Orthopedics

Feature Article 

Operative Versus Nonoperative Treatment for Complex Proximal Humeral Fractures: A Meta-analysis of Randomized Controlled Trials

Zhiwei Jia, MD; Wei Li, MD; Yingyi Qin, PhD; Haifeng Li, MD; Deli Wang, MD; Chao Zhang, MD; Qing He, MD; Dike Ruan, MD, PhD

Abstract

Whether operative treatment for complex proximal humeral fractures has a greater benefit over nonoperative treatment is uncertain. The authors conducted a meta-analysis to include all randomized controlled trials (RCTs) to determine the advantages and disadvantages of operative vs nonoperative treatment. Multiple databases, online registries of RCTs, and proceedings from major meetings were systematically searched up to November 2012. Randomized controlled trials comparing operative and non-operative treatment for 3- and 4-part proximal humeral fractures were included. Two authors independently assessed methodological quality and extracted data. Seven articles with a total of 286 patients met inclusion criteria. No significant differences were found between operative and nonoperative treatment regarding Constant score, the Disabilities of the Arm, Shoulder and Hand score, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, 15 Dimensions, and complications. Health-related quality of life according to the EuroQol-5D score in operative treatment showed statistically, but not clinically, significant improvement compared with nonoperative treatment. Operative treatment could significantly increase the incidence of additional surgery at 12- and 24-month follow-up compared with nonoperative treatment. However, sensitivity analysis showed a higher additional surgery rate at 12-month follow-up remained unstable. On the basis of current evidence, both operative and nonoperative treatment can achieve a similar treatment effect on complex proximal humeral fractures, but operative treatment may increase the occurrence of additional surgery. However, due to some limitations, the result of this meta-analysis should be cautiously interpreted, and further studies are needed.

The authors are from the Department of Orthopaedics (ZJ, WL, HL, DW, CZ, QH, DR), Navy General Hospital, Beijing; and the Department of Health Statistics (YQ), Second Military Medical University, Shanghai, China.

Drs Jia, Li, and Qin contributed equally to this work and should be considered as equal first authors

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Dike Ruan, MD, PhD, Department of Orthopaedics, Navy General Hospital, No 6, Fucheng Rd, Beijing 100048, China ( ruandikengh@163.com).

Received: June 23, 2013
Accepted: November 25, 2013

Abstract

Whether operative treatment for complex proximal humeral fractures has a greater benefit over nonoperative treatment is uncertain. The authors conducted a meta-analysis to include all randomized controlled trials (RCTs) to determine the advantages and disadvantages of operative vs nonoperative treatment. Multiple databases, online registries of RCTs, and proceedings from major meetings were systematically searched up to November 2012. Randomized controlled trials comparing operative and non-operative treatment for 3- and 4-part proximal humeral fractures were included. Two authors independently assessed methodological quality and extracted data. Seven articles with a total of 286 patients met inclusion criteria. No significant differences were found between operative and nonoperative treatment regarding Constant score, the Disabilities of the Arm, Shoulder and Hand score, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, 15 Dimensions, and complications. Health-related quality of life according to the EuroQol-5D score in operative treatment showed statistically, but not clinically, significant improvement compared with nonoperative treatment. Operative treatment could significantly increase the incidence of additional surgery at 12- and 24-month follow-up compared with nonoperative treatment. However, sensitivity analysis showed a higher additional surgery rate at 12-month follow-up remained unstable. On the basis of current evidence, both operative and nonoperative treatment can achieve a similar treatment effect on complex proximal humeral fractures, but operative treatment may increase the occurrence of additional surgery. However, due to some limitations, the result of this meta-analysis should be cautiously interpreted, and further studies are needed.

The authors are from the Department of Orthopaedics (ZJ, WL, HL, DW, CZ, QH, DR), Navy General Hospital, Beijing; and the Department of Health Statistics (YQ), Second Military Medical University, Shanghai, China.

