European Journal of Cardiovascular Medicine

Clavicle fractures occur in 3-5% of all fractures.[1] Approximately 80% of clavicular fractures occur in the midshaft, with more than 50% of these fractures being displaced.There are multiple methods for stabilizing midshaft clavicular fractures (MSCFs) described in the literature.[3-6] The two most common methods for fixing midshaft clavicular fractures are intramedullary nailing and rigid fixation with plates. Open reduction and internal fixation with a plate is a commonly used technique, but it has drawbacks such as challenging application, prominent scarring, increased risk of nonunion, and issues with removal.[7] On the other hand, intramedullary nailing prevents these complications and offers benefits such as fast union, easy application and removal, and minimal scarring. In 2003, Jubel et al. [6] pioneered the introduction of the titanium elastic nail (TEN) technique for intramedullary fixation in clavicular fractures. The study aimed to evaluate the effectiveness of using a Titanium Elastic Nail (TEN) system in treating midshaft clavicle fractures.

The present study is a hospital based prospective study done n a orthopedic department of tertiary care hospital in Central India.The comprehensive data is gathered from patients using a particularly crafted Case Record Form (CRF) through obtaining the medical history, conducting a thorough clinical examination, and necessary investigations.Following the diagnosis, patients are chosen for the study based on certain inclusion and exclusion criteria. Postoperatively, all cases are monitored until fracture union occurs, often for a minimum of 6 to 12 months. The results were examined using both clinical and radiographic methods.

 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.

 50 cases fulfilling the inclusion criteria and consenting to participate in the study were selected as study participants and underwent surgery at our facility. The results are assessed using The Disabilities of the Arm, Shoulder, and Hand (DASH) Score.

Our study involves conducting the following investigations in each subject. All patients in the research undergo a comprehensive investigation including routine blood tests, HIV, HbsAg, and preoperative radiological examinations. Chest X-rays provide an anterior-posterior view, encompassing the shoulder joint. Apical and oblique views of the clavicle if needed. Prior to conducting investigations and surgical treatments, written informed consent was sought from each patient or their legal guardian. Radiological assessments were conducted after the surgery and at 6-week, 12-week, and 6-month intervals. Patients were monitored at 6 weeks, 12 weeks, and 6 months.

 Surgical Technique

The patient is positioned lying on their back on a table that allows X-rays to pass through. All the essential instruments needed for the surgical process were organized on a sterile cart. A tiny towel placed under the area between the shoulder blades to raise the shoulder. A 1-1.5cm skin incision is made parallel to the clavicle at the sternal end of the collarbone. An incision was made with a bone awl approximately 1-1.5 cm to the side of the sternoclavicular joint, opening the anterior cortex. A 2mm diameter TEN is inserted and advanced to the fracture site under c-arm guidance. The fracture is then reduced non-surgically. If closed reduction is not feasible, a 1-2cm skin incision is performed at the fracture site level for open or mini-open fracture reduction using a mini open approach. Reduction is temporarily maintained with a tiny reduction forceps or through percutaneous manipulation. The nail is then moved forward over the crack into the side fragment using delicate rotational motions. Ensure the implant is not inserted too far to the side to prevent it from penetrating the acromioclavicular joint. The innermost part of the nail is trimmed and the skin above it is stitched following the cleaning procedure.

In Table 1, the distribution of age, gender, mode of injury, and side affected among 50 patients is outlined. The majority of patients fall within the age range of 19-29, constituting 70% of the total, followed by those aged 30-39 and 40-49, comprising 20% and 10% respectively. Gender distribution shows a higher representation of males at 70%, while females account for 30% of the sample. Regarding the mode of injury, road traffic accidents are predominant, affecting 80% of patients, followed by falls from height and falls on outstretched hands, both at 10%. In terms of the side affected, the right side is more commonly involved, with 80% of cases compared to the left side's 20%. Overall, these findings provide insights into the demographics and patterns of injury among the sampled population.

In Table 2, which delineates associated injuries among the patient cohort, scapula neck fractures are observed in 3 individuals, representing 6.66% of the sample, while rib fractures are noted in 5 patients, accounting for 10%. These findings underscore the presence of concurrent injuries alongside the primary injuries outlined in Table 1, providing additional context to the overall clinical picture and potential complications in the patient population.

Table 3 presents the classification of injuries observed within the patient cohort. The majority of injuries fall under Robinson type B, comprising 90% of cases, with the remaining 10% classified as type B1. In terms of the OTA classification, the majority of cases (90%) are categorized as 15b1, while the remaining 10% are classified as 15b2. These classifications offer insight into the specific types and severity of injuries sustained, aiding in treatment planning and prognosis assessment within the studied population.

Table 4 provides details on preoperative shortening and displacement among the patient sample. The majority of patients exhibit shortening ranging from 1.5 to 1.9 cm, representing 80% of cases, while a smaller proportion, constituting 20%, demonstrate shortening between 2 cm to 2.5 cm. These findings shed light on the extent of preoperative deformity, which is crucial for surgical planning and outcome prediction in the management of the observed injuries.

Table 5 outlines the surgical techniques employed in the treatment of the patient cohort. The majority of procedures were conducted using a closed surgical approach, with 47 cases, representing 93.33% of the sample. In contrast, a smaller proportion, comprising 6.66% of cases, necessitated an open surgical technique. These data highlight the predominant utilization of closed procedures in the management of the observed injuries, with a minority requiring more invasive open interventions.

Table 6 delineates the types of implants utilized in surgical interventions within the patient cohort. Among the TENS implants, 20% of patients received 1.5mm implants, while the majority, constituting 80%, were provided with 2.0mm implants. These findings underscore the prevalence of 2.0mm implants in the surgical management of the observed injuries, potentially reflecting their suitability and effectiveness in addressing the identified conditions.

