Long-Term Functional Outcomes After Surgical Treatment of Displaced Midshaft Clavicle Fractures: A Retrospective Cohort Study

doi:10.21203/rs.3.rs-4901284/v1

Introduction:

Long-term studies on clavicle fractures are scarce, making new data in this field particularly valuable. This study aimed to assess long-term clinical and radiographic outcomes, as well as the quality of life in patients treated with pre-contoured plates for midshaft clavicle fractures, while identifying potential outcome-associated risk factors.

Methods:

Between 2010 and 2020, 91 patients with displaced midshaft clavicle fractures treated by open reduction and internal fixation with pre-contoured plates were identified from 987 cases. Seventy-six of these patients were prospectively reviewed to assess clinical status (using DASH, Constant score, and EQ-5D/EQ-VAS for quality of life) and hardware-related outcomes at the most recent follow-up.

Results:

At an average follow-up of 64 months (range: 39–179), patients reported excellent outcomes: a mean Constant score of 91, a QuickDASH of 0.3, an EQ-5D of 0.94, and an EQ-VAS of 81.5. Active forward flexion, abduction, and external rotation were 177º, 175º, and 60º, respectively. Hardware removal was required in 11% of patients, with 30.7% reporting discomfort. Complications were minimal (5.5%), including 2 cases of non-union, 2 superficial wound infections, and 1 partial wound dehiscence. No refractures were observed. There was no significant association between fracture pattern (AO classification) or vertical displacement and functional outcomes (p = .578; p = .137). However, postoperative lengthening showed a significant correlation with QuickDASH scores (p = .019). Patient characteristics (BMI, age, gender, sports participation, or occupation) were not significantly associated with functional outcomes, complications, or hardware removal (p > .05).

Conclusion:

Although preoperative fracture displacement and hardware removal were not linked to poorer functional outcomes, up to 30% of patients reported discomfort post-surgery. Despite this, their perceived quality of life remained high. These findings provide valuable insights into long-term outcomes for patients treated with pre-contoured plates, underscoring the need for ongoing follow-up in this population.

Level of evidence

Level III, Retrospective Cohort Design, Treatment Study.

Clavicle

Fracture

long term outcomes

Mid-shaft

Internal fixation

Pre-contoured plate

Hardware removal

Shortening

Clavicle shaft fractures account for 2.6%-5% of all fractures, with midshaft fractures making up 81% of these cases [1–2]. Due to their high incidence, these fractures are commonly encountered in daily orthopedic practice and have traditionally been viewed as minor injuries that almost always heal with non-operative treatment [3–4], regardless of displacement or the number of fragments. However, there is a growing consensus on the need for surgical intervention in cases with severe displacement [5–6], driven by recent studies showing non-union rates of 13%-15% [7–8] and malunion that can lead to functional impairments [9] after non-operative management.

Historically, the classic indications for operative treatment have included open fractures, compromised skin, neurovascular complications, or concurrent fractures of the scapular neck (floating shoulder) [10–11]. However, other factors such as fracture pattern, vertical displacement, and shortening are also critical for achieving better functional outcomes [9]. While many studies have explored the influence of these factors on functional outcomes following non-operative treatment, only a few [1, 12–13] have examined their impact on postoperative clinical outcomes and hardware failure.

Moreover, long-term follow-up studies on traumatic extra-articular shoulder pathologies, such as clavicle fractures, are rare [14–15]. Given that screw-plate fixation remains the surgical method of choice [16–17], the aim of this study was to identify the influence of fracture characteristics (type and displacement) and patient factors on plate osteosynthesis failure and long-term functional outcomes.

Study Design

After receiving approval from our institutional review board (IRB) (Hospital Clínico San Carlos internal code 21/006-E), we conducted a retrospective descriptive study in the Orthopaedic Surgery and Traumatology Department of a level-one trauma center. The study spanned from January 2010 to February 2020. All clavicle fractures treated surgically using open reduction and internal fixation (ORIF) were identified and reviewed.

Inclusion and Exclusion Criteria

The inclusion criteria were as follows:

Patients aged 18 years or older at the time of the fracture.

Traumatic fractures of the middle third of the clavicle (Allman classification Type I and Robinson classification Type II).

Availability of initial anteroposterior radiographs of both clavicles.

A minimum of 12 months of postoperative clinical and radiological follow-up at our center.

