Clavicle fractures, accounting for 2.6% to 4% of all adult fractures, represent 35% of shoulder girdle injuries [1]. The clavicle functions as a strut connecting the sternum to glenohumeral joint while suspending the shoulder girdle through the coracoclavicular ligament[2]. The midshaft of the clavicle, due to its biomechanical vulnerability, is the most frequent site for fractures. Understanding the forces exerted on this region is critical to managing displacement and ensuring appropriate alignment, as certain fracture patterns can lead to complications if left untreated [3]. Historically, midshaft clavicle fractures were managed conservatively, with early studies reporting non-union rates below 1% [4]. However, recent evidence indicates that conservative treatment in displaced fractures is associated with higher non-union rates, reduced shoulder strength, and impaired functional outcomes [5,6]. Zlowodzki et al. conducted a meta-analysis spanning three decades and reported a significantly higher non-union rate of 15.1% for non-operatively treated displaced midshaft fractures [7]. Similarly, Hill et al. documented a 15% non-union rate with conservative management, along with fracture shortening exceeding 2 cm and patient dissatisfaction in 31% of cases [8]. Surgical management,

particularly open reduction and internal fixation (ORIF), has emerged as a preferred approach due to its ability to achieve better alignment, higher union rates, and improved functional outcomes [9-14]. Among various techniques, plate osteosynthesis and intramedullary nailing have shown particular efficacy. Intramedullary nailing using Titanium Elastic Nails (TEN) is favored for its minimal invasiveness, cost-effectiveness, and technical simplicity [15,16]. However, TEN is not without complications; issues such as nail migration, potential vessel injury due to migration, and soft tissue irritation have been reported (there is high chance of backing out of the implant after fracture union and so it may cause bursitis over the impinged area) emphasizing the need for careful technique selection [17,18]. Given the ongoing debate regarding optimal management strategies, this study was conducted to evaluate the efficacy of a novel surgical method, the Threaded Titanium Elastic Screw Nail (TTESN), in comparison to conservative management (as per recent literature). The primary aim was to assess union rates and radiological outcomes, including time to union, defined as callus formation in three out of four cortices. Functional outcomes were evaluated using the DASH (Disabilities of Arm, Shoulder, and Hand) and Constant-Murley scores at 4, 8, 12, and 24 weeks post-treatment. Complications, including non-union and procedural challenges, were also analyzed to determine the most effective approach for managing displaced midshaft clavicle fractures.

Figure 1: Intramedullary elastic titanium threaded screw nail

This prospective analytical study was conducted to compare union rates and functional outcomes in patients with displaced midshaft clavicle fractures treated using Threaded Titanium Elastic Screw Nail (TTESN) versus conservative management (as per recent literature). The study was conducted at the Department of Orthopaedics, Pt. J.N.M Medical College & Dr. B.R.A.M. Hospital, Raipur, Chhattisgarh, from December 2022 to June 2024. A total of 41 patients with completely displaced closed middle-third clavicle fractures meeting the following inclusion and exclusion criteria were enrolled.

INCLUSION CRITERIA:

1. Male and female patients aged above the age of 15 years
2. Completely displaced closed middle third clavicle fracture
3. Fracture with imminent skin perforation
4. Floating shoulder injuries
5. Patients who are medically fit for surgery.

EXCLUSION CRITERIA:

1. Pathological fractures
2. Lateral and medial end clavicle fracture
3. Uncooperative patient for post-operative rehabilitation
4. Concomitant Brachial plexus injury
5. Not willing to give consent.

Baseline demographic data, including age, sex, and injury history, were recorded. Fractures were classified using Allman’s classification, and preoperative Constant-Murley Score (CMS) and Disabilities of the Arm, Shoulder,

and Hand (DASH) scores were documented. Candidates underwent mini-open reduction and intramedullary fixation with TTESN under proper anesthesia.

SURGICAL TECHNIQUE

Painting and draping done and affected shoulder was elevated by a bump or pillow or sand bag, so that clavicle become prominent. Under C arm guidance fracture site identified first and fracture

site opened with 2-3 cm mini incision over fracture site. In all cases fracture was exposed and reduction was achieved after removal of the hematoma and cleaning the fracture ends. Then on both sides sequential reaming with k wires of increasing diameters up to 2mm to 2.5 mm was done. A 1cm skin incision made over medial end of clavicle and a hole drilled in the anterior cortex with 3.2 mm drill bit.The entry portal then enlarged with a curved awl.Then elastic threaded nail of appropriate diameter (we were provided with only 2.5 mm nails) and length inserted in the medullary canal of clavicle with a T-handle. With oscillatory to &fro rotational movements, the nail advanced until it reached the fracture site. The nail could be seen coming out of the medullary canal from the lateral end of the medial segment. The nail advanced till the nail tip is just visible from the fracture site. Then again with the help of reduction clamps the reduction was done and the nail advanced into the lateral segment of the clavicle holding the reduction.Finally when the threaded portion reached the clavicular cortex on the medial end, the nail was screwed into the bone with a screwdriver engaged to the screw head of the nail.In some cases the entry point was made from

