Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study

Study design

This prospective observational study was conducted at the Department of Orthopedics, Al-Thawra Modern General Hospital, and Kuwait University Hospital, Sana’a, Yemen, between January 2018 and September 2024. The primary aim of this study was to assess the functional outcomes of displaced midshaft clavicular fractures treated with open reduction and internal fixation (ORIF) using pre-contoured superior clavicle locking plates. A standardized protocol governed patient selection, surgery, postoperative care and follow-up to ensure consistency. Data were collected prospectively.

Study population

Eligible patients were adults (≥18 years) with closed, displaced midshaft clavicular fractures, defined as displacement >2 cm, shortening >2 cm, comminution, or skin tenting threatening viability. The exclusion criteria were open or pathological fractures, proximal or distal third clavicle involvement, head or neurovascular injuries, acromioclavicular dislocations, and prior nonunion. All participants provided written informed consent.

Sample size

The sample size was calculated based on the primary outcome, the University of California, Los Angeles (UCLA) Shoulder Score. The calculation aimed to ensure sufficient power to detect a clinically meaningful outcome. Based on a Minimal Clinically Important Difference (MCID) of approximately 4 points for the UCLA score (standard deviation 5), as suggested by prior literature on shoulder pathology,^8,9 we determined that a minimum of 33 patients would be required to achieve 90% power with α = 0.05. To account for potential dropouts and to enhance the power for subgroup analyses, we aimed for a larger cohort and ultimately enrolled 65 patients.

Surgical technique

Preoperative workup included standard blood tests and clavicular radiographs (anteroposterior, 20° cranial tilt). Under general anesthesia, the patients were positioned in a beach-chair setup with a scapular sandbag for reduction. Prophylactic antibiotics were administered before the incision. A transverse incision below the fracture exposed the clavicle via superior retraction, thereby avoiding wound overlap with the plate. Subcutaneous tissue and platysma were mobilized together, myofascial layers were incised, and soft tissues were elevated, preserving supraclavicular nerves unless exposure demanded sacrifice. Fracture reduction was performed using clamps or indirect techniques, as confirmed by fluoroscopy. A 3.5-mm titanium precontoured locking plate (Orthomed E, Egypt) was fixed anterosuperiorly with locking screws, ensuring a minimum of three bicortical screws (i.e., six cortices) per main fragment; lag screws were used to address butterfly fragments as needed. The fascia was repaired over the plate, the skin was closed in layers, and the arm was slung postoperatively.

Postoperative care and follow-up

Patients received analgesics, postoperative radiographs, and sling immobilization for 4 weeks with pendulum exercises. Follow-ups at 10 days (suture removal), 4, 8, 12, and 26 weeks included a rehabilitation protocol starting week 4 (active-assisted motion, progressing to full range by week 8). UCLA scores were assessed at 6 months by two orthopedic surgeons, with inter-rater reliability assessed. Radiographic union was monitored descriptively by the treating surgeon, with delayed union defined as a lack of three-cortex bridging at 12 weeks.

Outcome measures

The primary outcome was functional recovery assessed using the UCLA Shoulder Score (max 35), evaluating pain (0–10), function (0–10), active forward flexion (0–5), strength (0–5), and satisfaction (0–5).¹⁰ Scores ≥27 indicated good/excellent outcomes, and <27 fair/poor. Preoperative scores were not recorded; however, pre-injury shoulder function was queried to exclude prior pathology. UCLA scores were calculated using the MDCalc online tool (MDCalc UCLA Shoulder Score Calculator). The secondary outcomes included complication rates (hardware irritation, failure, infection, delayed union, and malunion).

Bias control and variability management

To minimize bias, UCLA Shoulder Scores were independently assessed by two orthopedic surgeons who were uninvolved in patient treatment. Inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC). Based on established guidelines, an ICC ≥0.80 indicates good reliability. Discrepancies greater than 2 points were reviewed by a third evaluator, and final scores were determined by consensus. Variability control was ensured through a standardized sample size calculation, a uniform follow-up schedule (10 days, 4, 8, 12, and 26 weeks), and a consistent rehabilitation protocol. All procedures followed a predefined surgical technique using precontoured superior clavicle locking plates, minimizing technical variations.

