The clavicle is a prominent, superficial, horizontal long bone that links the upper limb to the axial skeleton. Clavicle fractures are among the most common injuries encountered in orthopedic practice, accounting for approximately 5 to 10% of all fractures in adults and up to 40% of injuries in the shoulder girdle region [1-4]. Approximately 70 to 80% of these fractures occur in the middle third of the bone, where the combination of typical compressive stresses delivered to the shoulder and the thin cross-section of the bone leads to bony failure. Fractures of the shaft are most frequently observed in individuals in their early adulthood [5]. Historically, midshaft clavicle fractures that result in displacement have typically been managed with conservative treatment involving closed manipulation and immobilization using several techniques. This approach aims to achieve a high likelihood of fracture healing, favorable functional results, and a high level of patient contentment [6,7]. Nevertheless, the results of nonoperative treatment are not as advantageous as previously believed. Several investigations have shown that nonoperative therapy leads to significant rates of non-union, symptomatic malunion, and shoulder stiffness [8,9]. Hill et al [8] assessed 242 clavicle fractures that were managed non-surgically and observed unfavorable outcomes when there was an initial shortening of 20 mm or greater. The medical professionals suggested performing open reduction and internal fixation as the treatment for a badly displaced fracture located in the middle part of the clavicle in adult patients. The Canadian Orthopaedic Trauma Society recently released the findings of a multicentre randomized clinical trial. The trial compared nonoperative treatment with plate fixation for displaced midshaft clavicular fractures. The results showed that plate fixation led to better functional outcomes and a lower incidence of malunion and non-union [10]. Another study by Woltz et al also demonstrated a significantly lower non-union rate when using plate fixation for displaced midshaft clavicular fractures compared to nonoperative treatment with a sling [11]. The objective of this study is to assess the functional outcome and consequences of surgical therapy for displaced midshaft clavicle fractures using plate fixation.

This retrospective study was carried out on 30 patients who had undergone surgery open reduction and internal fixation with a plate for displaced mid-shaft clavicle fracture at the Department of Orthopaedics, Darbhanga Medical College and Hospital, Darbhanga, Bihar (India).

The inclusion criteria for this study were patients who had acute, displaced mid-shaft clavicle fractures with significant shortening (more than 2cm) displacement (more than 100% width of the clavicle), a Z-type fracture pattern, or significant comminution. Additionally, patients were included if they had impending skin compromise, were between the ages of 18 and 70 years, and had a minimum follow-up period of 12 months after the initial surgery.

The exclusion criteria included the following: an open fracture, a fracture that is not in the middle of the bone, a fracture caused by a disease, a surgical therapy other than plate fixation, delayed healing and failure of the bone to heal, and any accompanying injury to blood vessels or nerves.

A total of thirty patients who met the inclusion criteria and underwent open reduction and plate fixation were chosen as the study population. An assessment was conducted on the medical records, treatment charts, and radiographs of the chosen patients. The purpose was to determine the patient's demographic details, the cause of their injuries, the type of fracture they had, the choice of implant used, any complications during surgery, and any subsequent procedures. The chosen patients were contacted via telephone and asked to come to the outpatient department (OPD) for assessment of pain (measured using the VAS score), satisfaction with appearance (measured using the VAS score), overall treatment satisfaction (measured using a 3-point Likert scale), functional outcome (measured using the DASH Score), and satisfaction with the cosmetic appearance of the shoulder (measured using the VAS score). All thirty patients visited the outpatient department (OPD) for the final assessment of these patient-centered functional outcome measures.