the medial end before opening the fracture site and once part of the nail was inside the medial segment, then fracture site was opened for reduction. Initially we also fixed the screw head in the posterolateral aspect of clavicle in few cases  after inserting the nail from the lateral side .The other steps remaining the same. For lateral side insertion, the reaming k wire was advanced retrogradely from the fracture site to penetrate the posterolateral cortex for making entry point for screw nail insertion. However it was cumbersome to position the patient for lateral insertion of the nail and to find the entry point on the posterolateral aspect of the clavicle and hence after a few cases we shifted to medial end entry exclusively. The nails were inserted into the clavicle so as to reach the far most end of the clavicle .But in most cases the nail could not be advanced to more than 2-3 cm from the acromioclavicular joint. Also with the reaming K wires the appropriate length of the nail could be assessed by measuring and adding the amount of reamer going into both segments of clavicle-medial and lateral segments and appropriate length nail taken accordingly. Sometimes a butterfly fragment was present which had to be tied with polyglycolic acid/polyester to the main bone after passing the nail.

Fig 2 (a) Painting & Draping (b) Incison over fracture site along with medial entry point of nail (c) (i) & (ii) Reaming with drill bits on both fragments (d) Insertion of awl and fracture site opened, (e) Mini open reduction

Fig 2 (f) Final screwing of nail, (g) Insertion of nail through entry point near medial end of clavicle, (h) Butterfly segment tied with polyester suture, (i) Insertion of nail with oscillatory rotatory to and fro advancing movements, (j) Open Reduction of fracture with minimal incision, (k) Reduction is checked under C -ARM with nail inserted, (l) Closure in layers

Postoperative follow-up included evaluations at 4, 8, 12, and 24 weeks. Radiological union was defined as callus formation in 3 out of 4 cortices on X-rays. Delayed union was noted for healing times exceeding 3 months. Functional outcomes were assessed using CMS and DASH scores, which quantify pain, range of motion, strength, and disability.

Statistical analysis was performed using IBM SPSS 24.0. Categorical data were presented as frequencies and percentages, and continuous data as mean ± standard deviation. Chi-square tests were used for categorical variables, while unpaired t-tests compared continuous variables. A p-value <0.05 was considered statistically significant.

This study highlights the comparative effectiveness of TTESN and conservative management, focusing on union rates, functional outcomes, and complications, providing insights into optimal treatment for midshaft clavicle fractures.

Age Distribution

The study included patients across various age groups, with the majority (35%) belonging to the 21-30 and 31-40 years age brackets. The mean age was 36.05 years, indicating a predominance of young to middle-aged adults in the study population.  (Fig 3)

Figure 3: Age distribution

1. Sex Distribution

Out of 40 patients 85% were male, highlighting a significant male predominance in midshaft clavicle fractures (fig 4)

Figure 4: Sex distribution

2. Side Distribution.

The right clavicle was more commonly involved, accounting for 52.5% of cases, while the left clavicle was affected in 47.5% (fig 5)

Figure 5: Distribution according to side

Mode of Trauma

Road traffic accidents were the most common cause of midshaft clavicle fractures (82.5%), followed by self-fall (15%), and fall of an object (2.5%).   (Fig 6)

Figure 6: Distribution according to mode of trauma

Mean Time to Hospital Presentation (Table 1)

Patients presented to the hospital within a mean time of 2.80 ±1.23 days post-injury, indicating prompt healthcare access.

Table 1: Distribution according to mean time taken to present in hospital following trauma.

Constant Murley Score (CMS) (Table 2)

CMS showed significant improvement post-operatively. The mean pre-operative score of 21.07 ±3.26 increased to 37.42 ±5.93 at 4 weeks, 73.37 ±9.72 at 8 weeks, 83.05 ±10.70 at 12 weeks, and 90.70 ±11.48 at 24 weeks (p < 0.0001).

Table 2: Distribution according to Constant Murley Score (CMS):

DASH Score (Table 3)

The DASH score significantly decreased, indicating improved functional outcomes. The pre-operative mean score of 87.99 ±1.76 reduced to 50.34 ±7.86 at 4 weeks, 28.90 ±9.62 at 8 weeks, 7.19 ±11.87 at 12 weeks, and 5.86 ±11.27 at 24 weeks (p < 0.0001)

Table 3: Distribution according to DASH score

Mean Radiological Union Time (Table 4)

The mean radiological union time was 10.87 ±1.05 weeks, reflecting satisfactory healing outcomes in the study population.

