Orthopedics

Feature Article Supplemental Data

Risk Factors for Hardware-Related Complications After Olecranon Fracture Fixation

George Bugarinovic, BS; Kelly H. McFarlane, BS; Kyra A. Benavent, BS; Stein J. Janssen, MD, PhD; Philip E. Blazar, MD; Brandon E. Earp, MD

Abstract

The aim of this study was to evaluate risk factors for symptomatic hardware and removal of hardware (ROH) after olecranon open reduction and internal fixation (ORIF) and to assess differences between olecranon locking plate and screws (P&S) or tension band (TB) wire cohorts. The medical records of 331 patients with olecranon fractures treated at two academic level I trauma centers with ORIF from 2012 to 2016 were reviewed. A total of 189 patients were included in the study. Complications, ROH, and subsequent surgery were assessed and compared between cohorts. There were 124 cases in the P&S cohort and 65 in the TB cohort. The overall reoperation rate was 31.2% (59 of 189). The overall incidence of ROH for all cases was 29.1% (55 of 189). Patients who required ROH or developed symptomatic hardware were significantly younger than those who did not (P&S, P<.003; TB, P<.004). Age and body mass index (BMI) were associated with ROH plus symptomatic hardware after P&S. Age (but not BMI) was associated with ROH/symptomatic hardware after TB. Measured hardware prominence was not associated with ROH or ROH plus symptomatic hardware for either the P&S or the TB cohort. Risk factors including patient age and BMI were found to be significantly associated with hardware-related complications. [Orthopedics. 2020;43(3):141–146.]

Abstract

The aim of this study was to evaluate risk factors for symptomatic hardware and removal of hardware (ROH) after olecranon open reduction and internal fixation (ORIF) and to assess differences between olecranon locking plate and screws (P&S) or tension band (TB) wire cohorts. The medical records of 331 patients with olecranon fractures treated at two academic level I trauma centers with ORIF from 2012 to 2016 were reviewed. A total of 189 patients were included in the study. Complications, ROH, and subsequent surgery were assessed and compared between cohorts. There were 124 cases in the P&S cohort and 65 in the TB cohort. The overall reoperation rate was 31.2% (59 of 189). The overall incidence of ROH for all cases was 29.1% (55 of 189). Patients who required ROH or developed symptomatic hardware were significantly younger than those who did not (P&S, P<.003; TB, P<.004). Age and body mass index (BMI) were associated with ROH plus symptomatic hardware after P&S. Age (but not BMI) was associated with ROH/symptomatic hardware after TB. Measured hardware prominence was not associated with ROH or ROH plus symptomatic hardware for either the P&S or the TB cohort. Risk factors including patient age and BMI were found to be significantly associated with hardware-related complications. [Orthopedics. 2020;43(3):141–146.]

Fractures of the olecranon account for 10% of all adult upper limb fractures and most often occur after a fall from standing height in middle-aged or elderly patients.1,2 Most olecranon fractures are simple, displaced, non-comminuted fractures,3 and surgical intervention with open reduction and internal fixation (ORIF) is the treatment used for most of these injuries.4–7

A variety of techniques and types of hardware are used in the surgical treatment of olecranon fractures. Most common are ORIF with a tension band (TB) construct or ORIF with a locking plate and screws (P&S). Locking plate fixation has become increasingly popular in recent years, having good functional outcomes.8–10 However, postoperative complications, particularly those requiring removal of hardware (ROH), are reported in 15% to 56% of P&S patients and 20% to 92% of TB patients.11–15

The aim of this study was to evaluate factors associated with postoperative complications and ROH. The null hypothesis was that hardware prominence; patient age, sex, and body mass index (BMI); and type of implant would not be associated with ROH.

