Revised: July 17, 2026
Accepted: August 14, 2026
Published online: September 18, 2026
Processing time: 83 Days and 18.4 Hours
The optimal management of displaced midshaft clavicle fractures in adults rema
To compare operative vs nonoperative outcomes, union rates, and complications in adults with displaced midshaft clavicle fractures.
A systematic review was conducted in accordance with PRISMA 2009 guidelines and registered on PROSPERO (CRD420261328668). PubMed, EMBASE, Scopus, and Web of Science were searched for randomized controlled trials and comparative studies published from January 2000 to June 2026. Eligible studies included adults with acute displaced midshaft fractures and reported union rates and/or functional outcomes, including Disabilities of the Arm, Shoulder and Hand and Constant scores.
A total of 15 studies involving 1615 patients were included. Operative fixation was associated with significantly lower nonunion rates (0%-5%) compared with nonoperative treatment (6%-24%). Although early functional scores were superior in the surgical group, these differences generally diminished by 12 months of follow-up in most studies. Surgical complications were primarily hardware-related, with reported rates of up to 27%, whereas nonoperative treatment was associated with higher rates of symptomatic malunion and nonunion.
Operative fixation significantly reduces the risk of nonunion and accelerates functional recovery in adults with displaced midshaft clavicle fractures. However, long-term functional outcomes remain equivalent to those observed with nonoperative management.
Core Tip: This systematic review of level I evidence evaluated operative fixation vs nonoperative management for displaced midshaft clavicle fractures in 1615 patients. Our findings demonstrate that while surgery significantly reduces the risk of nonunion and facilitates earlier functional recovery, long-term functional outcomes at 1 year are generally comparable between operative and nonoperative management. These results emphasize the need for individualized, patient-centered decision-making, particularly for active adults who prioritize a rapid return to function.
- Citation: Munshi AA, Abdulaziz AA, Tamim HH, Alghamdi GA, Halawani AF, Alsawaf AH, Alghamdi AA, Alqurashi AI, Altowairqi MY, Alnofeay KA. Operative vs nonoperative management of displaced midshaft clavicle fractures: A systematic review. World J Orthop 2026; 17(9): 124549
- URL: https://www.wjgnet.com/2218-5836/full/v17/i9/124549.htm
- DOI: https://dx.doi.org/10.5312/wjo.124549
Clavicle fractures are among the most frequent injuries of the upper extremity, accounting for approximately 2.6% to 4% of all adult fractures and up to 44% of shoulder-girdle injuries[1,2]. The midshaft region is particularly vulnerable, representing nearly 80% of clavicle fractures due to the bone’s S-shaped curvature and the mechanics of load transfer across the middle third[1]. These injuries commonly follow high-energy trauma in younger adults, such as road traffic incidents and contact sports, or low-energy falls in older adults, with significant implications for treatment choice and functional outcomes[3].
Historically, nonoperative management with a simple sling or figure-of-eight bandage was considered the standard of care, supported by early case series reporting high union rates and acceptable functional outcomes[4]. However, this paradigm has shifted over the past two decades. Accumulating evidence suggests that nonoperative treatment of dis
A landmark multicenter randomized controlled trial (RCT) conducted by the Canadian Orthopaedic Trauma Society (COTS) demonstrated that plate fixation for completely displaced midshaft fractures significantly improved early functional outcomes and reduced the rate of nonunion compared with nonoperative treatment[6]. Subsequent ran
Contemporary clinical guidelines recommend individualized, patient-centered decision-making that incorporates fracture displacement, comminution, patient age, activity level, and personal preferences[11,12].
Given the ongoing debate regarding the necessity of surgery, particularly concerning long-term functional equivalence, this review aims to synthesize the current high-quality evidence comparing operative vs nonoperative management of adult midshaft clavicle fractures.