Exclusion criteria included:

Patients younger than 18 years at the time of the fracture.
Non-displaced fractures, pathological fractures, or concomitant fractures in the ipsilateral upper limb.
Patients with pre-existing motor deficits in the affected upper limb or functional deficits that could affect the accuracy of functional scores.
Patients with other injuries or conditions that prevent proper functional assessment, such as hospitalization in intensive care or spinal injury causing immobility.
Absence of preoperative anteroposterior radiographs of both clavicles.
Incomplete or insufficient postoperative follow-up (less than 12 months).

Out of 987 clavicle fractures identified over the ten-year period, 641 involved the middle third. Of these, 389 were treated surgically. After applying the exclusion criteria, 298 cases were removed: 104 were lost to follow-up, and 92 had less than 12 months of follow-up. Ultimately, 91 patients met all inclusion criteria and were included in the study. Of these, 76 patients returned to the hospital for the most recent functional evaluation (Fig. 1).

Surgical Procedure and Postoperative Protocol

All surgical procedures were performed by one of three senior shoulder surgeons. Patients were operated on in the beach chair position under general anesthesia and local block. The fractures were fixed using fluoroscopy-guided pre-contoured clavicular plates manufactured by Synthes (West Chester, PA, USA) or Acumed (Hillsboro, OR, USA) (Fig. 2). A superior surgical approach was used in all cases. In fractures with an oblique pattern, one or two anteroposterior screws (2.7 or 3.5 mm) were used to aid reduction. For small, comminuted fragments not amenable to lag screw fixation, one or two cerclage sutures were applied for temporary stabilization.

An anterosuperior plate was used in 12 cases, while a superior plate was employed in 79 patients. Postoperatively, a sling was applied for two weeks, with active mobilization of the hand, wrist, and pendular exercises permitted from the outset. Passive shoulder exercises were authorized at two weeks, with active exercises and full sling removal after one month. Weightlifting, resistance exercises, and resumption of sports activities were prohibited until three months post-surgery.

Functional and Radiographic Assessment

Follow-up was conducted at one, three, six, and twelve months postoperatively by orthopedic surgeons from the shoulder unit. A recent functional evaluation was performed at a mean follow-up of 64 months (range 39–179 months) on 76 patients, assessed independently by two examiners uninvolved in the surgical procedures. This evaluation included the Constant-Murley score [18], Quick-DASH score [19], visual analogue scale (VAS) for pain, and shoulder range of motion, measured with a standard goniometer. Abduction strength was objectively measured at 45º of abduction for 4 seconds using a Lafayette Manual Muscle Tester (Lafayette Instrument, Lafayette, IN, USA), recording the average maximum strength of three measures. Health-related quality of life (HRQoL) was assessed using the EuroQol 5 Dimensions (EQ-5D) and EQ-VAS, a visual analogue scale where patients rate their perceived health status from 0 (worst possible health status) to 100 (best possible health status).

Clinical healing and scapular dyskinesia were also recorded. Clinical healing was defined as the point at which the patient no longer experienced pain during shoulder movement or palpation at the fracture site. Time until resumption of sports and work activities was also documented.

Radiographic assessments were performed by the same independent examiners using anteroposterior views of both clavicles. Preoperative evaluation included fracture classification according to the AO, Allman [20], and Robinson [21] classifications, as well as vertical displacement (measured between both fracture sides) [22] and clavicle shortening (measured as the difference between the contralateral healthy clavicle and the fractured clavicle on anteroposterior x-rays) (Fig. 3). Postoperative radiographs were reviewed to measure the restored clavicle length (difference between the preoperative non-injured clavicle and the postoperative injured clavicle), radiographic union time (complete cortical bridging between the proximal and distal fragments on both anteroposterior and axial views), and delayed union or non-union (defined as at least three months without clinical or radiographic progression of healing).

Complications, including symptomatic non-union or malunion, peri-implant fracture, infection, discomfort, and removal of osteosynthesis material, were also recorded.

Statistical Analysis

Qualitative variables were described by percentage and distribution proportions, while quantitative variables were summarized with mean and standard deviation or interquartile range. Statistical analysis was performed using SPSS 21.0 software. The Chi-Square test or Fisher’s exact test (when expected frequency was less than five in more than 25% of the variables) was used to evaluate the association of qualitative variables. Continuous variables with a normal distribution were compared using Analysis of Variance (ANOVA), while non-parametric variables were compared with the Kruskal-Wallis test. Pearson's correlation coefficient was employed to evaluate the linear relationship between continuous quantitative variables. A significance level of 5% was considered valid for all tests. To quantify the association between radiological clavicle lengthening and functional outcomes (Constant and Quick-DASH scores), a linear regression model was applied.