Materials and Methods

This retrospective cohort study of patients with olecranon fractures treated with ORIF at two level I academic trauma centers from 2012 to 2016 received institutional review board approval. Three hundred thirty-one patients were identified through billing records for Current Procedural Terminology code 24685 (open treatment of ulnar fracture proximal end, with or without internal or external fixation). These patients were treated by 11 orthopedic surgeons within the study period. Sixty patients were excluded for multiple reasons: surgical treatment other than ORIF with an olecranon plate or TB (eg, radial head implants, screws plus radial head implants, or screws plus K-wires; n=38), index surgery being a revision ORIF with primary revision surgery (n=12), olecranon osteotomy (n=3), or age younger than 18 years (n=7). A total of 271 patients with ORIF of the olecranon meeting inclusion criteria remained. Fifty-nine patients were then excluded for follow-up of less than 150 days, and 23 were excluded for lack of postoperative radiographs. Thus, 189 (70%) with acceptable follow-up remained. Hence, all patients fulfilling eligibility criteria within the indicated period were consecutively included.

Patient and surgical demographics, postoperative complications, and subsequent surgery information were obtained from electronic medical records and telephone contact.

The authors are not aware of any validated technique for evaluating hardware prominence around the olecranon. Therefore, hardware prominence was determined by measuring the most immediate postoperative lateral elbow radiograph available in 3 defined regions along the olecranon (Figures 12). Within each region, the greatest single distance perpendicular to the most superficial aspect of the cortex to the most prominent corresponding edge of the hardware was recorded. The single greatest value of these 3 points (X, Y, and Z) and their cumulative summation were also recorded. The same individual (G.B.) performed all measurements using the institutional Picture Archiving and Communication System (PACS) software system (Centricity Enterprise Imaging, GE Healthcare, Chicago, Illinois).

Example of olecranon locking plate measurement. Region X (green) is the most proximal, vertical aspect of the olecranon–hardware interface. Region Y (yellow) is along the curve of the olecranon–hardware interface. Region Z (red) is the most distal, horizontal aspect of the olecranon–hardware interface.

Figure 1:

Example of olecranon locking plate measurement. Region X (green) is the most proximal, vertical aspect of the olecranon–hardware interface. Region Y (yellow) is along the curve of the olecranon–hardware interface. Region Z (red) is the most distal, horizontal aspect of the olecranon–hardware interface.

Example of tension band measurement.

Figure 2:

Example of tension band measurement.

Statistical Analysis

Hardware prominence (hardware–bone distance), type of plate, patient age, and patient BMI were compared with the subsequent development of complication or requirement for ROH. Both overall and stratified incidence of ROH and symptom development were calculated between the variables. All patients fulfilling eligibility criteria within the indicated period were consecutively included.

Categorical variables were presented using frequencies and percentages. Continuous variables were presented using means and standard deviations because they were normally distributed. The authors assessed whether explanatory variables were associated with their primary (ie, ROH for symptoms) and secondary (ie, having symptoms or ROH) outcome measures per type of fixation (ie, plate and screws vs TB) using the Fisher exact test for categorical variables and the unpaired t test for continuous variables. Bivariate analyses were complete-case analyses (ie, excluding cases with missing values). The impact of age was further explored by dichotomizing age into above and below 60 years (median split) and assessing its association with outcome measures per type of fixation.

A 2-tailed P value (alpha) below .05 was considered significant. A power of (1-beta)=0.80 was employed for all statistical tests. Statistical analyses were performed using Stata 15.0 software (Stata-Corp, College Station, Texas).

Results

Of the 189 patients meeting inclusion criteria (70 male and 119 female), 124 fractures (43 male and 81 female) were treated with P&S and 65 (27 male and 38 female) with TB. The demographics of the two groups are listed in Table 1. Mean follow-up was 866 days (range, 151–2525 days) in the P&S group and 956 days (range, 173–2644 days) in the TB group.

Characteristics of Patients Undergoing Olecranon Fracture Fixation by Type of Surgery (N=189)

Table 1:

Characteristics of Patients Undergoing Olecranon Fracture Fixation by Type of Surgery (N=189)

The overall incidence of ROH for all cases was 55 of 189 (29.1%), with a rate of 29.0% in the P&S group and 29.2% in the TB group. An additional 20 patients (10.6%) reported symptomatic hardware but declined ROH (8.9% in the P&S group and 13.9% in the TB group) (Table A, available in the online version of the article).