This systematic review was conducted in accordance with the PRISMA 2009 guidelines. The study protocol was prospec
A comprehensive literature search was performed across PubMed, EMBASE, Scopus, and Web of Science databases to identify studies published between January 1, 2000, and June 30, 2026. The comprehensive electronic search strategy was executed using the following reproducible Boolean architecture: “Clavicle”[MeSH] OR “clavicle/injuries”[MeSH] OR “clavicle fracture” OR “midshaft clavicle” AND “fracture fixation, internal”[MeSH] OR “bone plates”[MeSH] OR “operative” OR “surgical” OR “plate fixation” OR “intramedullary nail” AND “conservative treatment”[MeSH] OR “nonoperative” OR “conservative” OR “sling” OR “figure-of-eight”. In addition, the reference lists of all included studies and relevant review articles were manually screened to identify any additional eligible studies.
Studies were selected according to predefined inclusion and exclusion criteria based on the Population, Intervention, Comparison, Outcomes, and Study design framework. This review included studies involving skeletally mature adults (aged 18 years or older) with acute, completely displaced midshaft clavicle fractures. The intervention of interest was surgical fixation using either plate osteosynthesis or stable intramedullary fixation devices. This approach was directly compared against conservative, nonoperative management strategies utilizing a standard arm sling or a figure-of-eight supportive bandage. To be eligible for inclusion, studies were required to report primary or secondary clinical endpoints, specifically radiographic union or nonunion development, symptomatic malunion rates, objective functional performance scores measured via the Disabilities of the Arm, Shoulder and Hand (DASH) or Constant scales, timelines for return to work or prior activity levels, and overall postoperative or post-treatment-related complications.
Eligible study designs included RCTs, controlled clinical trials (CCTs), and prospective or retrospective comparative cohort studies. To eliminate confounding patient variables and ensure the inclusion of high-quality evidence, studies involving pediatric or adolescent populations, pathological fractures secondary to underlying malignancy or bone disease, and specialized biomechanical or cadaveric models were excluded. Furthermore, to maintain statistical relevance and comprehensive data quality, case series with fewer than 10 patients and studies published in languages other than English were excluded from the final analysis.
Two reviewers, working independently, screened the titles and abstracts of all identified records for eligibility. Full-text articles of potentially relevant studies were then retrieved and assessed against the eligibility criteria. Any disagreements were resolved through discussion or consultation with a third reviewer. The study selection process is detailed in the PRISMA flow diagram (Figure 1).
Data extraction was performed by two reviewers, working independently and using a standardized data extraction matrix to collect study characteristics (first author, year of publication, study design, sample size), intervention details, follow-up duration, and key clinical outcomes, followed by side-by-side cross-verification. Any coding discrepancies or numerical disagreements were resolved through structured consensus meetings, with a designated third senior reviewer (Alnofeay KA) acting as formal adjudicator. Standardized protocols were established for handling missing data, whereby corresponding authors were contacted for clarification; if data remained unreported, missing variables were documented without imputing mathematical assumptions. Baseline characteristics across study arms, including mean age, sex distribution, mechanism of injury, and displacement severity, were systematically extracted and evaluated to confirm baseline comparability between operative and nonoperative cohorts in the primary trials.
The methodological quality of the included studies was independently assessed by two reviewers, with any discrepancies resolved by consensus. The Cochrane Risk of Bias 2 (RoB 2) tool was used to evaluate RCTs, whereas the Newcastle-Ottawa Scale was employed for observational comparative studies.
Due to extensive clinical and methodological heterogeneity across the included literature, a quantitative meta-analysis was omitted in favor of a detailed qualitative synthesis. Although quantitative pooling and subgroup meta-analyses (stratified by implant type [plate vs elastic stable intramedullary nailing (ESIN), follow-up intervals (short term vs long term), and fracture classification] were initially planned during PROSPERO protocol registration, formal quantitative pooling was abandoned prior to synthesis. Preliminary heterogeneity assessments revealed extreme residual statistical heterogeneity (I2 > 85), driven by unstandardized primary trial reporting (e.g., median with interquartile ranges vs mean with standard deviations), unstratified fracture classification aggregates, and disparate functional scoring metrics [DASH, Constant-Murley, American Shoulder and Elbow Surgeons (commonly known as ASES)]. Attempting quantitative pooling under these conditions would have yielded mathematically invalid summary effect estimates. This clinical and methodological heterogeneity spanned four principal domains: (1) Fixation techniques, involving varying plate constructs vs intramedullary devices (ESIN); (2) Fracture Classification Variability, utilizing Allman, Robinson, or AO/OTA systems; (3) Outcome measurement tools (DASH, Constant, ASES); and (4) Heterogeneous follow-up intervals, ranging from early acute phases up to 24 months.