Drs Jia, Li, and Qin contributed equally to this work and should be considered as equal first authors

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Dike Ruan, MD, PhD, Department of Orthopaedics, Navy General Hospital, No 6, Fucheng Rd, Beijing 100048, China ( ruandikengh@163.com).

Received: June 23, 2013
Accepted: November 25, 2013

Proximal humeral fractures are common fractures that account for approximately 4% to 5% of all fractures.1 The incidence of these fractures rapidly increases as the population ages and is particularly pronounced in women.2,3 Proximal humeral fractures are the third most common fractures after hip and distal radius fractures.3,4 Most of these fractures are stable and minimally displaced or nondisplaced osteoporotic fractures. Many patients could regain shoulder function with nonoperative treatment5 and only approximately 20% of patients are treated operatively.6

Displaced 3- and 4-part fractures are among the most challenging proximal humeral fractures.7 These complex fractures may compromise blood supply and cause more complications.6 Both operative and nonoperative methods are used to treat these fractures. Due to advancements in surgical techniques and expectations for better shoulder function, operative treatment has become increasingly popular for these injuries. Several surgical methods have also been advocated, including Kirschner wire fixation, screw fixation, plate fixation, and prosthetic replacement.5 However, the optimal treatment for these fractures remains controversial.5,8,9 Although numerous studies have reported on operative and nonoperative treatment, few randomized controlled trials (RCTs) have been conducted to compare them. For this, previous systematic reviews on the treatment of proximal humeral fractures concluded that insufficient evidence exists supporting the choice of treatment.8,9 The need remains for strong evidence based on the latest high-quality RCTs to analyze the optimal treatment.

In addition, no systematic review has interpreted the results with respect to clinical significance on proximal humeral fractures. The aim of the current meta-analysis was to determine the advantages and disadvantages of operative versus nonoperative treatment for complex proximal humeral fractures.

Materials and Methods

Search Strategy and Selection Criteria

This review was conducted and reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement issued in 2009.10 The authors searched all publications from January 1980 to November 2012 using electronic databases, including PubMed, Embase, CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews, Cochrane Bone, Joint and Muscle Trauma Group Specialized Register, China National Knowledge Infrastructure (CNKI), Chinese BioMedical Literature Database (CBM), and Chinese Medical Current Content (CMCC). They also searched for unpublished trials and those in progress using clinical trials repositories, including the National Institute of Health, the National Research Register, Current Controlled Trials, and Trials Central. The search was supplemented by archives of abstracts from annual meetings, including the Orthopaedic Trauma Association, the American Academy of Orthopaedic Surgeons, and the Canadian Orthopaedic Association.

The search strategy first used Mesh terms (“Humerus” [Mesh] OR “Humeral Fractures” [Mesh]) and type of clinical trial (Randomized controlled trial and Clinical trial) and then a secondary free search was performed using multiple keywords (humer* and fractur* and random*) to ensure inclusion all possible studies. Two authors (Z.J., Y.Q.) conducted the search independently in duplicate, with no restriction on language or publication status. The abstract of any study that was potentially relevant to the topic was reviewed. The full text was obtained if inadequate information was acquired from the abstract. Disagreements were resolved by discussion, and a third reviewer (W.L.) was consulted for the final decision when necessary. Relevant reviews regarding proximal humeral fractures were examined for potential studies.

The eligible articles had to meet the following inclusion criteria: (1) patients 18 years or older with 3- and 4-part fractures of the proximal humerus; (2) operative vs nonoperative treatment; (3) primary outcome measures were shoulder and arm outcome scores and secondary outcome measures were complications and additional surgery; and (4) published or unpublished, prospective and RCTs. This review excluded studies focused on the treatment of 1- and 2-part fractures of proximal humerus, skeletally immature individuals, delayed union, nonunion, or pathological fractures.

The primary outcome measures included Constant score (CS),11 the Disabilities of the Arm, Shoulder and Hand (DASH),12 the American Shoulder and Elbow Surgeons (ASES),13 the Simple Shoulder Test (SST),14 and health-related quality of life (HRQoL) scores according to the EuroQol-5D (EQ-5D)15 and 15 Dimensions (15D).16 Secondary outcome measures included complications and additional surgery. Major complications were related to operative or nonoperative treatment (eg, infection, nonunion, symptomatic malunion, screw penetration, tuberosity redisplacement). The definition of additional surgery excluded the removal of hardware after fracture healing and closed reduction of prosthesis dislocation.