The surgical procedure aimed to attain secure fixation of both pieces, restore the clavicle's length and curve, and enable prompt mobility of the shoulder. Patients received surgical intervention within a fortnight of the injury following pre-anesthetic assessment. Preventive antibiotics were administered before making the procedure. The patient was placed in a semi-sitting position known as the beach chair position while under general anesthesia. A curved cut was made along the clavicle to reveal the broken bone. The fracture was surgically realigned and stabilized using a plate positioned on the upper surface. The objective was to secure a minimum of three screws in both the primary proximal and distal pieces. Oblique fractures were repaired using a lag screw and neutralization plate. Axial compression was utilized in transverse fractures, whilst the bridge plate approach was employed in comminuted fractures. The deltopectoral fascia was sutured as a separate layer, and then the skin was closed. A collar-cuff sling was prescribed for two weeks. The sutures were extracted on the 14th day after the surgery.

Outcome measures:

The primary outcome measure was union. The secondary outcome variables included functional outcome as assessed by the DASH questionnaire, patient satisfaction with treatment and cosmetic appearance, as well as the occurrence of complications and reoperations. Fracture union was determined by observing the presence of fully formed cortical bridges between the proximal and distal fragments during radiological assessment. Fracture non-union is defined as the lack of complete bone connection between the fragments on an X-ray following at least 6 months of surgical treatment. The functional evaluation of patients was assessed using the Disability of Arm Shoulder and Hand (DASH) score, which consisted of thirty points. The DASH is a comprehensive 30-item self-report questionnaire specifically developed to assess and characterize the extent of disability in individuals with upper limb illnesses. Ensuring that the patients responded to a minimum of 27 items from the DASH questionnaire was a priority. The patient rated their pain on a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (severe pain). The satisfaction with the aesthetic appearance of the incision and shoulder was evaluated using a 10-point Visual Analogue Scale (VAS), where a higher score indicated a greater level of pleasure. The level of satisfaction with the treatment was assessed using a 3-point Likert Scale, which included options for being unsatisfied, moderately satisfied, or entirely satisfied.

Statistical Analysis: The collected data was organized into a table using Microsoft Excel 2019. Subsequently, the data was transferred to GraphPad version 8.4.3 for further statistical analysis. Student’s t-test for two samples assuming unequal variance was used to compare functional outcomes of patients with and without complication. A p-value of less than 0.05 was taken as a measure of significance.

A cohort of thirty patients with midshaft clavicle fractures underwent open reduction and internal fixation with plate fixation. Among these patients, 75% (n=25) were male and 25% (n=5) were female, resulting in a male-to-female ratio of 5:1. The mean age of the patients was 35.65 years, with a range from 18 to 70 years and a standard deviation of 11.76. High-energy trauma was the most prevalent cause of injury, accounting for 73.33% of cases, while domestic falls onto the shoulder were the most common cause within the low-energy trauma group. According to the Robinson classification, 40% of the fractures were classified as type 2B1, and 60% were type 2B2. The most frequently used plate was the 3.5 mm pre-contoured locking plate, employed in 46.67% of cases, followed by the 3.5 mm reconstruction plate in 40% of cases, and the 3.5 mm dynamic compression plate in 13.33% of cases. Table 1 provides detailed demographic characteristics of the cohort, and Table 2 outlines the types of plates used.

Table 1: Showing the comparison of baseline demographic and clinical characteristics of the study population

Table 2: Showing the comparison of different types of plates used for the internal fixation

All patients treated with open reduction and plate fixation achieved fracture union (100%) at an average time of 8.1 weeks (range 6-20 weeks; SD 2.78). Mechanical failure of the implant occurred in two patients (6.66%), manifesting as plate breakage approximately two months post-operation. Of the two broken plates, one was a 3.5 mm reconstruction plate, and the other was a locking plate. Both patients underwent implant removal, re-fixation with a new plate, and iliac crest bone grafting, achieving fracture union between 18-20 weeks. Twenty percent of patients experienced hardware-related symptoms, such as plate irritation and prominence, necessitating implant removal between 12 to 18 months after the initial surgery. Among the symptomatic hardware cases, 3 were dynamic compression plates (DCP), 2 were locking plates (LCP), and 1 was a reconstruction plate. One patient (3.33%) developed a superficial infection during the perioperative period, which was successfully treated with organism-specific antibiotics and daily dressings. The reoperation rate was 26.67%, including the 2 patients with plate breakage and 6 patients with symptomatic hardware. In all thirty patients, the surgeries were uneventful, with no intraoperative complications reported. Table 3 details the postoperative outcomes and complications.