Table 4: Distribution according to mean radiological union time

Complications (Table 5)

Complications included broken nails in 10% of patients, delayed union in 7.5%, and brachial plexus injury in 2.5%. No secondary procedures were required, and one patient (2.43%) with an infection was lost to follow-up (therefore had to remove from the follow up list)

Table 5: Distribution according to complications

Fig. 7: (a) Preoperative assessment with restricted overhead abduction (b) pre operative xray (c) post operative xray (4^th week) (d) 12 week post op xray (e) post operative assessment with abduction (increased range of movement of shoulder joint.) (4^th week) (f)(i) & (ii) post operative assessment 8^th week with overhead abduction and internal rotation. (8^th week) (g) (i), (ii) & (iii) post operative assessment with full overhead abduction, internal rotation and abduction. (24^th week). Complications: (h) Broken nail at the junction of thread of the screw nail and cylindrical portion (i) The nail protruding out from the insertion site after sutures were removed for persistent serous discharge

This prospective analytical study assessed union rates and functional outcomes in patients treated with Threaded Titanium Elastic Screw Nails (TTESN) for acute displaced midshaft clavicle fractures. Findings demonstrated the effectiveness of TTESN compared to conservative management, consistent with existing literature.

Union Rates and Functional Outcomes

The mean union time was 10.87 weeks, with 93% of fractures uniting within 12 weeks and all fractures achieving union by 24 weeks. These results align with studies such as those by Wasudeo et al., which demonstrated union rates within a comparable timeframe for screw intramedullary nails [19]. Functional outcomes, measured by Constant Murley Score (CMS) and Disabilities of the Arm, Shoulder, and Hand (DASH) score, showed significant postoperative improvements. CMS increased from 21.07 ±3.26 preoperatively to 90.70 ±11.48 at 24 weeks, with 85% achieving excellent outcomes. DASH scores reduced significantly from 87.99 ±1.76 preoperatively to 5.86 ±11.27 at 24 weeks, reflecting improved function and reduced disability. These findings align with Naveen et al., who reported better outcomes with operative management compared to conservative approaches [20].

Demographics and Injury Characteristics

The majority of patients (35%) were aged 21–40 years, with a mean age of 36.05 years, consistent with reports that clavicle fractures predominantly affect the active population [21]. Male predominance (85%) was noted, aligning with studies by Dhakad et al. and Gupta et al., who found males more frequently affected due to higher exposure to physical activities and trauma [22, 23]. The right clavicle was involved in 52.5% of cases, consistent with dominant-side fracture patterns observed in the literature [24].

Road traffic accidents accounted for 82.5% of injuries, followed by self-fall (15%). These findings are consistent with studies by Phanswal et al. and Kale et al., where similar trauma mechanisms were reported [25, 26].

Comparison with Conservative Management (as per recent literature)

Non-operative management has been a traditional approach to clavicle fractures, with early studies by Neer et al. reporting non-union rates as low as 1% [27]. However, more recent evidence suggests higher non-union rates (up to 15%) and poorer functional outcomes with conservative treatment, especially in displaced fractures [28]. The Juneja et al. study highlighted a 16.7% non-union rate and 16.7% malunion rate in conservatively managed cases, compared to 0% non-union in the surgical group, findings consistent with our study [29]. Similarly, Kale et al. reported malunion rates as high as 41% with conservative management, supporting the shift toward surgical intervention [26].

Comparison with Plate Osteosynthesis

Plate osteosynthesis is a widely accepted surgical option with high union rates and early functional recovery [30]. However, complications such as infection, soft tissue irritation, and hardware

prominence are significant drawbacks [31]. In our study, TTESN offered comparable functional outcomes with fewer complications. Nail breakage occurred in 10% of cases, primarily due to stress at the threaded junction.

The study by Wasudeo et al. also demonstrated the efficacy of screw intramedullary nails, reporting union in 31 of 36 patients within 12 weeks [19]. Functional outcomes, measured by CMS at six months (94 ±2.99), closely match our results at 24 weeks (90.70 ±11.48), reinforcing TTESN's utility as a minimally invasive alternative to plates.

COMPLICATIONS

The most common complication was nail breakage (10%), primarily at the threaded junction during final tightening. This aligns with previous findings, suggesting that improved implant quality and surgical technique could mitigate this issue [32]. Delayed union occurred in 7.5% of cases, resolving without further intervention. No significant soft tissue complications, or hardware prominence were observed, underscoring the safety profile of TTESN [33]. One patient out of total 41 patients (2.43%) developed infection in postoperative period and on post op dressing serous discharge came out from lateral entry point and incision site along with the nail protruded out from incision site, eventually nail was removed and kept on conservative management and follow up but the patient was lost to follow up. So had to exclude from the study.

Limitations

1. Small Sample Size: A larger cohort would enhance statistical power and generalizability.
2. Short Follow-Up Period: Six months is insufficient to evaluate long-term outcomes or complications such as implant removal.
3. Absence of Conservative Cohort: Direct comparisons with conservative management were based on literature rather than within the study cohort.
4. Implant Removal: The study did not evaluate long-term implications of implant removal, which may influence outcomes.

Threaded Titanium Elastic Screw Nails (TTESN) are a safe and effective treatment for displaced midshaft clavicle fractures, offering superior union rates and functional outcomes compared to conservative  Management. The minimally invasive nature of TTESN reduces complications while providing functional outcomes comparable to plate fixation. Future studies with larger sample sizes and longer follow-up periods are needed to further validate these findings.

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