Data Extraction and Quality Assessment

Extracted information included population demographics, year of publication, fracture type, number of patients, trial duration, operative type, outcome scores, complications, and additional surgery. Authors were contacted if information could not be obtained from the original literature. For all continuous outcomes, means and standard deviations were extracted for analysis. If means and confidence intervals (CIs) were reported instead, standard deviations were calculated from these values.

Two reviewers (Z.J., W.L.) independently assessed the methodological quality of each included study with use of the Jadad score.17 The score for each article could range from 0 (lowest quality) to 5 (highest quality). Scores of 3 to 5 denoted good to excellent quality and 0 to 2 denoted poor to low quality. Disagreement was resolved by means of discussion, with arbitration by a third reviewer (Y.Q.) when differences of opinion remained.

Statistical Analysis

The primary analysis compared outcomes between operative and nonoperative treatment from all included RCTs. The value of minimal clinically important difference (MCID) was selected to evaluate whether the significant differences of outcome scores were of practical importance.18–20 Subgroup analysis was performed according to operative types and follow-ups. In addition, sensitivity analysis was performed by excluding low Jadad score studies (<3 points).

In each study, the mean differences and 95% CIs were calculated for continuous outcomes and risk ratios (RRs) and 95% CIs were calculated for dichotomous outcomes. A random effects model was used to ensure that these studies represented a random sample of all potentially available studies.21 Heterogeneity between studies was tested with use of both the chi-square test and the I-squared (I2) test.22 Statistical heterogeneity was considered significant when the P value was less than .10 for the chi-square test or I2 test was greater than 50%. All reported P values were 2-sided, and P values less than .05 were regarded as statistically significant. Statistical analyses were performed using STATA version 11.0 software (Stata Corporation, Lakeway, Texas).

Results

Literature Search

Figure 1 illustrates the study flow. A total of 6 studies included in 7 articles23–29 met inclusion criteria and 5 studies30–34 were excluded because they were ongoing and no data were available. In total, 286 patients from 6 studies were included.23–29 A total of 143 patients were treated operatively, and 143 were treated nonoperatively. All studies were RCTs that enrolled patients with complex proximal humeral fractures and published in full articles. Two studies23,27 were based on the same randomized trial and reported different outcome types. Patients in the included studies were predominately older (mean age range, 65.6 to 79.9 years) and female (86%). Other detailed information from each study was listed in Table 1.

Flow diagram of the studies search and selection process.

Figure 1:

Flow diagram of the studies search and selection process.

General Information of Included Studies

Table 1:

General Information of Included Studies

Outcome Scores

Six studies23–28 evaluated the functional outcome scores (Table 2 and Figure 2). Outcome scores included the CS, DASH, ASES, SST, and 15D and were reported in different studies. Analysis showed no significant difference in each outcome score between operative and nonoperative treatment at all available follow-ups (Table 2). EQ-5D scores were reported in 2 studies.25,26 No significant difference was found between operative and nonoperative treatment at 12-month follow-up (mean differences, 0.08; 95% CI, −0.02 to 0.17; P=.10) but the treatment did have statistically significant differences at 4-month follow-up (mean differences, 0.10; 95% CI, 0.00 to 0.20; P=.04) and 24-month follow-up (mean differences, 0.15; 95% CI, 0.05 to 0.25; P=.004). Further analysis with MCID of EQ-5D on these significant differences showed that the 95% CIs of these overall effects crossed the MCID threshold of 0.074 (Figure 2).18

Outcome Scores After Operative and Nonoperative Treatment

Table 2:

Outcome Scores After Operative and Nonoperative Treatment

EQ-5D scores after operative and nonoperative treatment. Abbreviations: CI, confidence interval; MCID, minimally clinically important difference.