Epidemiological and Surgical Data

The study included 91 patients, 88% of whom were male, with a mean age of 39 ± 15.11 years. The dominant arm was affected in 42.8% of cases. Most patients (92%) were healthy without comorbidities, although 22 were smokers. At the time of the fracture, 64.8% (59 patients) were employed in administrative jobs, and 48.3% (44 patients) regularly engaged in sports, with 5 participating at a competitive level and 14 specifically involved in overhead sports.

The most common cause of fractures was sports trauma (36.3%), and the most frequent fracture type was AO 15.2B and 2B1 Robinson. Five patients presented with segmental midshaft fractures. Epidemiological data are summarized in Table 1.

Table 1

Epidemiological results. Results are expressed as mean and standard deviation except for median length stay which is expressed as 50th percentile and interquartile range. In brackets, the percentage of total N is expressed.
Epidemiological results	n = 91
Age (years)	39 (SD 15.11)
Gender (Male / Female)	71 / 20 (78/22)
BMI*	25 ± 4
Fracture side (Right / Left)	38 / 53 (42/58)
Dominant side (Yes / No)	39 / 52 (43/57)
Smoker (Yes / No)	22 / 69 (24/76)
Alcoholism (Yes / No)	9 / 82 (10/90)
Comorbidities (Yes / No)	84 / 7 (92/8)
Work (Physical / Administrative)	32 / 59 (35/65)
Sports · Yes · No · Overhead	44 (48) 47 (52) 14 (15)
Mechanism of injury · Sports · Motorcycle crash · Casual fall · Red code politrauma · Others	33 (36) 28 (31) 21 (23) 5 (5) 4 (4)
AO Fracture pattern · 15.2A · 15.2B · 15.2C	22 (24) 36 (40) 33 (36)
Robinson Fracture pattern · 2A1 · 2A2 · 2B1 · 2B2 · 2B3	1 (1) 3 (3) 47 (52) 36 (39) 4 (4)
Segmental fracture (Yes / No)	5 / 86 (5/94)
Time to surgery (days)	10.4 ± 7.2
Hospital stay** (days)	1 (1–2)
Follow up (months)	64 ± 33

Clinical Outcomes

A follow-up evaluation was conducted in 76 out of 91 patients at an average of 64 months (range 39–179 months). Clinical union, as defined previously, was observed at an average of 2.75 months (SD 1.722). The average active shoulder range of motion was 177º ± 6º for forward flexion, 175º ± 10º for abduction, and 60º ± 11º for external rotation, with internal rotation reaching above the 11th dorsal vertebra in 52 patients. No scapular dyskinesia was detected. A significant majority, 92.1%, reported returning to their pre-injury physical activities within the first six months post-surgery. The mean scores were as follows: Constant score 91 ± 7, Quick-DASH 0.3 (range 0-2.26), EQ5D 0.94, EQVAS 81.5, and VAS 1.2 (range 1–3). Functional and quality of life outcomes are detailed in Table 2.

Table 2

Clinical Outcomes. Results are expressed as mean and standard deviation. In brackets, the percentage of total N is expressed.
Clinical Outcomes
N	76
Clinical healing (months)	2.75 ± 1.72
Shoulder ROM Anteversion Abduction External rotation Internal rotation • Bellow D11 vertebra • Above D11 vertebra	177º± 6 176º±10 59 ± 11 39 (43) 52 (57)
Constant Score	91 ± 7
Quick -DASH Score	0.3 (0-2.26)
VAS	1.2 (1–3)
EQ5D	0.94 (1–3)
EQVAS	81.5 ± 14.4
ROM: Range of Motion

Table 2. Clinical Outcomes. Results are expressed as mean and standard deviation. In brackets, the percentage of total N is expressed.

ROM: Range of Motion

A multivariate analysis found no significant association between fracture pattern (as per AO classification) and functional outcomes (Constant and Quick-DASH scores) (p = .218; p = .630). Similarly, no significant relationship was identified between preoperative vertical displacement and clinical outcomes (Constant and Quick-DASH scores) (p = .578; p = .137). However, there was a statistically significant correlation between postoperative clavicle lengthening and Quick-DASH scores. Specifically, each centimeter of shortening correction improved the Quick-DASH score by 1.5 points, indicating better functional outcomes (p = .019). Table 3 summarizes factors associated with functionality scores.