The initial literature search yielded 612 potential records. After removing duplicates and screening titles and abstracts, 50 full-text articles were assessed for eligibility. Ultimately, 15 studies met the inclusion criteria and were included in this review. These comprised nine RCTs, one CCT, three prospective cohort studies, and two retrospective cohort studies. The detailed selection process is illustrated in the PRISMA flow diagram (Figure 1).
The 15 included studies[5-9,13-22] comprised a total of 1615 patients, of whom 838 underwent operative treatment and 777 received nonoperative treatment. The operative interventions primarily consisted of open reduction and internal fixation with plates (12 studies), whereas 3 studies evaluated ESIN (also commonly referred to as ESIN) or locked intramedullary fixation. The follow-up duration across the studies ranged from 12 months to 24 months (Table 1)[5-9,13-22].
| Study | Year | Design | Sample size, n for op/non-op among (n = 1615) | Loss to follow-up | Intervention vs comparator | Key outcomes (follow-up) |
| Jubel et al[13] | 2005 | CCT | 53/53 | None reported | ESIN vs sling | Better early pain reduction and ROM with ESIN; excellent functional results (12 months) |
| Canadian Orthopaedic Trauma Society[6] | 2007 | RCT | 67/65 | Op: 5 lost; non-op: 7 lost | Plate fixation vs sling | Nonunion 2% vs 15%; better early DASH/Constant scores (12 months) |
| Smekal et al[15] | 2009 | RCT | 30/30 | Op: 2 lost; non-op: 1 lost | ESIN vs sling | 0 nonunions (Op) vs 3 (non-op); better early function with ESIN |
| Ferran et al[16] | 2010 | RCT | 17/15 | 0 lost | Locked IM nail vs plate | 100% union in both groups; no significant difference (12 months) |
| Kulshrestha et al[14] | 2011 | Prospective study | 73/68 | Op: 3 lost; non-op: 5 lost | Plate fixation vs sling | Significantly lower nonunion rate and better functional scores in operative group (18 months) |
| Mirzatolooei[21] | 2011 | RCT | 32/30 | Op: 1 lost; non-op: 2 lost | Plate/ESIN vs bandage | Nonunion 0% vs 13%; significantly better Constant scores with surgery at 12 months |
| Virtanen et al[7] | 2012 | RCT | 30/30 | Op: 2 lost non-op: 0 lost | Plate fixation vs sling | Nonunion 0% vs 24%; similar function at 12 months |
| Robinson et al[5] | 2013 | RCT | 100/100 | Op: 4 lost non-op: 6 lost | Plate fixation vs sling | Nonunion 1% vs 16%; cosmetic satisfaction better (12 months) |
| Mukherjee et al[17] | 2014 | Prospective study | 34 (Op) | 2 lost | Plate fixation | 100% union; early return to function; no major complications (single-arm series) |
| Ahrens et al[8] | 2017 | RCT | 154/147 | Op: 8 lost; non-op: 11 lost | Plate fixation vs sling | Lower nonunion; improved early function; reoperation common (12 months) |
| Bhardwaj et al[19] | 2018 | Prospective study | 36/33 | Op: 1 lost; non-op: 2 lost | Plate fixation vs sling | Faster union (15.6 weeks vs 22.8 weeks); better Constant scores at 24 months; 6% nonunion in conservative group |
| Qvist et al[9] | 2018 | RCT | 75/71 | Op: 3 lost; non-op: 4 lost | Plate fixation vs nonoperative management | Faster early recovery; higher union rate; functional outcomes comparable by 6-12 months |
| Pathak et al[18] | 2019 | RCT | 42/42 | 0 lost | Plate vs figure-of-eight | Faster union with surgery (12.4 weeks vs 14.3 weeks); better early ASES scores; no difference at 12 months |
| Ma et al[20] | 2020 | Retrospective cohort | 45/38 | 0 lost | Plate fixation vs sling | Op: 100% union; non-op: 89.5% union. Better function in Op group |
| Han et al[22] | 2024 | Retrospective cohort | 50/55 | 0 lost | Plate fixation vs nonoperative management | Union 98% (Op) vs 87% (non-op); faster union (2.4 months vs 3.7 months) and return to work with surgery |
RCTs: The methodological quality of the eight confirmed RCTs was assessed using the RoB 2 tool. The overall risk of bias was categorized as moderate to high, primarily driven by performance bias. Owing to the distinct nature of the interventions (surgical plating vs nonsurgical sling), blinding of participants and treating surgeons was not feasible in any study, resulting in a consistently high risk of bias in the domain of deviations from intended interventions. In contrast, the risk of detection bias was considered low, as the primary outcome, radiographic union, is an objective measure that was independently assessed by radiologists in high-quality trials such as those conducted by the COTS[6], Ahrens et al[8], and Qvist et al[9]. Selection bias was minimized through appropriate methods of random sequence generation and allocation concealment (Table 2)[5-9,15,16,18,21].
