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

Study design

This prospective observational cohort study was conducted according to the STROBE guidelines at two centers in Sanaa, Yemen between January 2018 and September 2024. The study protocol was standardized to ensure consistency in patient selection, surgical techniques, postoperative care, and follow-up procedures.

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 non-union. All the participants provided written informed consent. These inclusion criteria were selected because they represent established indications for surgical intervention associated with a higher risk of poor outcomes when managed nonoperatively.

Sample size

The sample size was calculated based on the primary outcome of the University of California, Los Angeles (UCLA) Shoulder Score. This calculation aimed to ensure sufficient power to detect clinically meaningful outcomes. 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,^14,15 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 of subgroup analyses, we aimed for a larger cohort and ultimately enrolled 65 patients.

Surgical technique

The 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 incision. A transverse incision below the fracture exposed the clavicle via superior retraction, thereby avoiding a wound overlap with the plate. The subcutaneous tissue and platysma were mobilized together, myofascial layers were incised, and soft tissues were elevated, preserving supraclavicular nerves unless exposure required sacrifice. Fracture reduction was performed using clamps or indirect techniques, as confirmed using 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 slung postoperatively.

Postoperative care and follow-up

The patients received analgesics, postoperative radiographs, and sling immobilization for 4 weeks. The structured rehabilitation protocol was as follows:

Follow-ups at 10 days (suture removal), 4, 8, 12, and 26 weeks were performed. UCLA scores were assessed at 6 months by two orthopedic surgeons, and inter-rater reliability was 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).¹⁶ Scores ≥27 indicated good/excellent outcomes, and <27 fair/poor outcomes. Preoperative scores were not recorded; however, pre-injury shoulder function was queried to exclude any prior pathology. We used the original English version of the score, which was administered verbally by surgeons fluent in both English and Arabic. We acknowledge that a formally validated Arabic translation was not used, which is a limitation of this study. UCLA scores were calculated using the MDCalc online tool (MDCalc UCLA Shoulder Score Calculator). Secondary outcomes included complication rates (hardware irritation, failure, infection, delayed union, and malunion).

Bias control and variability management

To minimize bias, the 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 of ≥0.80 indicates good reliability. Discrepancies greater than 2 points were reviewed by a third evaluator, and the final scores were determined by consensus. Variability control was ensured through a standardized sample size calculation, uniform follow-up schedule (10 days, 4, 8, 12, and 26 weeks), and consistent rehabilitation protocol. All procedures followed a predefined surgical technique using precontoured superior clavicular locking plates, minimizing technical variations.

Statistical analysis

Data were analyzed using SPSS version 26 (IBM Corp., Armonk, NY, USA). Descriptive statistics were used to summarize demographic characteristics, injury details, and outcomes. Normality was assessed using the Shapiro-Wilk test. Given the non-normal UCLA score distribution, nonparametric tests (Kruskal-Wallis Mann and–Whitney U) were used to assess subgroup differences. Chi-square tests were used to examine the association between complications, and Spearman’s correlation was used to evaluate the relationship between age and UCLA scores. A p-value <0.05 was considered statistically significant.

Patient enrollment

During the study period, 78 patients with midshaft clavicular fractures were assessed for eligibility to participate. Thirteen patients were excluded because of open fractures (n=7), associated neurovascular injuries (n=4), or declining consent (n=2). The final cohort consisted of 65 patients who met all inclusion criteria and underwent surgical fixation. All 65 enrolled patients completed the 6-month follow-up and were included in the final analysis ( Figure 1).

Figure 1. Flowchart of patient enrollment.

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 2 and 3 show representative cases.

Figure 2. 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 after open reduction and internal fixation (ORIF) with a precontoured 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 3. Pre- and postoperative radiographs of a 26-year-old female with comminuted midshaft clavicular 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 after open reduction and internal fixation (ORIF) with a precontoured 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.

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%) in 6.2% of patients. No delayed unions, malunions, or re-fractures occurred, and 61 patients (93.8%) were complication-free. Table 3 presents the study outcomes are presented in Table 3.

Subgroup and correlation analyses

UCLA scores and patient characteristics

To assess the 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 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 the 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 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, 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. 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 of p=0.046), mechanism of injury (p=0.073), and injured side (p=0.073) with complication rates.

Limitations

This study had several limitations that limited 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 and Yemeni centers restricts generalizability, as resource availability and patient profiles may differ elsewhere. Pre-injury UCLA scores were not recorded, hindering the direct measurement of functional gains. Additionally, the 100% satisfaction rate suggests a 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 further caution. Additionally, the reported 100% patient satisfaction rate, measured using 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 report overall satisfaction relative to their preoperative 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 Type II error. Furthermore, the low number of complication events (n=4) precluded meaningful multivariate logistic regression analysis to identify independent predictors. Therefore, the findings of these subgroup comparisons should be considered as exploratory.

Larger multicenter studies with longer follow-up periods and control groups are needed to confirm these results and assess their 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: November 15, 2017). Written informed consent was obtained from all the participants prior to their inclusion in the study. The participants were informed about the study’s purpose, procedures, potential risks, and benefits, and their consent was documented. Additionally, after reviewing a summary of the study contents, all participants provided written consent for the publication of their anonymized data, including radiographic images.

Patients consent

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