Table 3

Factors associated with functional scores (Quick Dash and Constant score). *Statistical significance result.
Factors associated with functional scores	p – value
Gender • Quick Dash • Constant	.426 .148
AO Fracture pattern • Quick Dash • Constant	.218 .630
Hardware removal • Quick Dash • Constant	.432 .967
Lengthening • Quick Dash • Constant	.019* .140
Vertical displacement • Quick Dash • Constant	.578 .137

Radiological Outcomes

All fractures healed, except for two cases, with a mean healing time of 5 ± 2 months. The mean preoperative vertical displacement was 5 mm (range 2–8 mm), and the mean preoperative shortening was 23 mm (range 7–31 mm). Post-surgery, the mean clavicle lengthening was 17.23 mm (SD 14.24). Postoperatively, 89 cases had residual shortening of less than 5 mm, 1 case had residual shortening between 5–10 mm, and 1 case had more than 10 mm, the latter two being cases of non-union.

Complications

No intraoperative complications were reported. The postoperative complication rate was 5.5% (5 cases). Two patients experienced non-union, requiring revision surgery with double plating and iliac crest bone autograft, both of which eventually healed. Two cases of superficial wound infections required oral antibiotics, and one patient had partial wound dehiscence. Additionally, there were 7 cases (7.7%) of keloid scars and 6 patients (6.5%) reported hypoaesthesia at the surgical site. No re-fractures occurred during follow-up.

Twenty-eight patients (30.7%) reported discomfort from the osteosynthesis material, leading to hardware removal in 10 patients (11%) at an average of 14 ± 7.81 months post-surgery. There was no significant association between hardware removal or other complications and patient or fracture characteristics (age p = .288; sex p = .126; BMI p = .531; job p = .131; overhead sports p = .356; competition sports p = .283). Functional and quality of life outcomes for patients who had hardware removal were as follows: Constant score 94.4 ± 4, Quick-DASH 1, EQ5D 0.94, EQVAS 81.11, and VAS 1.66. No statistically significant differences were found compared to patients who did not undergo hardware removal (p > .05). Additionally, no statistical differences in Constant and Quick-DASH scores were observed before and after hardware removal (p = .156; p = .214).

Historically, Neer and Rowe's studies from the 1960s advocated for non-operative management of clavicular fractures, regardless of displacement [3, 4]. However, these studies have been criticized for including heterogeneous populations and lacking rigorous long-term functional assessments. Recent research indicates that non-operative treatment may result in higher non-union rates and poorer functional outcomes compared to surgical intervention [6–7, 9, 12–13, 23–25]. Plate fixation has emerged as the gold standard for managing displaced midshaft clavicle fractures, offering a rigid construct with low implant failure rates. However, the complexity of the clavicle's anatomy and its subcutaneous position contribute to a higher incidence of hardware removal [26–29].

The present study reinforces the predominance of surgical intervention in younger male patients (mean age 39 years), aligning with other reports in the literature [29]. Notably, 14% of the surgical cases involved patients aged 18 to 22, reflecting the increasing preference for surgical management in younger individual’s contrary to the traditional tendency [30], possibly due to demands for quicker return to sports and aesthetic considerations.

Fracture pattern and displacement has been previously studied as a predictor factor of conservative treatment failure (persisting pain, non-union, and dysfunction) [5, 7, 16, 25, 31–33] however, only a few studies analyse the influence of fracture displacement in plate osteosynthesis failure [34]. The amount of shortening required to affect clinical outcomes remains uncertain and most of the studies that conclude on clavicle shortening and functional outcomes are in groups of patients treated conservatively. Shortening ≥ 20 mm has been reported by several authors [1, 5, 7, 16] to be related to worse functional results after conservative treatment. Other authors have set the shortening limit even lower (15 mm). [9, 25] According to sex, Zlowodzki et al, [33] differentiated the limit of shortening associated with an unsatisfactory result at 18 mm in male patients and 14 mm in female patients. Although measurement of shortening has been the subject of debate, we measured clavicle shortening from the contralateral clavicle length measurement, as a parameter of normal length like Lazarides et al, [32] assuming that both clavicles were equal in length, although an asymmetry has been published between both clavicles of 5 mm or more in 30% of patients [35].

We observed a statistically significant correlation between postoperative clavicular lengthening and improved functional outcomes, as measured by the Quick-DASH score. Specifically, each centimeter of corrected shortening was associated with a 1.5-point decrease in the Quick-DASH score, highlighting the importance of achieving anatomic restoration during surgery. Interestingly, while previous studies have linked greater vertical displacement with poorer outcomes in conservatively treated fractures [15, 36–37], our study did not find such an association in surgically managed cases. This suggests that surgical intervention may mitigate the impact of initial fracture displacement on long-term functionality.