| Study | Randomization process | Deviations from intended interventions | Missing outcome data | Measurement of outcome | Selection of reported result | Overall risk of bias |
| COTS | Low | High | Low | Low | Low | High |
| Smekal et al[[15] | Low | High | Low | Low | Low | High |
| Ferran et al[16] | Low | High | Low | Low | Low | High |
| Mirzatolooei[21] | Low | High | Low | Low | Low | High |
| Virtanen et al[7] | Low | High | Low | Low | Low | High |
| Ahrens et al[8] | Low | High | Low | Low | Low | High |
| Qvist et al[9] | Low | High | Low | Low | Low | High |
| Pathak et al[18] | Low | High | Low | Low | Low | High |
| Robinson et al[5] | Low | High | Low | Low | Low | High |
Observational and comparative studies: The methodological quality of the six observational studies, including prospective cohorts, retrospective series, and CCTs, was evaluated using the Newcastle-Ottawa Scale. The quality scores ranged from 5 stars to 8 stars (maximum score: 9). Studies by Kulshrestha et al[14] and Han et al[22] demonstrated high quality in the Selection domain, owing to the use of clearly defined cohorts of adult patients with displaced midshaft clavicle fractures. The primary limitation across these studies was the Comparability domain, as retrospective studies, such as that by Ma et al[20], often relied on surgeon or patient preference for treatment allocation rather than randomization, introducing selection bias. The study by Mukherjee et al[17] received a lower score as it was a single-arm prospective study lacking a control group for direct comparison (Table 3)[13,14,17,19,20,22].
| Study | Design | Selection (Max 4 stars) | Comparability (Max 2 stars) | Outcome (Max 3 stars) | Total score (Max 9 stars) |
| Jubel et al[13] | Controlled clinical trial | ★★★★ | ★ | ★★ | 7 |
| Kulshrestha et al[14] | Prospective cohort study | ★★★★ | ★ | ★★★ | 8 |
| Mukherjee et al[17] | Single-arm prospective study | ★★★ | - | ★★ | 5 |
| Bhardwaj et al[19] | Prospective cohort study | ★★★★ | ★ | ★★ | 7 |
| Ma et al[20] | Retrospective cohort study | ★★★ | ★ | ★★ | 6 |
| Han et al[22] | Retrospective cohort study | ★★★★ | ★ | ★★ | 7 |
Radiographic outcomes: Union rates were consistently higher in the operative group across all included studies. The rate of nonunion in patients treated with operative fixation was consistently low, typically ranging from 0% to 2%. In contrast, patients managed nonoperatively exhibited significantly higher nonunion rates. For example, Virtanen et al[7] reported a nonunion rate of 24% in the nonoperative group, while the COTS trial[6] reported a rate of 15%. Recent retrospective studies by Han et al[22] and Ma et al corroborated these findings, with reported nonoperative union rates of 87% and 89.5%, respectively, compared with nearly 100% in the operative groups.
Time to fracture union was also significantly shorter in the operative group. Bhardwaj et al[19] reported a mean time to union of 15.6 weeks in the operative group vs 22.8 weeks in the nonoperative group. Similarly, Pathak et al[18] reported faster union with plate fixation (12.4 weeks) than with figure-of-eight bandaging (14.3 weeks). Also, Han et al[22] reported a shorter mean union time of 2.4 months in the operative group compared with 3.7 months in the nonoperative group.