Figure 2:

EQ-5D scores after operative and nonoperative treatment. Abbreviations: CI, confidence interval; MCID, minimally clinically important difference.

Complications

Complications were available in 6 studies23–26,28,29 for 286 patients. The pooled results showed that no statistically significant difference was found between operative and nonoperative treatment, although operative treatment was associated with a higher risk of complications (RR, 1.41; 95% CI, 0.96 to 2.07; P=.08). Subgroup analysis also showed no significant difference in the comparison of either internal fixation (RR, 1.48; 95% CI, 0.81 to 2.71; P=.20) or hemiarthroplasty (RR, 1.50; 95% CI, 0.72 to 3.13; P=.28) with nonoperative treatment, although a similar increased risk was observed (Figure 3).

Complications after operative and nonoperative treatment. Abbreviation: CI, confidence interval.

Figure 3:

Complications after operative and nonoperative treatment. Abbreviation: CI, confidence interval.

Additional Surgery

Additional surgery was reported in 6 studies23–26,28,29 for 286 patients at 12 months follow-up and in 4 studies25,26,28,29 with 186 patients at 24 months. Pooled analysis showed that operative treatment was associated with a significant higher incidence of additional surgery compared with nonoperative treatment at 12-month follow-up (RR, 3.19; 95% CI, 1.06 to 9.62; P=.04) and 24-month follow-up (RR, 4.54; 95% CI, 1.32 to 15.56; P=.02). Subgroup analysis showed that both internal fixation and hemiarthroplasty were associated with higher risk of additional surgery compared with nonoperative treatment at 12- and 24-month follow-up, but only internal fixation at 24-month follow-up was associated with a statistically significant higher risk compared with nonoperative treatment (RR, 6.40; 95% CI, 1.18 to 34.62; P=.03) (Figure 4).

Additional surgery after operative and nonoperative treatment at 12-month (A) and 24-month (B) follow-up. Abbreviation: CI, confidence interval.

Figure 4:

Additional surgery after operative and nonoperative treatment at 12-month (A) and 24-month (B) follow-up. Abbreviation: CI, confidence interval.

Sensitivity Analysis

Sensitivity analysis was performed by exclude low-quality studies (Jadad score <3 points). Based on the list of study characteristics, the current authors conducted a secondary sensitivity analysis excluding the only low-quality study with a Jadad score of 2.29 The sensitivity analysis showed that the incidence of complications and additional surgery at 24-month follow-up were similar to those before exclusion of the low-quality study (Table 3). This indicated that the low-scoring study had no bias impact on the previous meta-analysis results regarding complication rate and additional surgery rate at 24-month follow-up. However, the exclusion of the low-quality study did lower the incidence of additional surgery with operative treatment at 12-month follow-up, which had an obvious bias effect on the previous meta-analysis result regarding additional surgery at 12-month follow-up (Table 3).

Results of Sensitivity Analysis

Table 3:

Results of Sensitivity Analysis

Discussion

This is the first systematic review on proximal humeral fractures to incorporate MCID in interpreting findings. This approach focuses on clinically important difference as opposed to statistically important difference. The study populations of all included studies are predominantly older and female. According to the best available evidence, this meta-analysis suggests that (1) no significant differences exist between operative and nonoperative treatment with regard to shoulder and arm functionality and complications for complex proximal humeral fractures; (2) operative treatment is associated with a statistically but not clinically significant improvement in HRQoL compared with nonoperative treatment; and (3) operative treatment could increase the incidence of additional surgery in comparison with nonoperative treatment.