Bivariate analysis of patient and radiographic characteristics associated with undergoing removal of hardware for symptoms after olecranon fracture fixation per surgery type (n=189)

Table A:

Bivariate analysis of patient and radiographic characteristics associated with undergoing removal of hardware for symptoms after olecranon fracture fixation per surgery type (n=189)

The overall combined incidence of ROH and/or symptomatic hardware that was not removed for both the P&S and TB groups was 75 of 189 (39.7%). The incidence was 37.9% for the P&S cohort and 43.1% for the TB cohort (Table B, available in the online version of the article).

Bivariate analysis of patient and radiographic characteristics associated with symptomatic hardware or undergoing removal of hardware for symptoms after olecranon fracture fixation per surgery type (n=189)

Table B:

Bivariate analysis of patient and radiographic characteristics associated with symptomatic hardware or undergoing removal of hardware for symptoms after olecranon fracture fixation per surgery type (n=189)

Demographic Associations

Patients with P&S and TB who required ROH or developed symptomatic hardware were significantly younger than those who did not (P&S, P<.003; TB, P<.004). Patients who underwent P&S olecranon fracture fixation and subsequently required ROH or developed symptomatic hardware were found to have a significantly lower BMI than the patients without ROH or symptomatic hardware (P<.045). In the TB cohort, symptomatic hardware was not associated with BMI (P=.347) (Tables A and B).

In both cohorts, patients older than 60 years were significantly less likely to undergo ROH or develop symptomatic hardware than patients younger than 60 years. In the P&S cohort, 27% of patients older than 60 years underwent ROH or developed symptomatic hardware, while 52% of patients younger than 60 years had one of these two outcomes (P=.006). In the TB cohort, 27% of patients older than 60 years underwent ROH or developed symptomatic hardware, while 57% of patients younger than 60 years had one of these two outcomes (P=.023). Furthermore, when symptomatic hardware was excluded, the statistical significance of the association of age with ROH persisted (Table 2). There was no significant difference in ROH among the various brands of plates used in this cohort.

The Association of Age With Removal of Hardware or Removal of Hardware/Presence of Symptomatic Hardware

Table 2:

The Association of Age With Removal of Hardware or Removal of Hardware/Presence of Symptomatic Hardware

A larger sample might have demonstrated significant differences for additional explanatory variables. For example, a post hoc sample size calculation—with an alpha of 0.05 and a power of 0.80—indicated that the effect size for comparing having symptoms or ROH in the P&S group based on maximum hardware prominence was 0.31 (mean, 0.71 [SD, 0.15] vs 0.76 [SD, 0.17]); assuming a similar distribution of data, the authors would have needed 346 patients to demonstrate such a small and perhaps not so relevant difference.

Hardware Associations

Mean hardware prominence for all P&S cases was 0.6 cm (SD, 0.2 cm) along region X, 0.6 cm (SD, 0.2 cm) along region Y, and 0.7 cm (SD, 0.2 cm) along region Z (Figure 1). Mean cumulative prominence was 1.9 cm (SD, 0.4 cm), and mean maximum single point prominence was 0.7 cm (SD, 0.2 cm).

Mean hardware prominence for all TB cases was 0.6 cm (SD, 0.3 cm) along region X, 0.4 cm (SD, 0.3 cm) along region Y, and 0.3 cm (SD, 0.1 cm) along region Z (Figure 2). Mean cumulative and maximum prominences were 1.3 cm (SD, 0.5 cm) and 0.6 cm (SD, 0.3 cm), respectively. These data are presented in Table A and Figure 3.

Difference in hardware prominence between locking plate and screws (P&S) and tension band (TB).

Figure 3:

Difference in hardware prominence between locking plate and screws (P&S) and tension band (TB).

There was no significant difference in hardware prominence in either the P&S or the TB group between patients who required ROH and those who did not (Table A).

The P&S cohort was found to have significantly higher prominence in regions Y and Z (P<.001) as well as cumulative and maximum prominence compared with the TB cohort (P<.001 and P=.004); however, the incidence of ROH or ROH and symptomatic hardware was similar between the two groups (Figure 3).