Table 7 details the extent of postoperative shortening observed among the patient cohort. The vast majority of patients, comprising 96.67% of cases, experienced no shortening following the surgical intervention. A smaller subset, accounting for 3.33% of cases, exhibited minimal shortening of less than 0.5cm. These results indicate a generally successful surgical outcome in terms of restoring anatomical alignment and minimizing postoperative deformity within the studied population.

Table 8 presents complications observed in patients who underwent surgery with TENS implants. Among the 50 cases studied, the most common complication was entry site irritation, reported in 7 patients. No instances of pin tract infection, refracture, non-union, neurovascular damage, superficial infection, iatrogenic perforation of cortex (posterior), or lateral nail migration were noted. These findings suggest a relatively low incidence of complications associated with TENS implantation in the studied population, with entry site irritation being the primary concern.

Table 9 presents the distribution of DASH (Disabilities of the Arm, Shoulder, and Hand) scores among the patient cohort. The majority of patients, comprising 80% of cases, achieved an excellent score, indicating minimal disability and optimal functional outcomes postoperatively. A smaller proportion, accounting for 20% of cases, attained a good score, reflecting satisfactory but slightly less favourable functional outcomes compared to those categorized as excellent. These findings suggest overall positive postoperative functional status among the studied population, as assessed by the DASH score.

Historically, midshaft clavicle fractures were managed without surgery.  Clavicle fractures are typically managed non-surgically. Hill et al. in 1976 and Mckee et al. in 2006[8] discovered unsatisfactory outcomes when using conservative treatment for displaced midshaft clavicle fractures. [9] Fractures that are displaced and have an initial shortening of more than 20 mm are linked to a higher risk of nonunion and a negative clinical outcome. [9]
JUBEL et al. [10] demonstrated that correcting clavicular shortening is necessary for achieving a positive functional outcome. No cases of nonunion or poor functional outcomes were observed in their study. Surgical procedures utilizing plate fixation have demonstrated significant complications like hematoma, infections, implant failures, and non-union when compared to conservative management. Bostman et al. [11] Minimally invasive ESIN was developed as a substitute for plate fixation. Intramedullary implants are advantageous due to their biomechanical compatibility, as they can adapt to changes in tension on the clavicle caused by arm rotation and loading direction. [12,13]Other advantages of intramedullary nailing are a smaller incision and minimal periosteal stripping.

Retrieve characteristics of the load sharing device.[14] The relative stability facilitates abundant callus formation during the healing process. At the conclusion of our study, all 50 patients were included in the follow-up, with 35 (70%) being male and 15 (30%) female. All patients had closed fractures. Out of the 50 patients in our study, 40 patients (80%) experienced fractures as a result of road traffic accidents, 5 patients (10%) sustained fractures from indirect injuries such as falling on an outstretched hand, and 5 patients (10%) due to falling from a height. Out of the total 50 patients in our study, 40 patients (80%) were between the ages of 19 and 29, while 10 patients (20%) were in the 30-39 age group. 5 patients, which accounts for 10%, were in the 40-49 age group. The youngest participant in our study was 19 years old, while the oldest was 48 years old. The mean age was 32 years, with a range from 19 to 49 patients 45 (90%) were classified as Robinson Type B, while  5 patients (10%) were categorized as Robinson Type B1 in our study.45 patients were classified as OTA type 15b1, representing 90% of the total, while 5 patients were categorized as OTA type 15b2, accounting for 10%. 3  patients (6.66%) had a fractured neck of the scapula, and 5 patients (10%) had a rib fracture without hemothorax or pneumothorax. In our study, 5 patients (10%) underwent surgery on the first day.40  patients, accounting for 80% of the total, underwent surgery within a timeframe of 2 to 7 days. five  patients, accounting for 10% of the total, underwent surgery between the 7th and 14th days. The surgical procedure was carried out within an average of 3-4 days, with a range from 1 to 14 days.
Out of the 50 patients in our study, 40 (80%) had shortening between 1.5 and 2cm, while 10 (20%) had shortening between 2 and 2.5cm, with an average shortening of 1.80cm.
All patients in the study had a displacement greater than 2cm, with an average displacement of 2.2 cm. After surgery, 48 patients (96.67%) did not experience shortening, while 2 patient (3.33%) had less than 0.5cm shortening. In our study, 10 patients (20%) received 1.5mm TEN nails, while 40 patients (80%) received 2mm TEN nails, with an average size of 2mm used.

Out of 50 patients in our study, closed reduction was performed on 47 patients (93.33%) while open reduction (Mini-open technique) was required for 3 patients (6.66%).
45 out of 50 patients (90%) had their fractures healed by the end of the 12th week after the operation in our study.5 out of 10% of patients had their fractures healed by the 14th week. All five patients were over 40 years old, and 3 patients had a Robinson type B1 fracture.
The study found an average DASH score of 3.0023, with 80% of patients achieving an excellent score and 20% achieving a good score. 7 patients (13.33%) experienced skin irritation caused by a prominent nail on the medial side, leading to nail removal at 14 weeks. All 7 patients achieved fracture union within the specified time. No patient in our study experienced perforation of the dorsolateral cortex.

In our research, intramedullary nailing resulted in prompt functional recovery for all participants. Minimally invasive procedures can achieve quick and painless functional recovery with lower chances of complications compared to conservative treatment. The average duration of disability is brief. TENS is a secure and minimally invasive method used to stabilize displaced midshaft clavicle fractures. It provides excellent cosmetic and functional outcomes with a rapid recovery time.

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2. Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am 2007;89(1):1–10. DOI: 10.2106/JBJS.F.00020
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