCORE
objective and subjective shoulder function was
measured.
STATISTICAL ANALYSIS Figure-3:
The information collected regarding all the selected cases
were recorded in a master chart. Data analysis was done with
the help of computer by using SPSS software and Sigma
Stat 3.5 version. Using this software, percentage, mean,
standard deviation and ‘p’ value were calculated through one
way ANOVA, and p value of less than 0.05 was taken as
significant.
RESULTS
Time to bony union
In all patients of GROUP A union of bone was observed, and
mean time required to bony union was 13.16 weeks (range
from 11 to 20 weeks). 15 patients were satisfied with their
shoulder functions.
Range of Movements: Range of movements were better in
Group A compared to Group B. Figure-4:

International Journal of Contemporary Medical Research I3

ISSN (Online): 2393-915X; (Print): 2454-7379 | ICV: 77.83 | Volume 5 | Issue 9 | September 2018
 Shettar, et al. Titanium Elastic Nailing System (TENS) Versus Non Operative Treatment of Midshaft Clavicle Fractures
Section: Orthopaedics

Constant shoulder score

The Disabilities Of The Arm, Shoulder And Hand
(DASH) Score
Complications
Among 19 patients in Group A, following complications
were seen. 2 patients had infection which was controlled
with oral antibiotics, 4 patients had hardware prominence for
which 2 underwent surgery i.e. implant removal done after
the 3rd month of surgery and shoulder functions improved. In
Group B, one patient had non union.
DISCUSSION
In our study, we found that closed or limited open reduction and
internal fixation with TENS in the treatment of midclavicular
fractures in adults resulted in a high fracture healing rate,
rapid functional recovery and minimal complications. The
procedure is minimally invasive and achieved high patient
satisfaction.
Figure-5:
Some systematic reviews on clavicle fracture treatment have
Shortening Of Clavicular Length Group A Group B been reported in previous studies. For example, Zlowodzki
(in mm) et al10 showed that the non union rate can reach 4% by
Mean 4.83 9.92 operative treatment and 6% by non-operative treatment.
Standard deviation 0.77 1.02 However in our study we were having 0% non-union rate
P value Unpaired t test <0.0001 in operative treatment with 5.26% non-union rate in non-
Table-1: operative treatment. The non-union rate of non-operative
treatment is consistent with Zlowodzki et al.10
Constant shoulder score distribution Group A Group B Our study shows that mid shaft clavicular fractures more
Mean 71.16 55.63 commonly occurs in the young active adults, males were
Standard deviation 2.95 5.82 four fold affected than female. This result is consistent with
P value Unpaired t test <0.0001 many other studies (Hassan Keihan Shokouh et al11, Yun-
Table-2: feng Chen12, Bing-fang Zeng et al13). The union rate of our
study for operative treatment is 13.16 weeks. This result is
The disabilities of the arm, shoulder Group A Group B consistent with Anish et al (2012) - in his study they noted
and hand (DASH) score distribution 100% union at an average of 12.3 weeks.
Mean 91.11 73.84 The mean Constant score and DASH score were
Standard deviation 4.08 8.63 comparatively better than non operative method. This result
P value Unpaired t test <0.0001 is consistent with the following studies - Kong L et al (2014),
Table-3: Smekal V (2009).2
The results showed that there were statistical differences in
Age distribution the non-union, malunion and neurological complication rates
In group A 9 patients were <30 years (47%), next common between operative and non-operative treatment, suggesting
age group was 31 to 40 years (32%) operative treatment could decrease the incidence rate of
In group B 10 patients were <30 years (52%). these adverse events.
Gender Plating is the standard technique for operation of clavicle
In group A 13 patients were male and 6 were female. fracture when surgery is required, But fixation of clavicle
In group B 15 patients were male and 4 were female. fracture by elastic titanium nails is a new technique and can
be used on demanding patients. We had favourable results
Fracture laterality distribution
with this technique in cases with midshaft clavicular fracture.
In group A 11 patients were right sided and 8 were left sided.
Our study had some limitations namely the smaller sample
In group B 14 patients were right sided and 5 were left sided.
size and surgery performed by different surgeons.
Shortening of clavicular length
After union, shortening of clavicular length was measured CONCLUSION
radiologically as the linear difference of clavicle lengths Based on the results of the study the following conclusions
from sternal end to acromial end between operated and were made. This study shows that early primary fixation
normal side. of fractures of clavicle with TENS result in earlier return
Clavicular lengths were significantly better maintained by to function. Operative treatment reduces the nonunion,
TEN (P <0.0001) than by non operative management. malunion and neurological complication rates of clavicle

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International Journal of Contemporary Medical Research
Volume 5 | Issue 9 | September 2018 | ICV: 77.83 | ISSN (Online): 2393-915X; (Print): 2454-7379
Shettar, et al. Titanium Elastic Nailing System (TENS) Versus Non Operative Treatment of Midshaft Clavicle Fractures

Section: Orthopaedics
fractures. It increases the functional outcome of the patients.
For clinical application, we should make decisions in
accordance with specific conditions. In order to avoid the risk
of adverse events, operative treatment is a better therapeutic
method if it is matched to the individual patient.
To conclude, TENS Nailing for clavicle middle third fractures
provides an acceptable alternative method for the fixation of
displaced midshaft clavicular fractures and delivers good
results.
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Source of Support: Nil; Conflict of Interest: None

Submitted: 23-07-2018; Accepted: 25-08-2018; Published: 06-09-2018

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ISSN (Online): 2393-915X; (Print): 2454-7379 | ICV: 77.83 | Volume 5 | Issue 9 | September 2018