Statistical analysis

Data were analyzed using SPSS version 26. Descriptive statistics summarized demographic characteristics, injury details, and outcomes (mean ± SD for continuous variables; frequencies/percentages for categorical variables). Normality was assessed using the Shapiro-Wilk test. Given the non-normal UCLA score distribution, nonparametric tests (Kruskal-Wallis, Mann-Whitney U) were used to assess subgroup differences. Chi-square tests were used to examine complication associations, and Spearman’s correlation was used to evaluate age-outcome links.

Demographic and injury characteristics

Sixty-five patients with displaced midshaft clavicular fractures treated with precontoured locked plates were enrolled. The mean age was 32.09 years (range: 19–50 years), with 54 males (83.1%) and 11 females (16.9%). Road traffic accidents (RTAs) caused the most injuries (n=43, 66.2%), followed by falls (n=22, 33.8%). The right clavicle was affected in 43 (66.2%) patients and the left clavicle in 22 (33.8%). Table 1 details these traits, and Figures 1–2 show representative cases.

Figure 1. Pre- and postoperative radiographs of a 30-year-old male with displaced midshaft clavicle fracture.

(a) Preoperative anteroposterior radiograph showing a displaced, slightly comminuted midshaft fracture of the right clavicle in a 30-year-old male patient. (b) Postoperative anteroposterior radiograph of the same patient following open reduction and internal fixation (ORIF) with a pre-contoured superior locking plate (Orthomed E, 7-hole, titanium). Note the anatomical reduction of the fracture and the use of locking screws that engage at least four cortices on either side of the fracture.

Figure 2. Pre- and postoperative radiographs of a 26-year-old female with comminuted midshaft clavicle fracture.

(a) Preoperative anteroposterior radiograph showing a displaced, severely comminuted midshaft fracture of the right clavicle in a 26-year-old female patient. (b) Postoperative anteroposterior radiograph of the same patient following open reduction and internal fixation (ORIF) with a pre-contoured superior locking plate (Orthomed E, 8-hole, titanium). Note the anatomical reduction of the fracture and the use of locking screws that engage at least four cortices on either side of the fracture. Two lag screws were used to stabilize the butterfly fragments.

Functional and radiographic outcomes

At 6 months, the mean UCLA shoulder score was 32.46 ± 2.54, with 64 patients (98.5%) achieving good/excellent outcomes (UCLA ≥27) and 1 (1.5%) fair/poor (<27). Table 2 summarizes the scores, and Supplementary Table S1 breaks down the components (Extended Data). Radiographs confirmed union in all cases by 12 weeks (three-cortex bridging), with no delayed unions or malformations noted.

Patient satisfaction

All 65 patients (100%) reported satisfaction with surgical outcomes, reflected in the UCLA Shoulder Rating Score satisfaction component (all scored 5, “Satisfied and better”; Supplementary Table S1(Extended Data)).

Postoperative complications

Complications were rare and included hardware irritation (n=1, 1.5%), hardware failure (n=2, 3.1%), and superficial infection (n=1, 1.5%), totaling 6.2% of patients. No delayed unions, malunions, or refractures occurred, and 61 patients (93.8%) were complication-free. Table 3 presents the outcomes.

Subgroup and correlation analyses

UCLA scores and patient characteristics

To assess differences in total UCLA scores across subgroups, we performed Kruskal-Wallis tests for age groups (more than two categories) and Mann-Whitney U tests for sex, injury mechanism, and injured side (two categories each). Spearman’s rank-order correlation was used to examine the relationship between age (a continuous variable) and total UCLA scores. The results are summarized in Table 4.