Previous studies have also reported a significant association between fracture type and functional outcomes after conservative treatment, with Constant score worsening with higher comminution of the fracture [9]. Champochiaro et al [38] did not find any association between fracture type (Robinson classification) and the Constant and DASH score. Similarly, no association between functional outcome (Constant/Quick-DASH) and fracture pattern was found in the present series. Despite the degree of comminution of the fracture and vertical displacement, the length of the clavicle was restored with < 5mm difference with respect to the uninjured clavicle in 97.8% (89 cases).

The rate of hardware removal in our study was 11%, lower than the range reported in other series [13, 24]. This may be attributed to the use of pre-contoured plates and meticulous surgical technique. Despite this, 30% of patients reported some degree of discomfort related to the hardware, underscoring the ongoing challenge of balancing rigid fixation with patient comfort. Importantly, functional outcomes were not significantly different between patients who underwent hardware removal and those who did not, indicating that hardware removal does not necessarily lead to functional improvement.

Rates of clavicle refracture or bend and refracture after plate removal are around 7%-10%, [28] but we did not find any refracture. There is no special protocol in our centre for patients with hardware removal, they are only advised to avoid practising contact sports for three months after plate removal.

We found 2 cases of non-union (2.19%). The rate of non-union with orthopaedic treatment ranges between 5%-20%, [7,9,15,36,40] being significantly higher than with surgical treatment, which is usually under 5%. [9,15,40] Clavicle shortening has been reported as a risk factor of non-union [7, 16] with conservative treatment. Related to surgery, we did not identify any patient-related factor associated with the presence of non-union (BMI, smoking, sports, or type of job) probably because, given the low rate of this complication, a much higher number of non-unions would be necessary to establish a causal relationship.

Our study's long-term follow-up, with a mean of 64 months, is a significant strength, providing valuable insights into the durability of functional outcomes and patient satisfaction over time. The high degree of patient satisfaction, as reflected by the EQD5 and EQVAS scores, contrasts with reports from non-operative treatment studies where a substantial proportion of patients did not feel fully recovered even after long-term follow-up [39].

However, the present study is not without limitations. The retrospective design and the absence of a control group (conservatively treated patients) limit the generalizability of our findings. Additionally, the use of simple X-rays for measuring clavicular length, rather than more precise imaging modalities like CT, and the assumption of bilateral clavicle symmetry, may introduce measurement bias.

Long-term follow-up demonstrated that restoring clavicular length through surgical intervention is crucial for optimal functional recovery, with each centimeter of corrected shortening significantly improving functional outcomes. Importantly, preoperative fracture displacement (both shortening and vertical displacement) did not negatively impact long-term functionality, reinforcing the effectiveness of surgical correction. Although a portion of patients reported hardware-related discomfort, their overall quality of life remained high, emphasizing the benefits of plate fixation. This study underscores the importance of achieving precise anatomical restoration in displaced midshaft clavicle fractures to ensure favorable long-term outcomes.

Acknowledgements

None.

Authors

Lopiz Morales, Yaiza MD, PhD; Rodriguez-Zamorano, Patricia MD; Diz Diaz, Macarena MD; García-Fernandez, Carlos MD, PhD; Marco, Fernando MD, PhD.

Author contributions

YL designed the protocol, YL and PR wrote the main manuscript text. MD, CGF prepared the tables and collected most of the data. YL and PR analyzed the stats. FM and YL contributed to the literature search and made the revisions. All authors reviewed the manuscript.

Funding

No funding.

Data availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Clinical trial number: not applicable

Human Ethics and Consent to Participate declarations was obtained from the Research This study was approved by the institutional review board (IRB) of Clínico San Carlos University Hospital (internal code 21/006-E). Clinical information was obtained from medical management systems of hospital. All methods were carried out in accordance with the Declaration of Helsinki. Informed consent was obtained from all patients and/or their legal guardian(s).
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Conflict of interest
None.

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No competing interests reported.

Long-Term Functional Outcomes After Surgical Treatment of Displaced Midshaft Clavicle Fractures: A Retrospective Cohort Study

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Version 1

Abstract

Introduction:

Methods:

Results:

Conclusion:

Level of evidence

Figures

INTRODUCTION

MATERIAL AND METHODS

Study Design

Inclusion and Exclusion Criteria

Surgical Procedure and Postoperative Protocol

Functional and Radiographic Assessment

Statistical Analysis

Results

Epidemiological and Surgical Data

ROM: Range of Motion

Radiological Outcomes

Complications

DISCUSSION

CONCLUSIONS

Declarations

References

Additional Declarations

Status:

Version 1