Functional outcomes: Early functional recovery was consistently superior in the operative group. Multiple RCTs, includ
However, these differences in functional outcomes diminished over time. By 6 months to 12 months of follow-up, several high-quality RCTs, including those by Virtanen et al[7], Qvist et al[9], and Pathak et al, reported no statistically significant differences in functional scores between the operative and nonoperative groups. An exception was the study by Kulshrestha et al, which demonstrated persistently superior functional outcomes in the operative group at 18 months.
Qualitative comparison by fixation subtype (plate osteosynthesis vs intramedullary devices): Open reduction and internal plate fixation (n = 12 studies)[5,6] provided absolute rigid stability, permitting immediate postoperative range-of-motion exercises. Plate osteosynthesis demonstrated consistent radiographic union rates (98%-100%)[5,6]; however, plating was associated with higher incisional morbidity and symptomatic hardware prominence, driving elective implant removal rates up to 27%[6]. In contrast, ESIN and locked intramedullary devices (n = 3 studies)[13,14,16] utilized minimally invasive skin incisions, resulting in superior immediate cosmetic satisfaction and reduced operative time. While intramedullary fixation achieved high union rates (96%-100%)[13,15], it also exhibited technique-specific minor complications, primarily localized skin irritation at the entry site and telescoping/medial nail prominence.
Complications: The profile of adverse events differed significantly between treatment strategies when stratified by severity.
Minor complications (low impact/self-limiting): In the operative group, minor adverse events were common, dominated by local hardware prominence, mild incisional discomfort, and transient hypoesthesia in the supraclavicular nerve distribution[6,7]. These minor events were largely self-limiting and did not impair long-term upper extremity function[6,7].
Major complications (high impact/reoperation): Major surgical complications were rare in the operative cohort, but included deep surgical site infection, implant breakage, and nonunion (0%-5%)[5,6], as well as symptomatic malunion. Secondary surgical interventions in the surgical group were overwhelmingly elective procedures for hardware removal due to patient preference or localized irritation rather than structural fixation failure[6,9]. Conversely, adverse outcomes in the nonoperative group were overwhelmingly major and clinically high-impact, characterized by significantly higher nonunion rates (6%-24%)[5,6,8] and symptomatic malunion with shoulder girdle shortening, frequently necessitating secondary reconstructive osteotomy and delaying plate fixation[5,6].
The stark contrast in nonunion rates between treatment cohorts (under 5% operative vs 6%-24% nonoperative) highlights the fundamental biomechanical vulnerabilities of conservative management in the face of complete displacement. Anatomically, the clavicle features a unique dual S-shaped contour that acts as the sole bony strut connecting the axial skeleton to the upper extremity shoulder girdle. When a high-energy traumatic force induces a completely displaced midshaft fracture, this structural integrity collapses, leaving the bone fragments completely at the mercy of opposing muscle forces.
Specifically, the proximal fracture fragment is drawn superiorly and posteriorly by the unopposed vector force of the sternocleidomastoid muscle. Concurrently, the distal fragment is pulled inferiorly and medially, and rotated forward by the heavy gravitational weight of the arm combined with the strong adduction traction of the deltoid and pectoralis major muscles. This results in severe shortening, bayonet apposition, and soft tissue interposition.
For conservatively managed patients, sustaining a satisfactory closed reduction is notoriously unpredictable. While our included studies primarily evaluated completely displaced fractures as a single cohort, the broader orthopedic literature establishes that comminuted fracture subtypes experience dramatically worse healing dynamics under conservative care. Comminution destroys the intrinsic cortical load-sharing capacity of the bone; without absolute stability, ongoing micro-motion driven by the shoulder girdle musculature inevitably leads to late loss of reduction, widening of the fracture gap, and high rates of symptomatic malunion or nonunion.
Conversely, operative stabilization via open reduction and internal fixation neutralizes these powerful deforming muscular forces. Rigid internal plate fixation restores the clavicle’s anatomical length and its natural S-shaped orientation, ensuring immediate mechanical stability. This mechanical advantage allows for safe, immediate early mobilization, bypassing the prolonged immobilization period that contributes to early stiffness and functional delay in the nonoperative cohort.