A statistically significant negative correlation was found between age and the total UCLA score (ρ = -0.317, p = 0.010), indicating that older patients tended to have lower UCLA scores. Significant differences in the total UCLA scores were also found based on the mechanism of injury (p = 0.029) and the injured side (p < 0.001). Patients with RTA injuries had higher UCLA scores than those with falls, and those with right-sided injuries had higher UCLA scores than those with left-sided injuries. No significant differences were observed according to sex.

UCLA component scores and age

Kruskal-Wallis tests revealed significant differences across age groups for the pain score (p=0.001) and active forward flexion (p=0.013). Post-hoc tests indicated that the 41-50 age group had significantly better scores (less pain and better flexion) than the 18-30 age group. No significant differences were observed between the age groups in terms of the function, strength, or satisfaction components of the UCLA score.

Complications and patient characteristics

Chi-square tests of independence were performed to examine the relationship between categorical variables (age group, mechanism of injury, sex, injured side, and UCLA outcome category) and the occurrence of complications. The results are summarized in Table 5. A statistically significant association was found between UCLA outcome category and complications (p < 0.001), with patients experiencing complications having worse outcomes, as expected. The Mann–Whitney U test revealed a statistically significant difference in the total UCLA scores between patients with and without complications (U = 11.000, p < 0.001). Patients with complications had significantly lower UCLA scores than those without complications. Although not statistically significant at p < 0.05, there were trends suggesting possible associations between age group (p=0.051, with a significant linear association p=0.046), mechanism of injury (p=0.073), and injured side (p=0.073) with complication rates.

Limitations

This study has several limitations that limit its conclusions. Foremost, the absence of a control group—whether nonoperative management or alternative fixation (e.g., intramedullary nailing)—precludes definitive claims about the superiority of precontoured locked plate fixation despite its promising outcomes. The 6-month follow-up period captures early recovery but misses critical long-term outcomes, such as hardware removal rates, refracture, and chronic dysfunction, which undermine durability assessments. Geographic confinement to two Sana’a, Yemeni centers restricts generalizability, as resource availability and patient profiles may differ elsewhere. Pre-injury UCLA scores were not recorded, which hindered the direct measurement of functional gains. Additionally, the 100% satisfaction rate suggests potential reporting bias or that an insufficiently granular metric—an alternative tool (e.g., DASH) might reveal variability. These constraints underscore the preliminary nature of our findings and warrant caution. Additionally, the reported 100% patient satisfaction rate, measured via the single-item component of the UCLA score, should be interpreted with caution. This finding is likely a reflection of the tool’s limited granularity rather than a perfect outcome for every patient. Even those with minor, resolvable complications may have reported overall satisfaction relative to their pre-operative condition. This suggests a potential reporting bias, and future studies should employ more comprehensive patient-reported outcome measures, such as the DASH (Disabilities of the Arm, Shoulder and Hand) score, to capture a more nuanced view of patient satisfaction. Third, while our overall sample size was robust, the subgroup analyses (e.g., by age group) were based on smaller numbers, which limits the statistical power to detect true differences and increases the risk of a Type II error. The findings from these subgroup comparisons should therefore be considered exploratory.

Larger multicenter studies with longer follow-up periods and control groups are needed to confirm these results and assess long-term efficacy. Exploring subgroup differences (e.g., age, mechanism, and laterality) using biomechanical and patient-reported data could refine treatment strategies.

Ethical approval and consent

This study was conducted in accordance with the ethical standards of the Institutional Review Board (IRB) of Al-Thawra Modern General Hospital, Sana’a, Yemen, and adhered to the principles of the Declaration of Helsinki (1964) and its later amendments. Ethical approval was obtained from the IRB of Al-Thawra Modern General Hospital before the commencement of the study (Reference Number: IRB-TMGH-2017-047; Approval Date: 15 November 2017). Written informed consent was obtained from all participants prior to their inclusion in the study. Participants were informed about the study’s purpose, procedures, potential risks, and benefits, and their consent was documented. Additionally, all participants provided written consent for the publication of their anonymized data, including radiographic images, after reviewing a summary of the study contents.

Patients consent

All participants provided written consent for publication of their anonymized data, including images, after reviewing a summary of the study contents.