Other Subsequent Surgery

In the P&S group, 36 patients underwent ROH (29.0%). Of these, 13 patients had at least one additional procedure performed at the time of the ROH, including revision of hardware (n=5), incision and drainage (n=4), ulnar nerve decompression (n=3), soft tissue procedure (eg, release, debridement, capsulectomy) (n=3), and skin graft (n=1). An additional 4 patients underwent subsequent surgery without ROH, which included revision of hardware (n=2), capsulectomy (n=1), soft tissue release (n=1), and/or skin graft (n=1). In the TB group, 19 patients underwent ROH (29.2%). Of these, 7 patients had at least one additional procedure performed at the time of the ROH, including ulnar nerve release (n=3), soft tissue release (n=2), capsulectomy (n=2), removal of loose body (n=2), incision and drainage (n=2), and/or revision of hardware (n=1).

In total, 59 of 189 (31.2%) patients who were treated with ORIF for an olecranon fracture underwent subsequent surgery, including 55 of 189 (29.1%) who required ROH (20 with additional procedures) and 4 of 189 (2.1%) who required additional surgery without ROH.

Discussion

Studies comparing TB and P&S for the treatment of displaced fractures of the olecranon have found similar functional outcomes between the two methods.13–15 In 2017, Duckworth et al16 completed a prospective, randomized controlled trial comparing P&S and TB fixation in a cohort of 67 patients with simple isolated, displaced olecranon fractures. They found no significant functional difference at 1-year follow-up. They did find a higher infection rate following plate fixation, but a higher overall ROH rate following the TB technique. In 2016, a meta-analysis completed by Ren et al9 found no difference in patient-reported outcomes or elbow range of motion; however, a significant increase in complications was noted for the TB cohort.

Symptomatic hardware is a common complication following olecranon fracture ORIF due to the subcutaneous nature of the olecranon process, with reported rates of up to 50% to 75%.8 A meta-analysis by Ren et al9 found symptomatic hardware to be the most common complication, and Gordon et al17 found prominent hardware to be the main perceived complication of plate fixation.

The relative rates of ROH between TB and P&S are controversial.18–23 Higher rates of revision surgery and ROH for TB13–16 and for P&S24,25 exist in the literature. In addition, other studies have found no significant differences between these two groups.9,16,26 Although the current authors found P&S hardware to be significantly more prominent than TB hardware, the rate of subsequent ROH was 29% for each, indicating plate prominence is not the only factor affecting the decision to proceed with ROH.

Although many studies have compared outcomes of TB and P&S fixation, few studies have examined other non-hardware factors that affect ROH among these patients. A 2016 retrospective study found reoperation (mostly implant removal) following initial surgery for olecranon fracture to be less common in older patients, mirroring the findings of the current study.27 The association of ROH and age has also been studied for other commonly surgically treated fractures. In 2015, Perdue et al28 published a study reviewing more than 1.6 million patients undergoing ORIF of the tibia or fibula, not finding a significant association between ROH and age. Naumann et al29 analyzed 997 patient charts following internal fixation of ankle fractures and found that implant removal due to hardware-related complaints decreased with age (hazard ratio of 0.79 for each 10-year increase in age; P<.001), while implant removal due to infection increased with age (hazard ratio of 1.42 for each 10-year increase in age; P=.006). A 2012 study by Lovald et al30 analyzed patients who underwent internal fixation of femoral fractures, concluding that the mean age of patients undergoing ROH was 7 years younger than the mean age of the overall ORIF group (P<.0001). A 2008 study by Sidky and Buckley31 analyzing 134 tibial fractures requiring intramedullary nail fixation did not find patient age or weight to be predictors of implant removal.

The current findings demonstrated that patients older than 60 years treated with TB or P&S fixation were significantly less likely to require ROH and/or develop symptomatic hardware. This may be due to younger patients having higher demands and/or being more willing to proceed with a second surgery than older patients, who may have more medical comorbidities.

To the authors' knowledge, there is no current literature describing the relationship between BMI and ROH after olecranon fracture fixation. A 1994 retrospective study analyzing 317 charts of patients with elbow fractures found that patients requiring surgical treatment (having displaced fractures) had an increased BMI compared with those who did not.32 Overweight body mass and clinical obesity were identified as predisposing factors for elbow and ankle fractures; BMI association with possible subsequent ROH was not explored. In the current study, as BMI decreased, the likelihood of ROH and symptomatic hardware increased in P&S patients. This could have been due to less subcutaneous tissue overlying their implanted hardware.