While the primary focus of this systematic review remains the overarching comparison between operative fixation and nonoperative management, our qualitative sub-analysis highlights notable trade-offs between surgical fixation constructs[5,6,13,15]. Plate osteosynthesis offers immediate rigid stability and superior fracture reduction at the expense of larger surgical exposures and higher rates of soft-tissue/hardware prominence[5,6,10]. Conversely, ESIN provides a minimally invasive, cosmetically favorable alternative with equivalent union rates, though its utility is primarily restricted to noncomminuted, simple midshaft patterns[13,15,16]. Ultimately, while nonoperative management avoids all implant-related trade-offs, surgical intervention-regardless of construct subtype-consistently provides superior prevention of nonunion and symptomatic malunion in displaced fractures[5,6,8].
These results validate the early recovery benefits highlighted by the landmark COTS trial[6]. Surgery provides imme
The choice of treatment involves a trade-off between the risk of nonunion/malunion and surgical adverse events[5,6]. When evaluating surgical risk, it is essential to distinguish minor, self-limiting implant symptoms from major structural failures. While the gross surgical complication rate reaches up to 27% in the plate fixation series[6], the vast majority of those cases involve minor hardware irritation and soft-tissue prominence that require no immediate emergency intervention[6,10]. Secondary surgeries in the operative cohort are primarily elective procedures for implant removal following solid bone union[6]. In contrast, complications arising from nonoperative care are dominated by high-impact, major adverse events, specifically composed of nonunion rates of up to 24%[5,6,8] and symptomatic malunion leading to mechanical fatigue and loss of shoulder girdle endurance[1,5]. Differentiating minor hardware symptoms from major functional nonunions provides a far more accurate clinical risk-benefit profile for patient counseling[11,12].
Our findings support the 2022 guidelines by the American Academy of Orthopaedic Surgeons, which advocate for shared decision-making in the management of displaced midshaft clavicle fractures. Operative fixation is strongly supported for patients requiring expedited return to activity or those at high risk of nonunion, such as individuals with significant fracture displacement. Conversely, for patients willing to accept a longer recovery period to avoid the risks associated with surgery, nonoperative management remains a viable option, provided they are monitored closely for signs of delayed union.
The strengths of this systematic review include adherence to the PRISMA 2009 guidelines, a focus on comparative studies involving adult patients with displaced midshaft clavicle fractures, and explicit risk-of-bias assessment. Furthermore, our qualitative synthesis is inherently constrained by structural gaps within the primary source literature. First, the majority of global clinical trials have aggregated completely displaced fractures under a broad umbrella, omitting granular stratification of clinical outcomes by specific fracture subtypes (e.g., Robinson 2B1 vs 2B2) or by post-treatment reduction quality. Second, while specific attrition rates were not tabulated explicitly due to heterogeneous reporting across retrospective subsets, a meticulous tracking of the literature revealed only minor attrition rates across the included cohorts; however, because the primary high-quality RCTs rigidly adhered to intention-to-treat analysis models, the risk of structural attrition bias affecting our long-term functional conclusions remains low.
However, several limitations should also be acknowledged. First, our literature search was restricted to peer-reviewed, English-language publications, and unindexed grey literature (such as conference proceedings or unpublished trial registry data) was not retrieved, introducing potential publication and language bias that may selectively favor surgical fixation by under-representing unpublished neutral or negative nonoperative outcomes. Second, substantial heterogeneity existed among the included studies with respect to surgical techniques, particularly the use of plate fixation vs intramedullary devices, as well as in outcome measures and reporting methods. Third, some studies provided incomplete reporting of specific complication domains, which may have limited direct comparisons across treatment groups. Finally, a quantitative meta-analysis was not performed because of the clinical and methodological heterogeneity of the available evidence. However, the consistency of the findings across multiple high-quality RCTs supports the overall conclusions.
Operative fixation of displaced midshaft clavicle fractures is associated with higher union rates and earlier functional recovery compared with nonoperative management. However, long-term functional outcomes are generally comparable between treatment strategies, and operative intervention carries a risk of implant-related complications and secondary procedures. Therefore, treatment decisions should be individualized, balancing the clear mechanical advantages of surgery against the patient’s specific lifestyle needs and tolerance for surgical risk.
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