Shoulder and arm functionality is one of the most critical outcomes when considering the use of operative treatment over nonoperative treatment. Various measures have been developed to assess shoulder and arm disability. The measures can contain either self-reported or performance-based assessments or a combination of both. Among those measures, the CS is unique and widely used to evaluate functional recovery of the shoulder after surgical interventions because it has both self-report and performance-based components. The DASH is a region-specific outcome score developed to measure physical disability and symptoms of the upper extremities in patients with upper extremity disorders. The ASES is a patient self-assessment form on measure functional limitations and shoulder pain. The SST is a shoulder-specific outcome score and is simple and easy to complete. However, based on these outcome scores, the authors’ analysis shows that operative treatment has no significant benefit on shoulder and arm functional recovery compared with nonoperative treatment at all available follow-ups. Anatomic reduction and stable reduction may be the major factors affecting functional outcomes of the shoulder postoperatively.5,35–38 For internal fixation, large metaphyseal defects after the typical mechanism of impaction complicate the anatomic reduction and fixation. The metaphyseal void remains after the reduction, making retention of the anatomic reduction difficult.38 Regarding hemiarthroplasty, tuberosity malunion and nonunion significantly correlate with poor outcome, causing limited motion and subacromial impingement. In addition, many patients are also unable to comply with an aggressive rehabilitation program, and this may result in symptomatic periarticular adhesions.5 Therefore, accurate decision making, careful surgical technique, and patient compliance with the rehabilitation program may be critical factors in achieving good outcomes.

All available mean difference of EQ-5D scores between operative and nonoperative treatment are higher than the MCID of 0.074 at different times points,18 among which statistically significant differences were found at 4- and 12-month follow-up, but the 95% CIs of these results cross the MCID value of the EQ-5D (Figure 2), which indicate that the range of plausible difference between treatments are unlikely to have a clinical difference. The findings of the 15D also show that operative treatment has no significant benefit over nonoperative treatment at different follow-ups. In addition, the only available cost-effectiveness study could not support the hypothesis that operative treatment entails better outcome or lower costs.27 Nevertheless, HRQoL in older patients should be substantially influenced by proximal humeral fractures, regardless of operative or nonoperative treatment.25,26 All of these outcomes indicate that neither operative nor nonoperative treatment can achieve ideal clinical results, and operative treatment might fail to show a clinical benefit compared with nonoperative treatment; future studies are needed to improve the treatment effect.

The overall complication rate is higher in the operative group than in the non-operative group (40.6% vs 27.3%, respectively), but it is not statistically significant (P=.08). Some of these complications (eg, nonunion) may occur with both operative and nonoperative methods.5 Many complications in the operative group (eg, screw penetration, tuberosity redisplacement) might result in an unsatisfactory outcome and require additional interventions.25,26 Modern technology provides more secure methods for complex proximal humeral fractures,36,39–41 theoretically reducing the occurrence of complications. However, the authors’ analysis shows that neither internal fixation nor hemiarthroplasty has significant benefit over nonoperative treatment with regard to complications (Figure 3). This higher incidence of complications may be associated with surgical expertise. Many complications could be minimized by improved operative techniques.36,41,42

The additional surgery rate was 7.7% at 12-month follow-up and 15.1% at 24-month follow-up in operative treatment, which is significantly higher than that for nonoperative treatment (1.4% and 2.2%, respectively) (Figure 4). A secondary sensitivity analysis shows that a low-quality study29 had a bias impact on the pooled estimate of additional surgery rate at 12-month follow-up (Table 3). It should be noted that additional surgery is an overall treatment effect, and the indications are uncertain. Some complications, such as implant failure, usually necessitate additional surgery, but some complications, such as osteoarthritis, remain inconclusive, which might result in potential bias with the final result. Therefore, the finding of additional surgery at 12-month follow-up should be interpreted conservatively. Adding RCTs with larger sample sizes might help give a stable estimate of additional surgery risk. In addition, at 24-month follow-up additional surgery for internal fixation is associated with a significantly higher risk than nonoperative treatment (Figure 4). It may be attributed to the high incidence of complications (45.3%) for internal fixation (Figure 3). Furthermore, it may be associated with the fact that many additional surgeries are performed during the second year,24,25 which suggested that 24-month follow-up is recommended.

Due to a lack of high-quality studies, previous systematic reviews on this topic came to a similar conclusion—that the quality of evidence did not support valid decision making between operative and nonoperative treatment.8,9 In the current meta-analysis, the authors tried to conduct a comprehensive literature search to include all available evidence, to complete data extraction and methodological assessments in duplicate, and to make conclusions based only on high-quality RCTs. In addition, they incorporated MCID to identify clinical differences from statistically significant results.