This study had several limitations. First, ROH may be affected by both surgeon and patient biases and these could not be accounted for in a retrospective study. Therefore, the authors also analyzed symptomatic hardware that was not removed. Second, specific reasons for plate removal may not be entirely explained in the medical record. Third, patients may have undergone ROH at outside institutions after the authors' most recent follow-up data were available. Fourth, patients may have experienced symptomatic hardware that was not documented. Fifth, radiographic measurement (of hardware prominence) can be affected by variations of imaging technique. Sixth, a larger sample might have demonstrated significant differences for other explanatory variables, including hardware prominence. Finally, given the nature of this retrospective study, the authors cannot ascertain the primary reason for revision surgery when more than one procedure was performed.

Conclusion

Although ROH and symptomatic hardware are recognized complications associated with olecranon ORIF, P&S and TB fixation demonstrate similar rates of each postoperatively. Although patients treated with P&S demonstrated significantly greater radiographic hardware prominence than patients with TB, this was not associated with a difference in symptomatic hardware and ROH rates between the two groups. With both surgical techniques, the chance of a secondary, unplanned surgery remained high—31.2%. Lower BMI and younger age were both associated with higher rates of symptomatic hardware and ROH. Patients should be educated accordingly.

References

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Characteristics of Patients Undergoing Olecranon Fracture Fixation by Type of Surgery (N=189)

CharacteristicPlate and Screws (n=124)Tension Band (n=65)P
Patient characteristics
  Age, mean (SD), y57 (20)56 (18).725
  Body mass index, mean (SD), kg/m2a26 (5.0)25 (5.4).351
  Follow-up, mean (SD), d866 (621)956 (742).379
  Male, No. (%)43 (35)27 (42).428
  Right side, No. (%)56 (45)31 (48).761
  Open fracture, No. (%)16 (13)7 (11).816
  Complex fracture, No. (%)b54 (44)4 (6.2)<.001
  Brand, No. (%)
    Acumed12 (9.7)
    Biomet22 (18)
    Stryker3 (2.4)
    Synthes84 (68)
    Wright Medical3 (2.4)
Radiographic hardware prominence, mean (SD), cm
  Point X0.6 (0.2)0.6 (0.3).927
  Point Y0.6 (0.2)0.4 (0.3)<.001
  Point Z0.7 (0.2)0.3 (0.1)<.001
  Cumulative1.9 (0.4)1.3 (0.5)<.001
  Maximum0.7 (0.2)0.6 (0.3).004

The Association of Age With Removal of Hardware or Removal of Hardware/Presence of Symptomatic Hardware

Age, yPlate and Screws (n=124)Tension Band (n=65)


No. (%) No Removal of HardwareNo. (%) Removal of HardwarePNo. (%) No Symptomatic/Removal of HardwareNo. (%) Removal of Hardware + Symptomatic HardwarePNo. (%) No Removal of HardwareNo. (%) Removal of HardwarePNo. (%) No Symptomatic/Removal of HardwareNo. (%) Removal of Hardware + Symptomatic HardwareP
<6034 (63)20 (37).11125 (48)28 (52).00620 (57)15 (43).01315 (43)20 (57).023
>6054 (77)16 (23)51 (73)19 (27)26 (87)4 (13)22 (73)8 (27)

Bivariate analysis of patient and radiographic characteristics associated with undergoing removal of hardware for symptoms after olecranon fracture fixation per surgery type (n=189)

Bivariate analysis of patient and radiographic characteristics associated with symptomatic hardware or undergoing removal of hardware for symptoms after olecranon fracture fixation per surgery type (n=189)

Authors

The authors are from the Department of Orthopedic Surgery (GB, KHM, KAB, PEB, BEE), Brigham and Women's Hospital, the Department of Orthopedic Surgery (SJJ), Massachusetts General Hospital, and Harvard Medical School (GB, KHM, PEB, BEE), Boston, Massachusetts.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Brandon E. Earp, MD, Department of Orthopedic Surgery, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02215 ( bearp@bwh.harvard.edu).

Received: October 08, 2019
Accepted: December 17, 2019
Posted Online: March 20, 2020

10.3928/01477447-20200314-03

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