Table 3: Showing the outcome and complications

Using a 3-point Likert scale, 84% of patients reported being fully satisfied with their treatment. Satisfaction with cosmetic appearance, measured on a 10-point Visual Analog Scale (VAS), had a mean score of 8.13±1.64. The functional outcome was favorable, with a mean Disability of Arm, Shoulder, and Hand (DASH) score of 14.15±6.54. At the final follow-up, patients reported minimal pain, with an average pain score of 0.8±1.4 on the VAS scale.

Clavicle fractures are a common injury, with those occurring in the middle third of the shaft being the most prevalent. While non-surgical treatment has been traditionally reliable, recent data indicate that fractures with significant displacement and comminution are at a higher risk of non-union when treated conservatively [11]. Additionally, a shortening of ≥20mm is a significant risk factor for patient dissatisfaction and poor functional outcomes [8,9]. This retrospective study examines fracture union, patient-reported functional outcomes, patient satisfaction with treatment and cosmetic appearance, complications, and reoperation rates following open reduction and internal fixation (ORIF) using plate fixation for Robinson type 2B1 and 2B2 clavicle fractures. Modern studies on primary plate fixation for acute midshaft clavicular fractures report union rates between 94% and 100% [10,12]. For instance, Robinson et al., in a randomized controlled trial (RCT), noted a non-union rate of only 1.2% in the ORIF group (i.e., one out of 86 patients) [13]. Similarly, Woltz et al. found a non-union rate of 2.4% (2/86) in their RCT [14]. The Canadian Orthopaedic Trauma Society also reported lower non-union rates (3%) and shorter times to union (16.4 weeks) in their comparative RCT [10]. Our study yielded comparable or better results than these studies, with all patients showing evidence of union on retrospective radiological evaluation and a mean time to union of 8.1 weeks. The overall satisfaction rate with the treatment was 84%, with most patients pleased with the cosmetic appearance of their shoulders. The patient-oriented functional outcome score (DASH) also indicated good results, aligning with findings from the previously mentioned RCTs [10,13,14]. Significant shortening of the clavicle (>2 cm) after non-union or malunion is a major cause of patient dissatisfaction. Shortening in the medial-lateral direction reduces the lever arm and strength of muscles primarily involved in abduction. Research has shown that clavicular shortening negatively affects shoulder abduction and forward elevation, and is linked to shoulder dyskinesia and altered scapular positioning [15-17]. Shortening greater than 14 mm in women and 18 mm in men has been associated with poorer functional outcomes and decreased shoulder strength [9,17]. In our view, ORIF with plate fixation restores the length and curvature of the clavicle, preventing non-union and shortening, thereby improving patient satisfaction and functional outcomes. The most common reason for implant removal was implant prominence and irritation, with a higher rate of removal in female patients. The reoperation rate was 26.67%, with implant failure occurring in 6.66% of cases within two months of the initial surgery. Leroux et al. reported a 24.6% reoperation rate in a cohort of 1350 patients who underwent ORIF with at least two years of follow-up, with implant removal being the most common cause of reoperation [18]. Naimark et al. reported a hardware removal rate of 12.7% in a cohort of 7826 patients [19]. Our study's reoperation rate is similar to that of the Leroux study but higher than that reported by Naimark.

A displaced midshaft clavicle fracture treated with open reduction and plate fixation generally results in a high likelihood of fracture healing and patient satisfaction, while also improving patient-centered functional recovery. The most common complication associated with this procedure is the need for reoperation due to symptomatic hardware. Patients who experienced complications had significantly lower scores on patient-oriented outcome measures compared to those who did not encounter complications.

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