However, this study has some limitations common to all meta-analysis in addition to other specific limitations. Although the authors’ best efforts were made in using multiple search strategies and available databases to include all possible studies, publication bias may be unavoidable. The included studies have some limitations, including small sample sizes, incomplete reporting of treatment allocation concealment, and no possibility of blinding patients and surgeons. In addition, the variety of outcome measures limits the authors’ ability to combine outcomes and make definitive conclusions, and might even result in a decrease in their ability to identify a true difference wherein one actually exists. For example, the authors could analyze complications from all included studies, but not for the DASH and EQ-5D because only 2 of the included studies reported those measures.

Conclusion

In this meta-analysis of RCTs, the results suggest that operative treatment for complex proximal humeral fractures has no significant advantage in improving shoulder and arm function and quality of life and reducing complications when compared with nonoperative treatment. However, a higher incidence of additional surgery was observed with operative treatment. Based on the results of this meta-analysis, both operative and nonoperative treatment can achieve a similar treatment effect on complex proximal humeral fractures, but operative treatment may increase the occurrence of additional surgery. The limitations of the available studies and this meta-analysis indicate the planning and performance of sufficiently sized, methodologically sound studies with clinically relevant outcomes. Although this meta-analysis provides the best estimate of operative versus nonoperative treatment for complex proximal humeral fractures, the results should be interpreted with caution until confirmed by large, definitive RCTs.

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General Information of Included Studies

Study Cases (O/N), No. Sex (M/F), No. Mean age (O/N), y Operative Type Minimal Follow-up, mo Jadad Score
Fjalestad et al23 25/25 6/44 72.2/73.1 IF 12 3
Boons et al24 25/25 3/47 76.4/79.9 HA 12 3
Olerud et al25 30/29 10/48 72.9/74.9 IF 24 3
Olerud et al26 27/28 8/47 75.8/77.5 HA 24 3
Fjalestad et al27 25/25 6/44 72.2/73.1 IF 12 3
Zyto et al28 20/20 5/35 73.0/75.0 IF 50 3
Stableforth29 16/16 7/25 65.6/70.1 HA 18 2

Outcome Scores After Operative and Nonoperative Treatment

Outcome Score MD (95% CI) P Heterogeneity
Chi-square I2, % P
CS
  12 months23–26 2.59 (−2.21 to 7.39) .29 0.56 0 .90
  24 months25,26 0.48 (−7.26 to 8.22) .90 0.24 0 .62
  50 months28 −5.00 (−17.52 to 7.52) .43
DASH
  12 months25,26 −4.51 (−13.50 to 4.48) .33 0.11 0 .74
  24 months25,26 −7.43 (−16.26 to 1.41) .10 0.04 0 .84
ASES
  6 months23 0.10 (−3.66 to 3.86) .96
  12 months23 −0.70 (−4.52 to 3.12) .72
SST
  3 months24 −7.00 (−17.81 to 3.81) .20
  12 months24 2.00 (−59.55 to 63.55) .95
15D
  3 months27 −0.00 (−0.04 to 0.04) .88
  6 months27 0.02 (−0.03 to 0.07) .44
  12 months27 0.02 (−0.03 to 0.08) .42

Results of Sensitivity Analysis

Outcome All Eligible RCTs Included
Only RCTs With High Scores Included
Cases, No. I2, % RR (95% CI) P Cases, No. I2, % RR (95% CI) P
Complications 286 23 1.41 (0.96 to 2.07) .08 254 30 1.39 (0.94 to 2.07) .10
Additional surgery
  12 months 286 0 3.19 (1.06 to 9.62) .04 254 0 3.22 (0.99 to 10.47) .05
  24 months 186 0 4.54 (1.32 to 15.56) .02 154 0 4.90 (1.28, 18.70) .02

10.3928/01477447-20140528-54

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